Congratulations to Moderna for receiving full U.S. FDA approval for their landmark SPIKEVAX COVID-19 vaccine. Moderna’s pioneering work in developing their messenger RNA (mRNA) vaccine has played a pivotal role in mitigating this global health crisis. We are proud to support Moderna with Clinical Quality Evaluations for their COVID Clinical Programs. 

Learn more about Beaufort’s full range of Clinical Quality Oversight services and how we help sponsors demonstrate to the FDA that their trial meets the highest scientific and regulatory standards.

Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine SPIKEVAX

January 31, 2022

Approval based on a comprehensive submission package including efficacy and safety data approximately six months after second dose

SPIKEVAX has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel

807 million doses of Moderna’s COVID-19 vaccine shipped globally in 2021; approximately 25% of those doses shipped to low- and middle-income countries

CAMBRIDGE, MA / ACCESSWIRE / January 31, 2022 /Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older.

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.”

The FDA based its decision on the totality of scientific evidence shared by the Company in its submission package, which included follow-up data from the Phase 3 COVE study showing high efficacy and favorable safety approximately six months after the second dose. Moderna also submitted manufacturing and facilities data required by the FDA for licensure. SPIKEVAX has received approval by regulators in more than 70 countries.

Moderna’s COVID-19 vaccine was available under Emergency Use Authorization (EUA) in the U.S. from December 18, 2020. Under an EUA, the FDA has the authority to allow medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency when there are no adequate, approved, and available alternatives. A booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level is authorized for emergency use in the U.S. under EUA for adults 18 years and older. A third dose of the Moderna COVID-19 vaccine at the 100 µg dose level is authorized for emergency use in immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.


SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.


  • Do not administer to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
  • Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.
  • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age.
  • Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
  • Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the vaccine.
  • The vaccine may not protect all vaccine recipients.
  • Adverse reactions reported in clinical trials following administration of the vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site, and rash.
  • The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at or by calling 1-800-822-7967.

About Moderna

In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s development of a vaccine against COVID-19 (mRNA-1273, or Spikevax); the ability of Spikevax to protect against COVID-19 and prevent infection, hospitalization and death; and the safety profile for Spikevax. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Moderna Contacts

Colleen Hussey
Director, Corporate Communications
[email protected]

Lavina Talukdar
Senior Vice President & Head of Investor Relations
[email protected]

SOURCE: Moderna, Inc.

View source version on

Date posted: February 3, 2022

Categories: Articles/White Papers Press Releases and Articles Resources Uncategorized

The long-awaited Medical Device Coordination Group (MDCG) Guidance on Clinical Evidence is now available.  The 31-page document, MDC 2022-2, outlines how clinical evidence is to be demonstrated pursuant to the requirements of the IVDR. 

What does this mean for study sponsors and manufacturers? In short, the need for continuous oversight of clinical data and performance evaluation throughout the IVD’s entire lifecycle from pre-market release to post-market surveillance and follow-up. 

The guidance, which also includes more than 5 pages of definitions, details the specific principles and procedures to follow over the entire lifetime of a product, with dedicated sections across the following areas: 

  • General principles of Clinical Evidence
  • Performance evaluation process
  • The role of risk management in performance evaluation 
  • Performance Evaluation Plan (PEP) 
  • Scientific Validity, Analytical Performance and Clinical Performance 
  • Performance Evaluation Report (PER) 
  • Continuous update of the performance evaluation 

The last point on continuous performance evaluation reflects the overarching approach manufacturers must adopt, as stated in the excerpt below: 

“Scientific developments and improvements in state-of-the-art should be reviewed and assessed by the manufacturer on a regular basis as part of their continuous and pro-active postmarket surveillance activities. Therefore, manufacturers must instate a procedure for planned monitoring of scientific developments and changes in medical practice relevant to the IVD(s). Any relevant new information, developments and progress in the scientific field should trigger reassessments of the existing clinical evidence thus ensuring safety and performance through a continuous performance evaluation process.” 

This guidance document also includes an appendix on the methodological principle for generating clinical evidence as well as the required frequency for updating reports. All of which reinforces the critical need for a systematic approach to short and long-term study planning – and the benefit of having Beaufort’s highly-skilled IVDR team by your side. 

Download the Full MDCG 2022-2 Guidance Document 

Date posted: February 1, 2022

Categories: Articles/White Papers Press Releases and Articles Resources

As we move closer to the May 2022 deadline where all IVD products marketed in the EU must meet the new IVDR regulations, it is imperative for manufacturers to begin the process of implementing the mandated requirements.  To help manufacturers navigate this complex landscape, Karin Hughes, PhD, Senior Vice President, Regulatory & Quality, delivered a presentation during the 14th Annual IVD Clinical & Regulatory Affairs Conference in October, 2020. This webinar, Ensuring Compliance with IVDR Clinical Requirements, covers considerations and best practices across the following topics:

  • Developing clinical evidence reflective of a European population
  • Establishment of scientific, clinical, & analytical validity
  • Implementation of a risk based post market surveillance system
  • Confirming the IVD test adheres to “state of the art” definition


Beaufort can support all facets of your IVDR implementation. Our team of IVDR subject matter experts have an in-depth understanding of the complex details, regulatory expectations and new mandatory requirements. We provide the strategic and technical guidance to develop an appropriate project plan, as well as assist with the  implementation of any stage of the IVDR certification process.

Read more about Beaufort’s comprehensive IVDR compliance services. Interested in having a conversation? Email us at [email protected] or submit your request today.

Beaufort CRO was proud to sponsor the 14th Annual IVD Clinical & Regulatory Affairs Conference in October, 2020, and partner with Q1 Productions on this important industry event.

IVD Sponsors and CROs are tasked with identifying new processes and systems to facilitate clinical trial monitoring and management remotely due to COVID-19 restrictions. This requires developing and implementing plans to continue subject enrollment, sample collection and testing, efficient data collection and monitoring without the benefit of in-person, on-site review. The use of technology and innovation are critical to perform these clinical study tasks remotely and keep projects on track. During this webinar, Beaufort will review a case study that details the required planning and implementation of best practices to conduct monitoring visits remotely, including:

  • Factors in the Sponsor/CRO Assessments/Decision-making processes:
    • Which sites are equipped to participate in monitoring visits performed remotely?
    • Which types of visits can be performed remotely and related key considerations?
    • What technologies & processes can be used to remotely review source documents & site binder documents?
    • How to effectively communicate with the Principal Investigator and site staff without being on site?
  • Required updates to study documentation
  • Risks and Mitigations
  • Application of lessons learned to future clinical trials

Interested in learning more about Beaufort can help your business? Email us at [email protected] or submit your request today.


This webinar was recorded on November 3, 2020 in collaboration with Q1 Productions. Beaufort presenters were:

Trish Landry, MBA, RAC, CCRP, Senior Vice President, Clinical Operations

Leah Hollins, MPH, BA, Senior Clinical Project Manager

During times of increased urgency for market-ready products, including the development of COVID-19 vaccines and therapeutics, the value of comprehensive Quality Oversight (QO) becomes even greater. This is underscored by the FDA’s mandate for all sponsors to validate the work of their CRO’s and ensure the integrity of their clinical trial data and rigor of the scientific process. This is where the Beaufort team can help.  

Beaufort’s QO team are true innovators of this critically-needed service. Our comprehensive QO solutions provide an independent perspective that helps sponsors keep their commitment to developing products in accordance with the highest regulatory standards. As all businesses are adapting to the impact of the pandemic, Beaufort has continued to take the lead as our specialized teams are providing both remote and on-site QO services for a Phase 3 COVID-19 vaccine clinical trial.   

Pioneering Innovation in Quality Oversight  

Beaufort is proud to be the first to develop an independent Quality Oversight program to help sponsors objectively assess and improve CRO and site performance. We have worked with leading global sponsors and delivered a quantifiable approach to assessing data, processes and performance while optimizing the effectiveness and efficiency of their trials.   

See how a global pharmaceutical company in need of Quality Oversight for a pivotal Phase 3 trial benefited from our services. Read

The Value of Independent Quality Oversight

Why should you outsource your QO needs to Beaufort? Our dedicated QO team are experts in critically assessing and providing unbiased feedback that results in opportunities for early process improvement and cost and time savings. We also provide: 

  • Third-party assurance to regulatory agencies of your commitment to CRO oversight 
  • Independent assessments that eliminate any inherent biases that may exist 
  • Improved efficiencies and risk mitigation through co-monitoring
  • Better adherence to trial plans to reduce non-regulatory compliance
  • Real-time CAPA to prevent delays and reduce costs 

Want to learn more? Contact us today at [email protected] or read more about our Quality Oversight services or full suite of Quality Solutions. You can also read more about our comprehensive COVID-19 related services.

Date posted: September 10, 2020

Categories: Articles/White Papers Industry News Press Releases and Articles Resources

Industry Thought-Leader and Veteran Strategist to LeadFurther Expansion of Global Regulatory & Quality Services

NORFOLK, VA., July 14, 2020 —Beaufort, LLC, a leading provider of regulatory, clinical and quality solutions for in vitro diagnostic companies, recently announced Karin A. Hughes, Ph.D. as its new Senior Vice President, Regulatory and Quality. 

Hughes joins Beaufort with 20+ years of industry experience in the in vitro diagnostic (IVD), biotech and life science industries. In her past management and leadership positions, Hughes guided the strategic planning and implementation of global regulatory, clinical, and quality management programs for projects spanning early development through product clearance and continued on-market expansion. Leveraging her strong technical background and product development expertise, Hughes enabled the progress of venture-capital funded, mid- and large-sized IVD companies by providing global regulatory strategic planning, aiding in submission preparation, clinical study design and execution, and offering on-market regulatory support, as well as quality management system development, implementation and oversight.

“The global regulatory, clinical and quality in vitro diagnostic landscape is rapidly evolving due to both new and imminent regulations, such as the EU IVDR and the US VALID ACT, as well as the increasing demand for high-quality, on-market in vitro diagnostic products related to the COVID-19 pandemic,” commented Clay F. Gill, President. “The addition of Karin’s leadership to the Beaufort team presents an even greater opportunity for us to provide innovative and comprehensive solutions that meet the needs of current and future clients.”

Since 2010, Hughes held the position of Vice President Regulatory & Clinical Strategy at Astute Medical, Inc., where she established and led the company’s regulatory, clinical, quality, compliance and ethics teams. She conducted a wide spectrum of clinical trials, and secured CE mark and US FDA clearance through FDA’s de novo classification pathway for the first-of-a-kind NephroCheck® Test System. Hughes provided regulatory support to Astute’s Pharma, Medical Device and licensing partners and led the company’s strategic planning to implement the EU In Vitro Diagnostics Regulation (IVDR).

Based in San Diego, California, Hughes is an active member of the Board of the Association of Medical Device Manufacturers. Hughes holds a bachelor’s degree in Chemistry from Hartwick College, and a Ph.D. in Chemistry from the University of Virginia.

About Beaufort CRO

Beaufort CRO is a global contract research organization (CRO) that provides in vitro diagnostic (IVD), medical device and biopharmaceutical companies with a full range of regulatory, clinical, and quality solutions. For over 15 years, Beaufort has earned a reputation for its client-oriented approach to research and demonstrated success in helping sponsors accelerate the development and market readiness of their medical innovations. Our depth of experience and proven track record of working closely with regulatory agencies globally means we apply the highest level of expertise across every step of the process from project inception through regulatory clearance. Learn more at


Date posted: July 14, 2020

Categories: Press Releases and Articles

Beaufort CRO is closely monitoring the evolving circumstances surrounding COVID-19, including review of the latest state, national and international guidelines.

As this unprecedented situation continues to unfold, Beaufort remains committed to ensuring the continuity of all trials and related business while maintaining the health and safety of our employees and families, our clients and the patients they ultimately serve.

All of us recognize the critically important work you do, and the Beaufort Global Solutions Team is available to help support your needs as COVID-19 impacts your project planning and implementation activities.

In response to this crisis, Beaufort has instituted several measures including creation of a dedicated task force to continually evaluate and adapt current processes and protocols while maintaining the integrity and timeliness of all work. We have prepared our network of skilled resources to help sponsors safely meet their clinical trial planning, management, implementation and related regulatory and quality goals and deadlines. 

Beaufort has also fully transitioned to flexible and remote work locations for staff. Since a large percentage of our team already provides remote-based services, the technologies and tools are in place to continue effective support of our clients. For example, study start-ups and data management have not been impacted as we utilize secure data transmission and communications through phone, email and video conferencing. We have also adopted creative solutions for other activities, such as pre-study and qualification visits, and instituted the steps necessary to assure deliverables are completed in an efficient and high-quality manner.

Beaufort is ready to work with you and help accelerate your medical innovations during these challenging times. 

Our regular lines of communication remain open, and we encourage you to reach out to discuss any needs.

Date posted: March 24, 2020

Categories: Press Releases and Articles

As the FDA is applying increasing pressure on sponsors to validate the work of their CROs, the need for independent quality oversight has become a critical element of the clinical trial process. Beaufort is the first CRO to offer independent quality oversight services to help sponsors ensure CRO’s are performing according to expectations and commitments as mandated by the FDA and other regulatory bodies.

Beaufort’s comprehensive approach to quality oversight is based on developing a QO plan that helps maximize CRO performance and identifies opportunities for early process improvement to help prevent delays and save cost.

Read this Case Study to see how Beaufort helped a global pharmaceutical firm that needed in-process oversight of its CROs for a pivotal Phase III trial.

The Value of Independent QO for Sponsors

Date posted: October 16, 2017

Categories: Press Releases and Articles

The Association of Medical Diagnostics Manufacturers (AMDM) held its annual meeting April 24-27, with OIR Submissions and Pre-Submissions workshops April 24-26. The Beaufort team was there…here is the top news from the meeting:

Rejected: Leftover Specimens Rule Change

During the Diagnostics Update session by Khatereh Calleja, JD, senior vice president of Technology & Regulatory Affairs at AdvaMed, it was confirmed that the controversial leftover specimens rule change was removed from the Common Rule (The Federal Policy for the Protection of Human Subjects). Originally published in 1991, the Common Rule safeguards individuals who participate in research. In September 2015, HHS and the other Common Rule agencies published a Notice of Proposed Rulemaking (NPRM), including a provision that would have required researchers to obtain consent before using a study participant’s non-identified biospecimens.

Inspired by the case of Henrietta Lacks, a poor black woman whose cancer cells became widely used in research labs without her or her family’s consent, the proposed change would have required written consent for broad future use of such deidentified samples. At great cost, institutions would have had to set up systems to track the consent data, which likely would have prevented many small hospitals and clinics from providing samples for research. This was definitely a win for the research community.

(Side note: I highly recommend all clinical researchers read The Immortal Life of Henrietta Lacks by Rebecca Skloot.)

BIMO Update

FDA’s Bioresearch Monitoring (BIMO) investigators are seeing an increase in studies using leftover samples that are conducted without documented Institutional Review Board (IRB) approval. IRB approval is required when a sponsor performs a study in support of a pre-market approval application that will be submitted to FDA. Beaufort clients can rest assured that their studies receive appropriate IRB approvals and other required documentation.

Triggers for BIMO inspections remain:

  • Premarket application user fee submitted
  • New or novel technology
  • Study performed in a vulnerable population
  • Surveillance (IRBs, CRO, and GLP)
  • Complaint received at FDA from a patient or disgruntled employee

OIR Still Holding on LDT Oversight Policy

OIR Director Alberto Gutierrez, Ph.D., gave an update on the agency’s work on developing a new oversight policy for Laboratory Developed Tests (LDTs). He explained in December that FDA will wait until the new White House administration is in place before updating the LDT framework and will continue enforcement discretion.

FDA was asked by Congress not to publish final guidance or a white paper. The agency issued a discussion paper in January, but is not likely to publish anything further. Gutierrez commented that Congress stepping in will be the easiest way to resolve the issue and that he does not believe that FDA will be the determining factor.

Pre-Submissions: A One-Round Thing

During the Roundtable Discussion with OIR Management Team, Courtney Lias, Ph.D.,

director of the Division of Chemistry and Toxicology Devices at FDA, made an interesting comment regarding pre-submissions: they are meant to be a one-round thing. Some companies submit a lot of unnecessary pre-submissions. If you are not sure if you need a pre-submission, contact FDA first to inquire, or look to the recently cleared 510(k) summaries for good case studies about what’s needed. Director Gutierrez reiterated that OIR is always willing to interact.

The message here remains the same: talk to FDA. The new emphasis is on being cognizant of when a pre-submission is needed and when it’s not. And, use case studies as guides so the process is efficient.  If you need a pre-sub, try sticking to just one.  At Beaufort, this is something we regularly help our clients with. If you need help determining when to submit and when to hold back, we can guide you through the process.

IVDR: Technical Documentation Review Is the New Norm

There were two sessions on the new In Vitro Diagnostic Regulations (IVDR) in the European Union, which will take effect by the end of June. The first session described the increased regulations—and workload—­for manufactures; the second session described the extra work for Notified Bodies (NBs).

The main takeaway was that under the current In Vitro Diagnostic Directive (IVDD) 80 percent of IVDs do not have their technical documentation reviewed by an NB. Under the new IVDR, the opposite will be true: 80 percent of IVDs will require technical documentation review by an NB. Carol Ryerson, principal advisor at RCRI, recommended that manufacturers read the entire IVDR and that they write their reports as if the NB did not have access to any other documents.

Beaufort experts can help guide you through these changes to ensure that your technical documentation meets all the requirements on the NB’s checklist.



Date posted: May 9, 2017

Categories: Press Releases and Articles

Global contract research organization bolsters its commitment to delivering the highest quality services to the life sciences industry.


NORFOLK, Va., Feb. 13, 2017—Beaufort, a contract research organization (CRO), has obtained ISO 9001:2015 certification. The certification demonstrates that Beaufort provides consistently good quality services to the life sciences industry in its clinical research, regulatory affairs, quality, and staffing solutions.

“We are proud that Beaufort is one of very few CROs to obtain ISO certification,” said Beaufort President Clay Gill. “This certification reflects Beaufort’s rigorous dedication to meeting client requirements, upholding the highest quality standards, and continuously improving processes throughout our organization.”

Gill continued, “Sponsors can be confident that their projects will be conducted with the highest quality management principles and utilizing process-driven methodologies that assure our client’s work will be completed on time and on budget.”

ISO (International Organization for Standardization) is an independent, non-governmental worldwide federation that develops international standards. ISO 9001:2015, the latest edition of ISO’s flagship quality management systems standard, is a worldwide quality standard that helps organizations demonstrate that they offer products and services of consistently good quality.

“We believe a well-structured quality system is critical to the success of our clients’ work. This ISO certification provides third party validation of our commitment to a quality-first approach and helps further set Beaufort apart from other CROs,” explained John R. Wilson Jr., PhD, MPH, Beaufort senior vice president of clinical development and quality solutions.

To obtain ISO 9001:2015 certification, a firm must demonstrate that it: practices evidence-based decision making; addresses risks and opportunities in a methodical manner; and ensures that quality policy and quality objectives are established for the quality management system that are compatible with the context and strategic direction of the organization.

Beaufort’s independent assessment and certification was performed by accredited registrar Integrated Management Systems Group (IMSG).

About Beaufort, LLC

Beaufort, LLC, is a contract research organization that provides in vitro diagnostic, medical device and biopharmaceutical clinical and regulatory services, and a full range of quality solutions and staffing solutions. For more than a decade, companies worldwide have trusted Beaufort for its client-oriented approach to research. With operations spanning the globe, Beaufort has a proven track record working closely with clients and regulatory agencies internationally to bring complex and therapeutic-specific products to market. Learn more at

Date posted: February 13, 2017

Categories: Press Releases and Articles

The fall FDA‐Industry IVD Roundtable Meeting hosted by the Office of In Vitro Diagnostics and Radiological Health (OIR) of the FDA’s Center for Devices and Radiological Health took place in Silver Spring, MD on December 2nd.  Here are a few of the day’s highlights.

Post-Election, OIR Halts LDT Oversight Policy

In his opening remarks OIR Director Alberto Gutierrez, Ph.D., noted that while there may be a lot of change with a new incoming White House administration, OIR’s 2017 priorities are:

  • Quality Management
  • CLIA Waiver
  • EAP
  • Patient outreach

Gutierrez went on to give an update on the agency’s work on developing a new oversight policy for Laboratory Developed Tests (LDTs). On November 18 the agency released this statement:

“The FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions – inaccurate or false test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions.”

Gutierrez explained that FDA still believes that regulating LDTs is important, but it will wait until the new White House administration is in place before updating the LDT framework.

Also of note, OIR has introduced payer participation in pre-submissions. Even if sponsors aren’t eligible or don’t want to participate in the Parallel Review Program with CMS, they can still request CMS or private payer feedback in their pre-submission meetings if it is requested first.

Roche: FDA Collaboration Cheaper than Repeat Studies

Reena Philip, Ph.D., director of the Division of Molecular Genetics and Pathology, reviewed the first “liquid biopsy test” to be approved for non-small cell lung cancers (NSCLCs): the cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.). The Roche test was one of three to date to be granted EAP status. It is a true unmet need because Stage III/IV lung cancer patients are too sick to give a biopsy.

Roche Director of Regulatory Affairs Lesley Farrington recalled that they had been at FDA 10 times over 18 months during the submission process, and commented that it costs less to talk to FDA frequently than to repeat studies. This is why Beaufort pushes clients to do pre-submissions—FDA collaboration is vital to success!

One of the interesting parts of the process was how FDA worked with Roche on labeling. This is the first instance we have seen a “reflex” companion diagnostic; the intended use states “Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.”

AdvaMed POC Highlights Innovator Issues

Leanne Kiviharju, with the AdvaMed POC Diagnostics Subteam, presented some interesting points to consider regarding Point of Care (POC) Diagnostics.

She pointed out that “FDA has no definition for POC” and posed the following questions:

  • How does FDA educate reviewers and other groups that POC and CLIA waived tests are not the same?
  • Why does FDA identify differences in POC tests compared to mainframe tests that are also moderate complexity?
  • When a POC predicate is traceable to a standard, such as NIST, what is the scientific reason for requesting a method comparison of the new POC device with a clinical laboratory device in addition to the traceable POC device?

At the conclusion of the presentation OIR Director Gutierrez remarked that POC means near patient testing, and that the questions posed during the presentation were too narrow to be answered in a general sense and can be answered only in reference to specific projects.

The IVD Roundtable agenda and presentations can be found here.


Lucy Gibney, MD, is Medical Director at Beaufort where she provides clients with a breadth of experience in medical, scientific and clinical leadership. Lucy advises operations staff in all aspects of medical management of clinical trials, while serving as a medical expert during the project delivery lifecycle.

Date posted: December 20, 2016

Categories: Press Releases and Articles

We’re just back from AMDM’s 2016 IVD Focus Meeting. This annual event is always exciting as it brings together industry experts and thought leaders to exchange ideas, examine trends, and explore best practices. I was honored to share the stage with many peers and industry professionals over the 2-day conference and provide my perspective on the regulatory landscape during my Industry Update on day one.

Here are some key takeaways we found particularly interesting as we look ahead to 2017:

Effective regulatory strategies will take on a new twist when In Vitro Diagnostic Regulations (IVDR) in the European Union are formally published later this year.

The FDA Pacific Region Compliance Update warned that enforcement trends continue to be rigorous and firms should pay heed to having compliant QM systems. At Beaufort, we see quality management as improving quality across all GxP processes, from personnel education to data integrity.

The FDA announced the publication of the draft guidance document “Principles for Co-Development of an In Vitro Companion Diagnostic (CDx) Device with a Therapeutic Product.” This is a how-to guide that certainly will affect a sponsor’s approach to the CDx paradigm.

FDA also described the guidance document “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices,” which went into effect September 19 and provides new opportunities to sponsors wishing to address the pediatric population.

Beaufort is an industry leader in developing comprehensive regulatory solutions that address the unique needs of clients and products. We have the technical and operational experience to navigate the landscape of challenges and changes and create and manage strategies that result in success for our clients.


Date posted: October 19, 2016

Categories: Press Releases and Articles

In view of ExL’s upcoming 7th Clinical Quality Oversight Forum in Philadelphia, Beaufort quality oversight thought-leader John Wilson offers insight into some of the industry’s hot topics.

How will the revisions to the ICH E6 GCP Guidelines affect clinical quality oversight?

Revision 2 will have significant impact on quality oversight. It is important to note that there has not been a revision to ICH E6 since June 1996. Thus, when ICH goes to the effort to approve an addendum, it stands to reason that the addition is significant. With Revision 2, ICH is essentially requiring quality oversight:

    5.2.1 “The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf.”

It is clear that sponsors cannot simply point to their quality control and quality assurance efforts in this regard. The old version of ICH E6 has always required QA and QC:

    5.2.1 “A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.”

The additional language in Revision 2 can only mean that sponsors now will need to demonstrate oversight above and beyond standard QA and QC practices. Regulatory authorities will be looking for a documented, unbiased and objective assessment of the vendor CRO work effort.

Independent quality oversight is a cornerstone for Beaufort. We provide our quality oversight clients with solid documentation including a quality oversight plan listing the key processes for assessment along with methods and timelines. We also provide two reports of hard metrics. An internal report, compiled on a regular basis that contains a comprehensive, quantifiable analysis of high risk issues, is used to drive early process improvement, CAPA and provide management with real-time metrics. A second report is used during FDA inspections to demonstrate exactly what the sponsor, through third-party quality oversight, did to ensure that the CRO provided its services according to contractual and regulatory requirements.

What is the difference between clinical QA and quality oversight?

Quality oversight differs considerably from QA and should not duplicate standard QA practices. Quality oversight is about processes and adherence to contractual and regulatory requirements. It is not about co-monitoring or re-auditing the study.

There are three distinguishing characteristics between clinical quality assurance and quality oversight:

  1. Clinical QA assures the integrity of the clinical data. Quality oversight provides an assessment of how a CRO is performing relative to requirements, standards, and expectations.
  2. Clinical QA is conducted as an assessment at one point in time. Quality oversight is performed over the course of the trial and allows for real-time early process improvement and CAPA.
  3. Clinical QA is provided by the sponsor as a function within the organization. Quality oversight involves an independent organization, thus providing a totally objective assessment of the CRO work effort.

Third-party quality oversight provides an independent assessment of CRO and other vendor performance, resulting in opportunities for early process improvement and resultant cost and time savings.

How does vendor oversight change between the strategic partner, preferred provider and functional service provider models? What remains the same?

It is important to take into account which service provider model a sponsor is using in order to prescribe the best approach to vendor oversight.

In a strategic partner or preferred provider model, where a long-term relationship exists between a sponsor and its clinical trial CRO, a “familiarity bias” may exist that makes it difficult for the sponsor to adequately assess the vendor CRO’s performance. In these models vendor oversight is best executed by a third party.

In a functional service provider arrangement, while it is much less likely that familiarity would interfere with objectivity, there remains the new requirement to provide and document active vendor oversight. In this, all three models remain the same.

Risk-based monitoring has become increasingly complex. Will it continue to grow in complexity or will the pendulum eventually swing back to a simpler approach?

The answer is a bit of both. It is important to understand that the requirement is for a risk-based approach, not necessarily a complex algorithm of percentages of certain data points to monitor, for example. After performing a risk analysis, some sponsors still will choose 100% source data verification. This isn’t the same as choosing not to do a risk-based approach. Rather, their risk-based approach led them to conclude that 100% SDV was appropriate for a given trial. Others, after going through the steps of a risk analysis, determine that a more structured, less-than-100% SDV approach is optimal for a given trial.

So it is not a matter of whether the pendulum swings toward more or less SDV. What is important is that all sponsors engage in a risk-based approach in this decision making.

How can sponsors and CROs be prepared for change–whether it be in regulations, staff turnover, M&As, or other changes both anticipated and unanticipated?

My best advice: Know the regulations inside and out. Also, trust your people and the process. We have found the most successful clients are those who are systems dependent and work within a framework that ensures efficient and effective processes.

It is also critical to demonstrate active oversight. Having an effective QO program in place is important, but equally important is working with a CRO like Beaufort that has a comprehensive understanding of the regulatory environment, that is supported by a highly qualified team, and that has a proven track record of successfully managing clinical trials. Bringing skilled people to the table ensures more accountability, more flexibility and more continuity even in the midst of a changing landscape.


John R. Wilson Jr., PhD, MPH, is senior vice president, Clinical Development and Quality Solutions, at Beaufort where he is responsible for Beaufort’s quality oversight and clinical trial monitoring practices. John has worked in the health care industry his entire career and has broad-based experience in clinical research and pharmaceutical manufacturing, regulatory strategy and compliance, and quality management.


Date posted: October 5, 2016

Categories: Press Releases and Articles

We’ve just returned from RAPS’ 2016 Regulatory Convergence conference in San Jose, Calif. This year marks the 40th anniversary of RAPS’ formation to help establish the regulatory profession as a critical and distinct discipline. Today RAPS is known for bringing together regulatory industry experts and thought leaders to exchange ideas, examine trends, and explore best practices. This year’s Convergence was no exception.

Here are some key takeaways as we look ahead to 2017:

New UDI Requirements: Are You Ready?

In 2013, FDA released a final rule establishing a unique device identification (UDI) system designed to adequately identify devices through distribution and use. On September 24 UDI Requirements went into effect for Class II medical devices, including:

  • The labels and packages of class II medical devices must bear a UDI. § 801.20.
  • Dates on the labels of these devices must be formatted as required by § 801.18.
  • Class II stand-alone software must provide its UDI as required by § 801.50(b).
  • Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
  • Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.

During a RAPS workshop we learned that an industry survey has shown that the most difficult part of UDI compliance is the re-design of the labeling/packaging and updating the labeling system. The survey also showed that as of March 2016 only 62% of manufacturers were ready for FDA inspection of their UDI system.

This is precisely the kind of thought leadership that Beaufort can offer medical device manufacturers. We have the technical and operational experience to navigate the landscape of medical device regulatory changes and challenges including implementation of the new UDI requirements.

The Common Rule for the Protection of Human Subjects: Big Changes Ahead

In our opinion, the most important topic discussed for IVD manufacturers was the state of using leftover human specimens in IVD device studies.

Upcoming changes to the Common Rule for the Protection of Human Subjects could have a big impact. Under the new proposed rule, informed consent (IC) rules would become significantly tighter where IC would need to be sought for using leftover specimens for future clinical research.

Further, the new In Vitro Diagnostic Regulations (IVDR) in the European Union, set to be published in late 2016 or early 2017, also will propose big changes to informed consent. Under the proposed regulations, if patients withdraw their consent, not only will manufacturers need to discard the sample, but they also will need to remove that patient’s data from all data sets, publications and submissions.

These new rules will put bigger burdens on IVD manufacturers, making prospective studies more of the norm, even for Class II IVD studies. Now more than ever medical device manufacturers should seek guidance from third party resources to help alleviate this burden. At Beaufort we do this by developing regulatory strategies that address both industry-wide changes and the unique needs of our clients.

Preclinical Studies: Bring in Regulatory Professionals Early and Often

It was amusing when one of the workshop speakers equated regulatory affairs professionals to “traffic cops”—but they were right. An RA professional can assist with preclinical planning and design by having proactive interactions with regulatory agencies and prompt consultations with you throughout the entire IVD development process. To gain maximum value from the data that can strengthen your submission and even reduce timelines and budget, bring in Regulatory Affairs into the process early and often.

Date posted: September 29, 2016

Categories: Press Releases and Articles

Westminster, CO – February 2, 2016 – Flagship Biosciences, Inc. announces that Beaufort, LLC., an industry leading diagnostic-CRO with extensive experience in clinical regulatory services, quality solutions and staffing solutions; will be the preferred resource to strengthen its clinical trial services for Companion Diagnostics (CDx) for its pharmaceutical clients. This announcement now provides Flagship with a partner to conduct rigorous and customized end-to-end clinical trial services for pivotal PMA registration trials for immunohistochemistry (IHC) and in-situ hybridization (ISH) based CDx. This includes support of standard, manual pathology based CDx, as well as development of advanced tissue image analysis based CDx.

“This partnership allows Flagship to strengthen our commitment of providing our customers a continuous path for the development of their exploratory tissue image analysis solutions into Companion Diagnostics.” said Dr. David Young, CEO and President. “Working with Beaufort further positions our company to more effectively drive our image analysis based Companion Diagnostics (CDx) as a sponsor and to manage all relevant aspects of a PMA registration trial.”

Dr. Holger Lange, Chief Technology Officer at Flagship, has led the initial phases of this collaboration, which have yielded fully developed Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) for Clinical Trials according to the harmonized ICH guideline for good clinical practice (E6), to support IVD-track assay and image analysis development strategies.

“The continued collaboration will enable the development of novel, high complexity assay and image analysis interpretations to meet the needs of immuno-oncology patient selection strategies, under efforts which have been sponsored by Flagship Biosciences and its pharmaceutical customers” said Dr. Holger Lange.

“Tissue image analysis allows us to bring more complex biomarker assays into the clinic, allowing our Pharma customers to provide more effective drugs, and ultimately to save lives. The fast growing field of immuno-oncology is requiring the creation of in situ based tests which are too complex for human interpretation, and must be interpreted using tissue image analysis.” said Dr. Joseph Krueger, Chief Scientific Officer. “The application and adoption of our technology is being adopted quickly in this space, and we must be sure to enable success for obtaining regulatory approval for our technology for our customers”.

“Beaufort’s success is rooted in helping our clients and partners accelerate medical innovation,” said Clay Gill, President of Beaufort, LLC. “We are excited for the opportunity to collaborate with Flagship, a leading innovator in specialty tissue image analysis, to deliver clinical services and solutions that will help advance drug development in the clinical market.”

About Beaufort
Beaufort, LLC, is a contract research organization that provides in vitro diagnostic, medical device and biopharmaceutical clinical and regulatory services, and a full range of quality solutions and staffing solutions. For more than a decade, companies worldwide have trusted Beaufort for its client-oriented approach to research. With operations spanning the globe, Beaufort has a proven track record working closely with clients and regulatory agencies internationally to bring complex and therapeutic-specific products to market. Learn more at

About Flagship Biosciences
Flagship Biosciences, the industry leader in tissue image analysis, advances precision medicine by quantifying and simplifying complex pathology utilizing advanced image analysis technology. The company’s comprehensive “fit for purpose” image analysis solutions transform conventional, subjective methods of histopathology with clear actionable data to speed global drug development and approval.

Date posted: February 2, 2016

Categories: Press Releases and Articles

On August 14, 2015, the eMDR final rule goes into effect, requiring manufacturers to submit medical device reports (MDRs) to the FDA electronically rather than in paper form. Electronic submission expedites report processing and reduces the burden of data entry on the FDA, manufacturers, and importers. There are two options available to all reporters for submitting eMDRs: eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR).

On June 19, the FDA released an updated implementation package with the system requirements to enable manufacturers that chose the HL7 ICSR submission option to prepare for and test eMDR submissions.

As a reminder, both eSubmitter and HL7 reporting options transmit MDRs to the FDA using the FDA Electronic Submission Gateway (ESG), a secure entry point for all electronic submissions to the Agency.

Manufacturers should consider registering for an ESG account and submit a test submission as soon as possible to ensure that they are electronic submission compliant by August 14, 2015, regardless of which transmission method they choose. Manufacturers may begin testing their submissions as early as June 29, 2015.

Information on the FDA ESG and steps to obtain a production account, please visit the Electronic Submissions Gateway page.
Date posted: June 22, 2015

Categories: Press Releases and Articles

“What’s past is prologue.” —The Tempest, Shakespeare

If there’s one thing that history teaches us, it’s that history repeats itself. To get a picture of what the regulatory landscape will look like tomorrow, it’s important to understand what it looked like yesterday, and how we got to where we are today. Through this lens, we should examine two current initiatives that could both directly and indirectly affect the regulatory and policy environment of the future: 21st Century Cures, and the proposed Regulatory Framework for In Vitro Clinical Tests.

21st Century Cures Initiative
The 21st Century Cures Act (H.R. 6), currently being discussed in the U.S. House of Representatives, addresses reforms not just for diagnostics, but across all FDA centers. It is a draft legislation created by the House Energy and Commerce Committee’s leadership. Co-sponsored by Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), and released with the support from members of both parties, the bipartisan initiative aims to improve innovation for new treatments and tests, and to streamline approval efforts by the FDA.

Amendments intended to improve innovation in healthcare are not new. First came the Medical Device Amendments, added to the Food, Drug and Cosmetics Act (FD&C) in 1976, but other amendments have followed.

Among them was the Safe Medical Devices Act (SMDA), signed into law by George H.W. Bush in 1990. The SMDA primarily instituted Medical Device Reporting (MDR), which requires safety related issues, both real and potential, to be reported to the U.S. Food and Drug Administration (FDA). Few would argue that the amendment has not improved the safety of devices, but it was not focused on innovation or process improvement.

In 1997, the Food and Drug Administration Modernization Act (FDAMA) amended sections of the FD&C Act relating to the regulation of food, drugs, devices, and biological products. With the passage of FDAMA, Congress enhanced the FDA’s mission, recognizing that the agency “would be operating in a 21st century characterized by increasing technological, trade and public health complexities.”

After the first two user fee-related medical device amendments in 2002 and 2007, a third amendment in 2012, called the FDA Safety and Innovation Act (FDASIA), gave the FDA a powerful drug development tool: Breakthrough Therapy Designation. This designation assists drug developers by expediting FDA review of new drugs that are supported by preliminary clinical evidence indicating the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.

FDASIA also sought to further innovation by including draft guidance on the process for approving applications for medical device clinical investigations. It also permits the FDA to review “direct” (rather than the previously cumbersome “sequential step”) de novo device submissions.  FDASIA also attempted to engage stakeholders more in FDA review and decision-making.

So, how should we view the 21st Century Cures initiative, given this historical perspective? It is safe to say that, once medical issues surface for discussion, the legislature generally has acted for the betterment of public health. True to that historical standard, legislation likely will pass that makes changes for the better, to improve innovation and process.

21st Century Cures also could result in an organizational restructure at the FDA. The legislation, as it currently is written, contains a great number of reforms: Clinical Laboratory Improvement Amendments (CLIA) waiver study design guidance for in vitro diagnostics (IVDs), expediting patient access, notification of marketing of certain Class I devices, priority review for breakthrough devices, telemedicine, FDA advancement of precision medicine, and improving scientific outreach for the agency. Any one of these reforms could open the door to an FDA organizational restructure and, considering the grand scope of the initiative, it is hard to imagine that some sort of organizational restructure won’t occur.

However, 21st Century Cures remains silent on regulation of laboratory developed tests (LDTs). The nature of the FDA’s involvement in oversight of LDTs is a hot topic within the industry, and it will be very interesting, to say the least, if the legislation moves forward without requiring or allowing that oversight.

Regulatory Framework For In Vitro Clinical Tests
The Regulatory Framework for In Vitro Clinical Tests proposal was a creation of the diagnostic industry, rather than government, spearheaded by the membership of AdvaMedDx, the largest group representing this industry. The proposal was developed to potentially replace the existing regulatory structure for all diagnostics (both manufacturer and LDT), regardless of site and entity. Under the proposal, the FDA, the Centers for Medicare and Medicaid Services (CMS), and other stakeholders would engage in any legislative process for statutory changes.

This proposal is related directly to the LDT Framework, merging it with the Transitional In Vitro Diagnostic Test (TIVD) proposal offered to the FDA by industry a few years ago. The TIVD eventually was embraced by Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, and a pilot program currently is underway with multiple manufacturers participating. If this program is successful — and it should be — it could change the way we look at how product approvals should occur in the future.

History dictates that some version of the framework will continue forward as-is. But it remains possible that the FDA’s effort to regulate LDTs could be undermined by  21st Century Cures or something more extreme, such as a lawsuit by the lab community.

What’s Past This Prologue?
Historical knowledge provides precedence that, if we are smart, can guide current and future decision-making to benefit the public health.

Through the lens of historical knowledge, we can see that, once discussion of reform begins, movement generally continues toward action. We also can see that, when all stakeholders are involved and cooperate, public health benefits. Public meetings, agency outreach, and guidance comments are very important in developing fruitful outcomes. Today, cooperation between agency and industry is at its highest level ever. This bodes well for the future and ensures the best possible outcome for all parties.

Robert Di Tullio, Senior Vice President, Global Regulatory Services

Date posted: June 3, 2015

Categories: Press Releases and Articles

NORFOLK, VA., May 13, 2015—Beaufort, LLC, a contract research organization (CRO), has announced that Clay Gill has been promoted to president of the company.

“This appointment constitutes a great step for Beaufort, as we further position our organization as an industry-leading CRO,” said Beaufort Chairman and CEO Alfred F. Ritter, Jr.

Gill joined Beaufort in 2010 and is responsible for leading Beaufort’s global operations in clinical and regulatory services, quality solutions and staffing solutions. Through her leadership, passion and vision, she successfully manages multidisciplinary teams that deliver creative and effective solutions to complex and evolving business challenges.

“Her ability to deftly align sales, marketing and operations while keenly understanding a client’s individual needs is a critical factor in helping Beaufort consistently deliver program success for our clients,” commented Ritter.

About Beaufort, LLC
Beaufort, LLC, is a contract research organization that provides in vitro diagnostic, medical device and biopharmaceutical clinical and regulatory services, and a full range of quality solutions and staffing solutions. For more than a decade, companies worldwide have trusted Beaufort for its client-oriented approach to research. With operations spanning the globe, Beaufort has a proven track record working closely with clients and regulatory agencies internationally to bring complex and therapeutic-specific products to market. Learn more at

Date posted: May 13, 2015

Categories: Press Releases and Articles

The Association of Medical Diagnostics Manufacturers (AMDM) held its annual meeting April 22-23, with an OIR Submissions workshop and Pre-Submissions workshop April 20-22.  The two workshops were “FDA 101” for regulatory professionals, with the majority of speakers being from the FDA and covering all aspects of OIR submissions.  But, even for seasoned regulatory professionals, there was plenty to learn.

For example, there was a session on FDA’s Medical Device Development Tool (MDDT) pilot program, to which FDA has accepted five proposals.  MDDT is a voluntary process to qualify tools that are used in the development and evaluation of medical devices outside of the regulatory submission; they are intended to save time on the development and review side. There also was a session on Unique Device Identifiers, or UDIs, which are global unique numbers that will identify almost every individual device. UDI compliance is already in effect for Class III devices and the majority of Class II devices will need to comply by September 24, 2016.

Of course, it wouldn’t be an FDA-industry meeting without a discussion of Laboratory Developed Tests (LDTs).  Elizabeth Hillebrenner, policy advisor at FDA, gave an overview of the proposed LDT regulation during the OIR Submissions workshop and Liz Mansfield, deputy officer director for personalized medicine at FDA, gave an update on LDTs and personalized medicine during the final day of the annual meeting. In response to the draft guidance documents, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), the FDA received more than 1,400 comments from approximately 300 individual commenters. FDA also announced that it has formed a joint task force with CMS on LDT quality requirements so as to not duplicate compliance efforts.

Overall, the AMDM workshops and annual meeting provided a great opportunity for learning and networking, allowing Beaufort to continue to stay in the forefront with regard to FDA thinking and new industry developments.

Date posted: May 8, 2015

Categories: Press Releases and Articles

FDA recently announced that FDA and CMS will form a task force to focus on the quality requirements of laboratory developed tests (LDTs). The overall goals of the task force are to clarify the roles of the two agencies and avoid a duplication of efforts.

Last fall, FDA released two draft guidance documents here and here in which FDA would phase in the enforcement of premarket review requirements, FDA notification and MDR requirements, and the quality system regulation requirements for a subset of LDTs. FDA’s goal in overseeing LDTs is to assure that they are analytically and clinically valid. “We intend to clarify the terms used so that labs may better understand what is expected of them,” explained Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, and Patrick H. Conway, MD, MSc, acting principal deputy administrator CMS Chief Medical Officer.

The goals of the task force also include:

  • To identify areas of similarity between the FDA quality system regulation and requirements under CLIA.
  • To clarify responsibilities for laboratories that fall under the purview of both agencies.
  • To leverage joint resources to maximize efficiency.

The oversight of LDTs is highly sensitive, as it directly affects patient care. The agencies are optimistic that formalized coordination can lead to accurate tests and clinically meaningful outcome information.

A experienced regulatory consultant can help navigate the premarket review and quality system regulation requirements for LTDs.

Trish Landry, MBA, RAC, CCRP

Date posted: April 30, 2015

Categories: Press Releases and Articles

(Norfolk, VA; April 14, 2015) — Beaufort, a global contract research organization that partners
with in vitro diagnostic (IVD), medical device and biopharmaceutical developers to provide
clinical and regulatory services and a full range of quality and staffing solutions, will celebrate its
tenth year as a member of the Association of Medical Diagnostics Manufacturers (AMDM). The
company is sponsoring the AMDM Annual Meeting, April 22–23 in North Bethesda, MD, and will
participate in two seminars.

“Our clients have relied on our team’s perspective for best practices and coming trends
in IVD research for more than a decade,” said Schuyler Ritter, Beaufort senior vice president of
business development and cofounder.

Beaufort recently hired Robert Di Tullio as senior vice president of global regulatory
services and Melissa Barhoover, Ph.D., RAC, as clinical and regulatory affairs manager. Both
will speak at the AMDM Annual Meeting on topics that reflect their areas of expertise and
Beaufort’s services.

melissa-barhoover In Vitro Companion Diagnostic Device Case Studies
Wednesday, April 22, 3:15–3:45 p.m., presented by Melissa Barhoover, Ph.D., RAC
robert-ditullio The Changing Regulatory and Policy Environment for Diagnostics: What to Expect in 2015 and Beyond
Thursday, April 23, 9–9:45 a.m., presented by Robert Di Tullio

Di Tullio has 40 years’ experience in the IVD industry, including nearly three decades in
regulatory, clinical and quality management. Di Tullio’s strategic expertise will help Beaufort’s
clients achieve success while ensuring compliance with global regulations and initiatives.
Barhoover’s background stems from 15 years of experience in clinical chemistry and molecular
biology as well as project management and regulatory affairs for IVD development.

“These individuals are deeply embedded in the IVD industry,” said Ritter. “Their
expertise in clinical and regulatory affairs will further our ability to provide customized, reliable
and effective solutions.”

Date posted: April 14, 2015

Categories: Press Releases and Articles

In “Five Steps for Improving Processes in Clinical Trials,” Beaufort’s John Wilson introduces the five-step process for improving business processes.  The article provides an introduction to the five steps, using risk-based monitoring (RBM) as an illustrative example. Wilson states that only after completing the first four steps (map, analyze, redesign, and assign resources) can we productively move on to the fifth step (implement improvements), in which a process is actually improved. This article appeared in the January 2015 Journal of Clinical Research Best Practices.

Date posted: January 8, 2015

Categories: Press Releases and Articles

Beaufort assesses CRO and site performance at clinical sites around the world

NORFOLK, Va., June 20, 2013—Beaufort has been retained by three life science companies to conduct quality oversight programs. Beaufort Quality Oversight provides an independent, continuous and comprehensive assessment of the CRO’s overall process and performance.

Beaufort has been retained by a top pharmaceutical company to perform quality oversight services for two clinical trials. Beaufort senior clinical research professionals located in Europe, Asia-Pacific, North America, and South America will perform assessments of CRO and site performance at clinical sites in 38 countries.

Beaufort also has been retained by a leading provider of innovative pain management therapies to perform quality oversight services for a clinical trial of a controlled substance at 20 sites throughout the U.S. Beaufort’s quality oversight services will include ongoing recommendations for improvement.

Beaufort continues to provide quality oversight services for a top 20 worldwide pharmaceutical company. The company’s director of clinical operations said of the program, “Beaufort’s innovative quality oversight program allows us to ensure the integrity of our clinical research data and exceed FDA requirements.”

Beaufort Quality Oversight is well-aligned with regulatory authority expectations for greater oversight of CROs and other clinical service providers. Independent quality oversight also provides an opportunity for early process improvement, allowing these organizations to identify process enhancements which could improve trial conduct.

“Our partnerships represent a unique value proposition for which Beaufort is an innovator and thought leader,” said John Wilson, Beaufort senior vice president and practice leader. “It provides these organizations an avenue to answer with confidence the question frequently asked during inspections:  How do you know your CRO is performing according to expectations?”

Beaufort Quality Oversight is an independent CRO assessment service that provides unbiased, independent assurance that the CRO is performing according to requirements. Beaufort’s niche in the market allows the firm to establish collegial and collaborative relationships with the CROs that manage global clinical trials.

Beaufort representatives will be available to discuss quality oversight and other Beaufort services during the 49th annual meeting of the Drug Information Association, June 23–27 in Boston. Beaufort will exhibit in booth #1916 in the Exhibition Hall.

Date posted: June 20, 2013

Categories: Press Releases and Articles

In “Some Quality Food for Thought,” Beaufort’s John Wilson questions why quality improvements in clinical research are so slow to come about. Wilson suggests that the industry commit to systematic, practical and measurable applications of basic principles and he cites four areas that often are overlooked. This article appeared in the October 2012 Journal of Clinical Research Best Practices.

Date posted: October 5, 2012

Categories: Press Releases and Articles

In this article from the May 2012 issue of the Journal of Clinical Research Best Practices, Beaufort’s John Wilson argues that clinical research can benefit from QBD. Pharmaceutical manufacturing established a risk-based approach to quality more than a decade ago, yet its adoption in clinical trials has been slow. As the pressure for fundamental change in clinical research quality continues to grow, we can learn much from our colleagues in pharmaceutical manufacturing.

Date posted: May 1, 2012

Categories: Press Releases and Articles

In the pharmaceutical industry, quality by design (QbD) has long been applied to manufacturing. Incorporating good manufacturing practices (GMP) into the production process is expected and required by the Food and Drug Administration (FDA). Yet, rarely are QbD practices adopted before the drug enters commercial production.

The problem with not following QbD prior to commercial production is that it is extremely difficult to insert or force quality into a suboptimal process.  Doing so leads to awkward and inefficient practices, duplicative efforts and “Band-Aid” approaches to quality. Building a quality pharmaceutical begins with building quality into the research and development phase.

One may argue that QbD is already built into R&D through clinical quality assurance (QA). While QA certainly is an important part of clinical research, it does not build quality into the process. Because it is traditionally conducted as an assessment at one point in time, it does not provide a continuous assessment over the course of the trial and therefore cannot be considered as part of the process.

What can pharmaceutical companies do to build quality into research and development? They can implement a third-party quality oversight program. Quality oversight upholds the principles of QbD, because it is performed over the course of the trial and it represents a simultaneous exchange of information that allows for real-time corrective and preventive action (CAPA).

What is quality oversight?
Third-party quality oversight provides an unbiased and objective assessment of the vendor contract research organization (CRO) work effort. Sponsors utilize many processes to evaluate the quality of their clinical trial data; however, the bias that may exist in a long-term relationship between a sponsor and its clinical trial CRO makes it more difficult for the sponsor to adequately assess the vendor CRO’s performance. Third-party quality oversight eliminates this bias and provides reliable information in real time.

An optimally structured quality oversight program should not result in any duplication of effort on the part of the sponsor. Quality oversight is all about processes and adherence to contractual and regulatory requirements. It is not about co-monitoring or re-auditing the study.

Quality oversight builds quality into a clinical trial by ensuring that CRO performance meets FDA and other regulatory body requirements and that the work also meets FDA expectations.

Let’s take a closer look.

Ensure that CRO performance meets FDA requirements
While sponsors always have been responsible for the quality of their vendors’ work, it is now clear that sponsors also are being held directly accountable for that quality. Nowhere is this more evident than in the case of recent FDA warning letters issued to top-quality pharmaceutical firms for failure to oversee the activities of their vendors.

Problems don’t have to reach warning letter status to attract the attention of regulatory authorities. Several sponsors have reported that FDA investigators are specifically asking how the sponsor oversees the activities and assures the quality of its clinical vendors. This is a legitimate question and one that industry sources expect will gain more currency as part of the inspectional process. Third-party quality oversight answers this question.

Ensure that the work meets FDA expectations
FDA’s good clinical practice (GCP) requirements are quite thin—most are expectations of ethical and scientific quality standards rather than codified regulations. So how can a sponsor successfully navigate what could become a mine field of expectations? By retaining an expert with significant experience in FDA submissions.

The quality oversight provider should have extensive experience in GMP as well as GCP in order to bring GMP-quality methodology to the clinical process. The quality oversight team should be comprised of senior clinical research associates with significant experience in this type of activity. Through accrued experience, the quality oversight provider should thoroughly examine the CRO work effort and authoritatively weigh its adherence to FDA expectations.

Incorporating QbD into research and development through third-party quality oversight of clinical trials helps pharmaceutical companies ensure that FDA requirements and expectations have been met long before a drug enters commercial production. Entering production without this assurance can mean costly delays and unnecessary re-work.

This article appeared in Pharmaceutical Compliance Monitor on January 16, 2012.

Date posted: January 30, 2012

Categories: Press Releases and Articles

Today’s clinical trials require quality oversight for one simple reason: sponsors are ultimately responsible for the integrity of the data generated by their third-party vendors. This is most evident in recent FDA warning letters issued to top-quality pharmaceutical firms for failure to oversee the activities of their contract research organizations and other vendors.

Even before reaching warning letter status, problems are attracting the attention of regulatory authorities. FDA investigators are asking how sponsors oversee the activities and assure the quality of work performed by their clinical vendors. Quality oversight answers this question.

A third-party quality oversight program provides an unbiased and objective assessment of the CRO’s work effort. It eliminates the inherent bias that may exist in a long-term relationship between a sponsor and its CRO—a bias that makes it difficult for the sponsor to adequately assess the CRO’s performance.

An optimal quality oversight program provides real-time assessment and reporting of CRO field activity; it is not about co-monitoring or re-auditing, and it is not clinical quality assurance. Rather, it provides a comprehensive assessment of the CRO’s overall process and performance.

Quality oversight is well-aligned with the FDA’s Clinical Trials Transformation Initiative and, as it is accepted as a critical trial process by a large number of firms, will increase its positive impact. It also is aligned with the FDA’s call for industry to be more innovative in its clinical trial work. A trial-specific, formal quality oversight plan could be part of any prospective trial review conducted under the agency’s pilot initiative for adaptive clinical trials.

Most important, a solid, metrics-driven quality oversight report can greatly facilitate the inspection process, particularly when FDA investigators ask “How do you, sponsor, know that the CRO is doing what it is supposed to be doing?”

This article appeared in the October 2011 CenterWatch Monthly.

Date posted: January 12, 2012

Categories: Press Releases and Articles

Quality oversight of clinical trials gains traction as sponsors are held accountable by the FDA

NORFOLK, Va., July 20, 2011—Clinical research organization (CRO) Beaufort has added quality oversight to its services for clients in the pharmaceutical, diagnostics, and medical device industries.

Beaufort has been engaged by a Top 20 Global Pharmaceutical Company to conduct quality oversight monitoring (QOM) visits for the company’s clinical trials. The partnership will help the company successfully manage vendor quality and compliance during clinical trials in a uniform, quality-focused, efficient, and effective manner.

“The need for quality oversight monitoring continues to grow,” said John Wilson, Beaufort senior vice president of clinical operations. “Increased scrutiny and enforcement activity from the FDA and other regulatory agencies has heightened awareness among sponsors and CROs of the need to ensure the integrity of clinical research data.”

The Beaufort quality oversight team will provide the pharmaceutical company an understanding of how each of its studies is being conducted by the company’s other CROs. Beaufort will not audit the CROs, but will observe, critically assess and provide objective and unbiased feedback on the respective CRO clinical research associates’ level of knowledge, experience and training for the specified trials. The company can then use those observations to provide feedback to the CRO.

Sponsors of clinical investigations, as well as CROs, have come under increased scrutiny recently from the Food and Drug Administration (FDA) for failing to ensure proper monitoring of clinical trials. The FDA holds sponsors ultimately responsible and accountable for the quality of work performed on their behalf. Recent FDA BIMO audits have cited numerous diagnostic, drug and device companies for multiple issues such as:

–Failure to follow the protocol

–Failure to keep adequate and accurate records

–Problems with the informed consent form

–Failure to report adverse events

–Failure to account for the disposition of study drugs

“Quality oversight by a niche CRO provides significant advantages over co-monitoring and re-monitoring approaches,” explained Wilson. “It provides an unbiased, third-party assessment of the clinical trial that saves the sponsor valuable time, and it avoids the conflict of interest inherent in utilizing a larger CRO to oversee another’s work.”

About Beaufort

Beaufort is a clinical research organization dedicated to accelerating medical innovation in partnership with its clients in the pharmaceutical, diagnostics, and medical device industries. The company’s range of highly customizable services includes regulatory strategy and compliance, clinical research, quality assurance, and quality oversight. For more information visit

Date posted: July 20, 2011

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