- Quality Oversight: The Key to Optimizing Your Clinical Trial During COVID-19 September 10, 2020
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 ...
- Beaufort CRO Names Karin Hughes, Ph.D. as Senior Vice President, Regulatory and Quality July 14, 2020
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 ...
- Beaufort’s Response to COVID-19 March 24, 2020
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 ...
- Case Study: The Value of Independent Quality Oversight for Sponsors October 16, 2017
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 ...
- AMDM 2017: A Look Back May 9, 2017
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, ...
- CRO Beaufort Obtains ISO 9001:2015 Certification February 13, 2017
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 ...
- Highlights from FDA Industry IVD Roundtable December 20, 2016
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 ...
- Looking Back at AMDM October 19, 2016
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 ...
- Beaufort Insights: ExL’s Clinical Quality Oversight Forum October 5, 2016
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 ...
- RAPS Unwrapped September 29, 2016
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 ...
- Flagship Biosciences and Beaufort, LLC partner to provide Clinical Trial Services for the Pharmaceutical Industry February 2, 2016
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 ...
- FDA’s Electronic Medical Device Reporting (eMDR) Compliance Deadline June 22, 2015
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 ...
- The Changing Regulatory and Policy Environment for Diagnostics: What to Expect in 2015 and Beyond June 3, 2015
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“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 ...
- Clay Gill named president of Beaufort May 13, 2015
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 ...
- Spring AMDM in Review May 8, 2015
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 ...
- FDA / CMS Task Force on LDT Quality Requirements Is a Step in the Right Direction April 30, 2015
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 ...
- Beaufort to Sponsor AMDM Annual Meeting; New Hires to Speak at Thought Leadership Event April 14, 2015
(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 ...
- Five Steps For Improving Processes In Clinical Trials January 8, 2015
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 ...
- Beaufort Quality Oversight Is Retained By Three Life Science Companies June 20, 2013
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 ...
- Some Quality Food For Thought October 5, 2012
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.
- High Standards May 3, 2012
In this Spring 2012 International Clinical Trials article, Beaufort’s John Wilson argues that clinical trial sponsors can reduce the total cost of quality by implementing a third-party quality oversight program. Read the entire issue here.
- Quality By Design: Manufacturing Has It Right May 1, 2012
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 ...
- Quality Oversight Brings Quality By Design To R&D January 30, 2012
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 ...
- Quality Oversight In Every Clinical Trial January 12, 2012
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 ...
- Third-Party Quality Oversight: Designing An Optimal Programme January 4, 2012
“Third-party quality oversight: designing an optimal programme” was published in the August 2011 issue of Scrip Regulatory Affairs (see www.scripregulatoryaffairs.com).
- Clinical Research Organization Beaufort Introduces Quality Oversight Services July 20, 2011
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) ...