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.
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
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
Communication and questions were the theme on November 28 at FDA’s Public Workshop on Troponin Assays — all about the opportunities and quandaries associated with high sensitivity and not so high negative predictive value. Consistent with this, slide decks were short and most of the time was spent in five different panel discussions. Below is a list of topics covered and a few notable points from each. Also, here’s a link an FDA page with recorded proceedings listed in sections – Part 1 through Part 4 – under Webcast Archive and Slides.
We’ll be watching for next statements and next steps from FDA, and we’re ready to work with clients who have pending matters in each of these areas.
Cut-Off Determination/Reference Interval Studies
Which subjects to enroll
How to analyze the data
What to do with outliers
Clinical Trial Design
Precision around each assay’s unique cut-off
Rapid rule out of MI
Informed consent challenges
Pre-Analytical and Analytical Considerations for Clinical Trials
Lab-to-lab and analyzer differences
Clinical Trials for Point of Care Devices
Sample matrix performance differences – whole blood vs plasma
Fresh vs transported samples
Use of Existing Clinical Data to Support Claims
Beaufort, a leading diagnostic CRO and Regulatory consultancy, is experienced in assisting clients with Troponin assay goals. We work with both clients and sponsors in developing assays and managing every stage of your clinical trial. Contact us to learn more about how we can support your Troponin and other clinical, regulatory, quality and staffing needs.
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.