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