With upcoming changes, including the implementation of E2B(R3) and IDMP standards, the current state of safety reporting in clinical trials can be confusing. Existing safety systems may not be flexible enough to accommodate these changing regulations, which are still moving targets in the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
End-to-end safety solutions need to encompass the required service, product and technology components in order to stand up to the challenges. Many vendors claim to have such a solution, but where does one start, and what is the best solution for any given situation?
Join the speaker to learn more about:
- The current state of safety reporting and why it has been confusing
- Available solutions and the challenges they still pose
- Qualities of an ideal safety partner that blends services, technology and people to your capabilities and needs
Francois Audibert, Vice President, Global Consulting Practice, Bioclinica, Inc.
Francois leads Bioclinica’s global eHealth Solutions consulting practice specializing in data sciences, safety system and process, and overall life sciences strategy. Mr. Audibert, a 30-year industry veteran, is among the top thought leaders in life sciences technology. He brings a unique blend of technology, strategy and business expertise to Bioclinica and has worked on some of the world’s largest drug safety implementations within a global regulatory and distribution environment.
Prior to joining Bioclinica, Mr. Audibert was most recently Vice President of Pharmacovigilance at HighPoint Solutions, and prior to this was Safety Solutions Director at Oracle where he led the safety and surveillance teams into new offerings. Mr. Audibert is a graduate of Conservatoire National des Arts et Métiers.
Who Should Attend?
C-level and senior professionals responsible for quality and drug safety/pharmacovigilance.
Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with financial lifecycle, safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention solutions, and a post-approval research division.
Bioclinica’s Post-Approval Research division, a niche specialty clinical service provider, is dedicated exclusively to post-approval research. Our focus is in designing and conducting post-approval research for observational studies, post-marketing commitments, and large, simple trials. We also provide unparalleled expertise in post-approval safety studies. We offer comprehensive, innovative, technology-driven, cost-effective solutions with full-service capabilities for Pharmaceutical, biotech, and medical device companies.