How does the latest revision to The International Council for Harmonization (ICH) Good Clinical Practice (GCP) E6 guideline affect risk-based monitoring (RBM) strategies, and what role does ICH GCP E6 (R2) play in sponsors’ expectations of contract research organizations (CROs)?Those are just a few of the topics that will be on the table when executives from Chiltern, PRA Health Sciences and Algorics gather at the Risk-Based Monitoring (RBM) Symposium – a complimentary event organized by OmniComm Systems at the North Carolina Biotechnology Center on Wednesday, November 8.
Speakers and Topics
Speakers include: Debra Jendrasek, vice president and strategic development partner at Chiltern; Nithiya Ananthakrishnan, founder and CEO at Algorics; John Mann, vice president at PRA Life Sciences, and Neil Vivian, senior director of business solutions at OmniComm.
Deb Jendrasek is Chiltern’s liaison with ACRO and the CRO Forum for TransCelerate’s RBM workstream and has presented at many industry conferences on the topic of RBM. She will lead the RBM workshop at the upcoming Society for Clinical Data Management Annual Conference 2017. Nithiya Ananthakrishnan founded Algorics with the goal of providing innovative risk-based monitoring and clinical analytics solutions to the life sciences industry.
John Mann, MS, PMP, is currently a vice president of project delivery at PRA Health Sciences. He has 19 years of clinical research experience in the CRO industry and has been on PRA's Adaptive Monitoring Initiative (RBM) leadership team for the past two years.
Neil Vivian has 39 years of experience in the software industry, including 25 years focused on life sciences. His expertise includes risk-based monitoring, eSource and integration projects. He was part of the team for the "2015 FDA CDER End-to-End EHR-to-EDC Single-Point Data Capture" submission.
Sample Symposium Topics:
- Expectations: What does a sponsor expect the CRO to handle on its behalf?
- Considerations: What are the considerations for enabling ICH E6 (R2) from an integrated risk-based management technology?
- Exploration: What can be learned from reviewing case studies in EDC risk-based monitoring?
Registration is free for this educational event planned for the Raleigh-Durham clinical trials community.