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Clinical trials agility: Tips for adapting to study changes and unexpected events

Amendments? Study Changes? Event Reporting? Even managing communications to the necessary stakeholders in the right formats and timeframes has become complicated. In this webinar, learn strategies for managing “unexpected events” compliantly, including versioning, regulatory requirements, and maintaining inspection readiness.

Experts in clinical trial technology and IRB requirements discuss example scenarios illustrating how to evaluate potentially reportable events, regulatory as well as other actions that may be triggered by these events, including best practices for maintaining GCP and FDA compliance despite the unexpected.

Attendees will be able to:

Identify the types of events to promptly report to the IRB
Assess how to minimize disruptions caused by study changes
Describe safety reporting requirements and tools to deploy safety letters
Apply best practices to assure study integrity and GCP compliance post-startup

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Thomas H. Closson, BS, RPh, CIP

Vice President, Global Review Services, IRB/IBC, Advarra

Tom Closson brings over 30 years of clinical pharmacy and healthcare operations management experience to Advarra, where he oversee IRB review operations and consent services. Prior to Advarra, Tom directed Chesapeake IRB operations, where he was responsible for regulatory compliance and IRB management while also serving as an IRB member. His prior healthcare experience extends to senior management and clinical positions in numerous pharmacy practice settings, including hospital, home infusion, long term care and ambulatory care pharmacy.

Stuart Cotter

Vice President, Strategy and Innovation, Advarra

Stuart collaborates with current customers and the research community to understand their challenges and translates those challenges into innovative, solution-based enhancements to Advarra’s product offerings. He supports study teams and research sites to help them overcome their operational and regulatory hurdles. He is the product Manager for 2 of Advarra’s leading technology solutions for sponsors - Longboat and Advarra eRegulatory Management System.

moderator

Surani Fernando

Healthcare journalist, writer & podcaster

Surani Fernando is a seasoned healthcare journalist and editor with over 13 years experience covering the biopharma industry. A Sydney native, she started her investigative journalism career in London covering clinical trials, M&A and financing deals for BioPharm Insight, later moving to New York to continue her work as an enterprise journalist and editorial leader for GlobalData and Reorg. She is now based in Madrid working as a freelance journalist, consultant writer and podcast producer. In November 2023, she launched the Raising Biotech podcast.