Peter Schaeffer–Projects, Clinical Platforms and Sciences Third Party Resourcing Analytics Director at GlaxoSmithKline
Laura Galuchie–TransCelerate Program Lead at MSD
Melissa Suprin–Head of Quality Risk Management at Pfizer
Esther Huffman O’Keefe–Associate Director – Monitoring at Regeneron Pharmaceuticals, Inc.
Join us for a panel discussion as experts explore how existing TransCelerate solutions can support Clinical Trial Continuity during times of disruption.
The panel will feature experts from TransCelerate initiative teams with specific knowledge around the below areas:
- Tools to support centralized trial monitoring: TransCelerate’s Risk Based Monitoring methodology and tools can be leveraged to transition from conventional, onsite monitoring. The model guidelines for targeted, risk-based clinical trial monitoring, ultimately aiming to improve data quality and patient safety. The methodology and tools can be adopted by any size organization and adapted to any type or phase of a clinical trial.
- Tools to support protocol deviation management: With the COVID-19 pandemic drastically affecting clinical trial operations, protocol modifications may be required and there may be unavoidable protocol deviations. To help stakeholders navigate multiple aspects of protocol deviation management, TransCelerate has released a Protocol Deviations Toolkit . The toolkit offers a proposed clarification of the definition of “important” deviations and provides a holistic approach to protocol deviations management, including a process guide, process map, decision tree, and an assessment tool. These tools were developed with feedback from Sites, CROs, and Health Authorities.
- Tools to support issue & risk management: A Quality Management System aims to address quality and monitor and improve performance in complex clinical development-specific environments. TransCelerate’s Risk and Issue Management tools provide a conceptual framework to provide end-to-end management of risks and issues and support an effective Corrective and Preventive Actions (CAPA) process.
- Tools to support use of patient-friendly technology: TransCelerate’s Patient Considerations Guide provides insights on patient perspectives and key considerations for using technology in clinical trials. As global health authorities have surfaced that trial participants may not be able to visit the investigational site for protocol specified visits, sponsors may evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit) could be used. The guide provides considerations to aid a sponsor’s decision to use technology with patients to help in the current environment.
Leading up to this panel discussion, we will be sharing recordings that dive into the details of each solution and how it can be leveraged. We invite you to watch this content prior to joining our panel of experts as they look to piece together the holistic impact of leveraging these solutions through the lens of Clinical Trial Continuity.