Avoca Quality Consortium COVID-19 Rapid Response Working Group
The Avoca Quality Consortium’s COVID-19 Rapid Response Working Group (RRWG) was created to enable the continuity of clinical trials with strategies and practical support, ensuring that there is a focus on patient safety, data integrity, and regulatory compliance as the COVID-19 situation evolves.
Consisting of representation from our 120+ AQC Member companies – the group explores how organizations are implementing plans for insourced and outsourced clinical trial portfolios in light of COVID-19.
Over 9 weeks, 34 executives from 26 biotech, biopharma, CRO, and site AQC Member companies gathered to discuss different topics relevant to COVID-19. AQC Members have access to the weekly webinar slides along with detailed Executive Summaries of the session in the AQC Knowledge Center to support their real-time decision making as they navigate COVID-19 and the impact on clinical trial execution. Members and non-Members can view weekly session highlights below.
RRWG Session Topics:
- March 26: Current State of Site Monitoring in the Age of COVID-19 [Read meeting highlights]
- April 2: Expediting Protocol Amendments in the Age of COVID-19 [Read meeting highlights]
- April 9: COVID-19 Implications for Documentation and Management of TMF/eTMF/eISF and Maintaining Inspection Readiness [Read meeting highlights]
- April 16: The Use of Technologies/Tools to Support Patient Access and Safety Concerns Arising from COVID-19 (e.g., Telemedicine, IP Home Delivery, Home Nursing, eConsent, etc.) [Read meeting highlights]
- April 23: How to Adapt Clinical Studies That Must Continue Treatment and/or Recruitment Because of Limited Standard-of-Care Options [Read meeting highlights]
- April 30: Taking a Deeper Dive into Successful Approaches for SDR/SDV During Times When There is Inability to be On Site [Read meeting highlights]
- May 7: Determining Strategies and Criteria for Safely Restarting Current Trials and Starting New Trials in the “New” Normal [Read meeting highlights]
- May 14: Open Mic Session: Your Questions Answered [Read meeting highlights]
- May 21: How to Use Strategies Implemented for COVID-19 Trials and Apply Them to Future Clinical Programs to Enable Faster Start-up and Execution
If you are already a Member of the AQC, for information about joining the COVID-19 Rapid Response Working Group, please contact Caryn Laermer, Caryn.Laermer@theavocagroup.com.
The Avoca Group’s COVID-19 Consulting Service provides assessment, development, and modification support for critical decision-making, storyboarding, and documentation of processes and approaches in response to the COVID-19 disruption.
Our consulting team is comprised of Subject Matter Experts in Clinical Development and Quality Assurance and can help you assess and implement your organization’s response to COVID-19 to ensure patient safety and data integrity.