COVID-19 Support and Services for Your Clinical Trials
Avoca is dedicated to helping navigate clinical trial continuity by bringing together the collective intelligence of our 160+ Avoca Quality Consortium Member companies and providing deep subject matter expertise in clinical operations and quality to our consulting clients.
AQC COVID-19 Rapid Response Working Group Avoca has formed a COVID-19 Rapid Response Working Group within the Avoca Quality Consortium. The purpose is to facilitate cross-industry collaboration and to support Members’ real-time decision making as we navigate COVID-19 and the impact on clinical trial execution. Following each weekly working session, Members can access the Executive Summary with strategies and practical support for the continuity of your clinical trials. Non-Members can view meeting highlights. |
A Letter From our CEO – Patty Leuchten An update on how we are addressing the needs of Avoca’s clients and Quality Consortium Members, and the companies that we are working with as part of the Diligent® Qualification Platform, given the extraordinary circumstances that we face with COVID-19. |
Avoca Consulting & Subject Matter Experts Avoca has a team of Subject Matter Experts that cover diverse areas, such as Risk Identification and Mitigation, Inspection Preparedness, Quality Management, Oversight, Qualification, and more. We are working with our consulting clients as a virtual extension of their clinical teams to ensure patient safety, data integrity, and compliance with regulations so that post-COVID-19, all changes to processes and procedures are documented and each of our clients is prepared to be inspected by regulatory authorities. |
Avoca Technology The Diligent® Qualification Platform and eLuminate™ eLearning Platform are available to facilitate remote clinical service provider qualification and distance learning, respectively. |
AQC Member Resource – Aha! Community Platform The AQC is a pre-competitive collaborative comprised of over 120 diverse Member organizations. AQC has an abundance of resources available to support our Members during the COVID-19 pandemic including our online community, Aha! that facilitates virtual communication. In addition to asking questions to peers and our SME’s, individuals, through Aha!, can share strategies for being proactive as the situation with COVID-19 evolves. |
AQC Member Resource – Knowledge Center Full access to COVID-19 Rapid Response Working Group materials–including slides and executive summaries–are accessible to AQC Members. |
Rapid Response Working Group Session Highlights:
Brief synopses of the weekly AQC COVID-19 Rapid Response Working Group sessions are posted below as they become available. AQC Members, visit the Knowledge Center to access detailed executive summaries.
Session 1 – March 26, 2020 In the inaugural meeting of the Rapid Response Working Group, 120 AQC Members representing over 70 Member companies gathered to discuss challenges, lessons learned, and promising solutions to navigate the waters of Site Monitoring. Senior leaders from large pharma, biotech, site networks, and CROs shared their experiences. |
Session 2 – April 2, 2020 In the second session, AQC Members gathered to discuss the specific challenges, lessons learned, and promising solutions to navigate the waters of Expediting Protocol Amendments. Based on the discussion, it appears that companies are currently working to limit protocol amendments and manage the process through documented mitigation plans, contingency plans, and deviations where possible. |
Session 3 – April 9, 2020 In the third session, AQC Members discussed the Implications for Documentation and Management of Trial Master Files and Investigator Site Files and Maintaining Inspection Readiness. Based on the discussion, both site and sponsor inspections are continuing to be requested, while there have been delays and postponements. |
Session 4 – April 16, 2020 In the fourth session, AQC Members discussed The Use of Technologies/Tools to Support Patient Access and Safety Concerns Arising from COVID-19. The session focused on the following capabilities: Telemedicine, eConsent, eSource, IP Home Delivery, and Home Health Nursing. |
Session 5 – April 23, 2020 In the fifth session, AQC Members discussed How to Adapt Clinical Studies That Must Continue Treatment and/or Recruitment Because of Limited Standard‐of‐Care Options. The approach to this topic is greatly influenced by therapeutic area and whether standard‐of‐care options are available. |
Session 6 – April 30, 2020 In the sixth session, AQC Members gathered to Take a Deeper Dive into Successful Approaches to SDR/SDV During Times When There is Inability to be On-Site. Speakers discussed the strategy and plans for remote monitoring and how this has evolved as regulatory guidance has evolved. |
Session 7 – May 7, 2020 In the seventh session, AQC Members gathered to Determine Strategies and Criteria for Safely Restarting Current Trials and Starting New Trials in the “New” Normal. The speakers shared their strategies for developing and executing on re‐entry plans as sites begin coming back online. |
Session 8 – May 14, 2020 In the eighth session, AQC Members gathered for an Open Mic to address questions related to COVID-19 and how companies manage issues related to maintaining patient safety, data integrity, and regulatory compliance. The speakers shared strategies for clinical trial continuity during the pandemic. |
Session 9 – May 21, 2020 In the ninth and final session, AQC Members gathered for a panel discussion with senior leaders on How to Use Strategies Implemented for COVID-19 Trials and Apply Them to Future Clinical Programs to Enable Faster Start-up and Execution. The speakers shared strategies on developing medicines for COVID-19 treatment. |