March 6, 2020
Washington, DC – The Association of Clinical Research Professionals (ACRP) and The Avoca Group will jointly recognize leading Sponsors and CROs at the ACRP Awards & Recognition Ceremony on Friday, May 1, during the ACRP 2020 annual conference in Seattle, Washington.
March 4, 2020 – Contract Pharma – Jay A. Turpen, Senior Consultant, The Avoca Group – Key first steps to vendor risk management. Are your company’s clinical development vendor qualification (VQ) activities a “Check-The-Box” exercise because someone said that regulators expect it? Or are your VQ activities a comprehensive first step in managing the risk […]
Read More24–25 February 2020 | London
Join Avoca's session, "Define the Framework and Critical Elements of an Effective Oversight Plan: ICH E6 (R2) Requirements for Vendor Oversight."
February 18, 2020 | 11:00am – 12:00pm EST
In this webinar, Crissy MacDonald, Executive Director, Client Delivery, The Avoca Group, will discuss the Quality Tolerance Limit requirements of ICH E6 (R2) and the intersect of Section 3 of ICH E8 (R1), where specific focus is given to proactive quality-by-design in clinical trials, including identifying and managing critical-to-quality factors (CTQs).
February 11, 2020 | 1:00-2:00 pm EST
Join Avoca and Oracle Health Sciences to identify what's needed to mitigate risk and ensure regulatory compliance and audit-readiness in clinical trials.
January 29, 2020 | 11:00am – 12:00pm EST
Sponsor Responsibilities for Quality Management (Section 5.0 of ICH E6 (R2)) requires that Sponsors oversee trial-related duties and functions, including those that are subcontracted by CROs (5.2.2). Quality assurance has changed from assurance of conformity to the assurance that process performance and quality are managed over […]
January 9, 2020 – GLOBE NEWSWIRE PRINCETON, NJ – A new report from Tufts Center for the Study of Drug Development establishes benchmarks for the vendor qualification process, a critical element of clinical trial set up and execution. According to its November/December Impact Report, the process volume and complexity of the vendor qualification process creates […]
Read MoreDecember 11, 2019 | 11:00am-12:00pm EST
RBQM: The AQC’s Risk-Based Monitoring Framework and Monitoring Plans Consistent with New FDA Draft Guidance