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.
February 11, 2020 | 11:00am – 12:00pm EST
Held the second Tuesday of every month and open to the industry, this Webinar offers a live demonstration of the AQC Knowledge Center. No registration is required.
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RBQM: The AQC’s Risk-Based Monitoring Framework and Monitoring Plans Consistent with New FDA Draft Guidance
December 2-3, 2019 | Sonesta Hotel | Philadelphia, PA Virtual clinical trials bring the clinical trial experience to the patient. Through these VCTs, companies are expected to reduce trial costs and increase patient enrollment and participation. There are new technologies that make these trials easier to conduct and with the patient demand for more flexibility in their participation, this new way of doing business will only continue to expand for the industry. […]
Read MoreNovember 14, 2019 - Tufts CSDD Study Identifies Opportunities for Drug Sponsors to Optimize Vendor Selection
Read MoreNovember 2019 In the Spotlight article published November 2019 by International Clinical Trials, Patricia (Patty) Leuchten, Founder and CEO of The Avoca Group, reflects on the challenges associated with managing risks and designing quality into clinical trials; the work the Avoca Quality Consortium® has done to bring together industry experts from pharma, biotech, and CROs […]
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