ExL’s 4th European Clinical Quality Risk Management Forum
24–25 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."
News & Industry-wide Events
Webinar: When Navigating Risk in Clinical Trials, It’s Best to Mind Your CTQs and QTLs
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).
Webinar: Ensuring Quality and Risk Mitigation with Proactive Planning in Clinical Trials
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.
Webinar: Do You Have an Effective Oversight Plan of Your CRO-Vendor? How Are You Measuring It? ICH E6 R2 Requirements for Vendor Oversight
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 […]
News Release: New Report Introduces Benchmarks on Clinical Trials Vendor Qualification Process
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Read MoreWebinar: RBQM – The AQC’s Risk-Based Monitoring Framework and Monitoring Plans Consistent with New FDA Draft Guidance
December 11, 2019 | 11:00am-12:00pm EST
RBQM: The AQC’s Risk-Based Monitoring Framework and Monitoring Plans Consistent with New FDA Draft Guidance
Virtual Clinical Trials Conference
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 MoreNews Release: New Study from Tufts Center for the Study of Drug Development Establishes Benchmarks for Vendor Qualification Process
November 14, 2019 - Tufts CSDD Study Identifies Opportunities for Drug Sponsors to Optimize Vendor Selection
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