March 30, 2021 | 1:00 – 2:00pm EDT
ICH E6 (R3) is coming at a time when life science organizations still are struggling to adopt ICH E6 (R2). But should organizations wait until these guidelines are ratified to realize the intended benefits?
Successful performance metrics focus on what drives success across the enterprise. They help answer important questions. They have a purpose. Don’t measure things simply because you can, or that aren’t a concern for your organization. That may sound obvious, but many organizations measure things that simply don’t matter. Just because something is a problem […]
Read MoreSponsors and ECG Core Labs need to effectively manage and track their resources, including people, time, and money, as each has an impact on productivity and efficiency over the course of a clinical trial. This case study demonstrates how Lilly and Quintiles utilized ECG Performance Metrics to have meaningful conversations around performance metrics to […]
Read MoreA clinical-stage biopharmaceutical company requested that Avoca perform an in-depth review and assessment of its Quality Management System (QMS). The project objectives were to identify and document gaps and to provide guidance in the design and development of a comprehensive QMS that would complement the company’s existing QMS. The company also requested that Avoca […]
Read MoreSince the release of ICH (E6) R2 in 2017, clinical research companies have been taking active measures to ensure compliance with its new guidance which, “encourages implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial results.” […]
Read MoreA clinical-stage global biopharmaceutical company with major hubs in the US and Japan requested that Avoca perform an in-depth review and assessment of its Clinical Quality Management System (CQMS) with a special focus on Vendor Oversight, Risk Management, Technology Business Requirements, and Quality Tolerance Limits (QTLs). The project objectives were to identify and document […]
Read MoreBy providing a mid-sized pharmaceutical client with more than a standard mock inspection and having the agility to pivot as the client’s needs changed, Avoca positioned the company for a successful regulatory inspection. Avoca not only delivered clear and actionable findings; it helped the client design and execute a remediation strategy. To download the […]
Read MoreAs the GCP landscape continually evolves, sponsors are encouraged to pursue innovative approaches. Mock Inspections are a critical tool to ensure inspection readiness and a quality control step to confirm that the innovative approaches are being implemented in a regulatorily compliant way. Inspection Readiness needs to keep pace with this philosophy and to be […]
Read More