A 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 MoreAugust, 2016 Just because information can be gathered and shared more quickly among stakeholders does not mean that it can identify risk. This article describes the need for pharma to adopt fully-vetted, standardized operational-level time, cost and quality performance metrics as tools for tracking and predicting performance. The proliferation of cloud-based technologies has made it […]
Read MoreApril 7, 2017 The pharma industry agrees that the importance of entering data into an EDC as soon as possible following a subject is paramount. Slow site data entry can impact the credibility and usefulness of centralized monitoring data analytic reports. But MCC survey indicates poor oversight undermines ability to monitor study quality With the […]
Read MoreJune 15, 2020 - CenterWatch
With the International Council on Harmonization (ICH) poised to begin work on another revision to its good clinical practice (GCP) guideline, ICH E6, sites and sponsors have questions about what they can expect from upcoming changes while they still are struggling to interpret requirements placed on them by the previous 2016 revision. See insights provided by Steve Whittaker, Senior Consultant of The Avoca Group.