As 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.
June 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.
June 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.
December 2-3, 2020 | Virtual
Join Avoca's session: "ICH E6(R3) Review: RBQM Considerations within Annex 2 Applied to Non-Traditional Trials"
October 14-15, 2020 | Virtual
Now in its ninth year, the Avoca Summit focuses on quality and the adoption of innovative technology in the execution of clinical trials.