Quality Time: Addressing GCP Training With Recent ICH Changes

By Tarra Roshan, Director, Quality Assurance and Compliance, Trifecta

Advances in clinical trials continue to evolve at an exciting pace. Supporting these advances, technology has progressed to address the increased scale, complexity and costs of clinical trials. With these changes in mind, ICH GCP E6 (R2), the largest revision to the ICH GCP guidelines in over twenty years, provides several addendums focused on ensuring reliability of trial results by addressing these advances in clinical trial technology. While many areas can be affected by these changes, the topic of good clinical practices (GCP) investigator training is one Trifecta is focused on helping our clients ensure compliance with the global impact of these changes effective in 2017.

ICH E6 (R2) Compliant GCP Training

Trifecta offers standardized GCP training that can be offered on demand to ensure compliance for your investigators at their convenience, anywhere across the globe. Fully customizable and animated, Trifecta’s GCP training is compliant with ICH E6 (R2) guidelines, making it easy for clients to update their GCP library as well as maintain compliance with the recent changes.

Customized Strategies for Gap Training

In addition, Trifecta partners to help create and execute customized strategies for gap training. To ensure compliance of site staff with new regulation via updating existing training and handle changes/amendments, Trifecta works closely with clients to perform analysis and create strategies specific to client needs.

While industry changes regarding ICH E6 (R2) can be challenging, Trifecta offers solutions that simplify while delivering quality and savings in both time and resources. To start a conversation with one of our experts, please reach out to us at sales@trifectaclinical.com

Tarra Roshan leads Trifecta’s global Quality Assurance and Compliance activities. Ms. Roshan brings more than 23 years of Quality and Regulatory compliance experience in the life sciences industry. Prior to joining Trifecta, Ms. Roshan held positions at Beckman Coulter, Baxter Healthcare, and Braun Medical where she was responsible for numerous quality and compliance management initiatives. Ms. Roshan’s educational background includes an MBA from the University of La Verne and a Bachelor of Science degree from California State University Fullerton.