Product: BSI CTMS | Industry: Life Science
Curadel Surgical Innovations, Inc. (CSI; Boston, MA, USA), a mid-sized medtech manufacturer, needed a clinical trial management system (CTMS) with an integrated eTMF that could be rapidly adopted to conduct a new series of global clinical trials spanning two continents.
The CTMS had to fulfill these criteria:
- Fully compliant with both US FDA and EU regulations
- Easy onboarding and use for trial managers and CRAs, both internal and external
- A “one-stop” platform for clinical studies, incorporating an eTMF and eMVR (electronic monitor visit reporting system)
- Highly customizable to existing processes
- A responsive and easily accessible support team
- Smart integration with their current EDC
- Easily validated by the company’s QMS (quality management system)
- A solution that provides a rapid ROI
CSI partnered with BSI Life Sciences to adopt an ICH GCP- and 21 CFR Part 11-compliant CTMS with an integrated eTMF and eMVR. CSI came into the onboarding process motivated to rapidly implement BSI’s CTMS, with a small dedicated team and QMS in place. The onboarding process was completed in five weeks, from an initial go-live and the adoption of BSI’s proven standards, configurations, and builtin study templates for a high immediate ROI.
CSI received two fully validated CTMS environments, validation and production, and completed an integrated three-day virtual training. BSI’s API integration also enabledCSI to integrate with their current EDC solution. Additionally, BSI provided a 4-week Hypercare program to assist CSI for ongoing maintenance after Go-Live. The partnership with BSI also opens CSI up to joining a network of like-minded organizations looking to run clinical trials safely and efficiently.
Fully validated software saves time and effort, so you can focus on what you do best. Choose to work with a CTMS provider that travels with you throughout your trial. Find out more at bsi-lifesciences.com/solutions.