Client Success Story
Curadel Surgical Innovations
Onboarding a combined CTMS and eTMF in 5 weeks
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
The Results
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.
The Takeaway
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.
