A leading global pharma company in Europe was looking to digitize its data collection processes in all trials. Their current paper-based processes were cumbersome, required too many resources, and prolonged the time necessary for database lock and access to the clinical results.
The client wanted to move from 100% paper CRFs to 100% EDC for new trials, with the data integrated into their Clinical Data Management System for creation of raw SDTM analysis files.
Vendor selection, updated processes, and implementation success
With assistance from HERAX, a set of Use Cases and Requirements were created to evaluate a series of EDC vendors. HERAX’s vendor selection approach ensures an objective evaluation of the vendors’ functionality against the use cases and additional six parameters (e.g., Implementation plan, price, strategic fit to clinical processes, and IT architecture).
Three vendors demonstrated and were scored, each showing how to set up and report from a representative study. Based on this, one vendor was selected.
In parallel, new processes were developed based on HERAX’ process analysis approach and knowledge of best class clinical operations. New SOPs were written. The new processes were aligned between data management (eCRF design and data cleaning) and biostatistics (data analysis) to ensure the EDC’s output could be loaded directly into the CDMS and analyzed.
Managing the organization’s organizational impact was also handled by HERAX as part of the project, together with key clinical staff, ensuring everyone was aligned and trained in time for the go-live of the new system.
The implementation from idea to first study designed after go-live was ten months.
After the EDC implementation, the client realized multiple benefits. Manual work handling papers were replaced with work focused on the clinical data and supporting a fast enrolment of patients and data reporting.
Some of the other benefits were:
- Patient enrolment and follow-up with sites improved with 80%
- Time from LPLV to database lock decreased to 3 weeks
- More than 90% reduction in CRF errors due to automatic checking
- Clinical data is received continuously and approved daily
- Monitoring effort on source data verification reduced with more than 80%
- Data management and biostatistics have saved more than 80% of effort on handling and cleaning data before getting ready for database closure
- Paper handling and printing costs have naturally been eliminated