A large global pharma company needed a CTMS strategy to digitize and optimize all processes for planning and running clinical trials. In addition to a new CTMS solution, the client also needed migration of data and alignment of processes between four divisions.
The client needed to align the processes in all four divisions and create a consolidated view of all trial planning and execution activities. They also needed help in vendor selection and implementation.
HERAX created an overall strategy for digitizing the clinical operations together with all four divisions in three months. Then new core processes were created based on best practice and OoO functionality from most CTMS vendors. Vendor selection was based on first a RfI with eight participants, and then four RfP contestants. The vendors demonstrated their proposed solution of the specific user journeys created as a part of the analysis phase for clinical operations specialists, and a preferred vendor was selected. Implementation of the base system took six months, and phased migration of all four divisions, as individual big bang migrations, took an additional six months. It was important not to overload the business with project tasks and training while running studies.
Implementing best practices for Risk-Based Monitoring (RBM) resulted in reduced time spent on monitoring activities and running more trials with the same staff.
HERAX assisted with the migration of old legacy systems, new processes, and training. Analysis and strategy were created in 6 months, together with an agreement for further processes. Vendor selection took four months, and implementation and migration were done (phased approach – 1 division at the time) in less than a year.
All clinical processes for study feasibility and planning, monitoring, study management, reporting, SAE reporting, product supply, and study closure were redone, creating core processes. The training was developed as eLearning for all CTMS areas.
Using the new CTMS enabled the Clinical organization to plan studies faster due to a complete overview of internal resources and access to investigators’ past performance. It helped feasibility and study startup timelines to be much shorter. Among the measurable benefits are:
- Enrollment time improved by 15 – 20% due to improved investigator selection
- RBM introduction has eliminated about 30- 50% of all monitoring visits depending on TA
- Protocol deviation findings have decreased by 20% due to more focus on on-site issues
- Automated status reporting on all trials
- Integration to eTMF and master data for all studies
- Support for system provisioning for other clinical systems (EDC, IVRS, eTMF)