SimpleCTMS Case Study • Pearl Therapeutics
Case Study: SimpleCTMS adoption and implementation for Pearl Therapeutics, a mid-stage biotech company with an established EDC and IWRS e-clinical vendor, extended clinical field team, and specific upper management reporting needs.
Scope of Project
Pearl Therapeutics’ program consists of four global Phase II studies conducted in parallel internationally. The timelines for SimpleCTMS adoption closely followed the study timelines from study startup to closeout, including a short, aggressive window to deploy, setup and adopt the CTMS.
Challenges For Pearl Therapeutics
Pearl Therapeutics was seeking a study management solution to increase efficiency of planning and tracking tasks and communication, and improve transparency into study progress.
Included among the CTMS requirements:
- Information sharing and maximizing vendor strengths without duplicating efforts was a critical component to the program success.
- CRA calendaring and site visit report progress was needed for resource planning and site trending.
- Integration with critical components of IWRS and EDC were required to provide a snapshot of the critical screening and enrollment efforts by study. country, site, subject, and visit.
- Providing a mechanism to track target enrollment versus actual enrollment planning was needed for startup and ongoing site management.
- Robust yet flexible exports, dashboards, and reporting tools were needed to satisfy management needs.
Finally, the CTMS needed to be flexible enough to adapt to client-specific needs in a fast-paced and dynamic clinical study environment.
SimpleCTMS was chosen to address Pearl’s study management challenges. The SimpleCTMS product and client support team have met and exceeded the client’s needs in several specific ways:
- With a quick implementation and setup, and streamlined training of SimpleCTMS, the customer was able to quickly build an extensive site and team member contacts database. Site and team members were easily associated with multiple studies to mitigate duplicate data entry and to create standard site and team rosters.
- Key milestones and targets were added to drive site and country planning tasks with ease. Once complete, milestone definitions were copied across multiple studies to eliminate duplicate data entry.
- Detailed screening and enrollment planning efforts were managed by country and site using the standard enrollment planning functionality within SimpleCTMS.
- CRAs were able to immediately create calendar events in SimpleCTMS by CRA, site, visit type, and duration and track the status of development and completion of associated visit reports. Comprehensive calendar entries were viewable by vendor, country and CRA name for resource planning within and across studies.
- The EDC and IWRS integration efforts were easily mapped using the standard protocol visit definitions functionality. Projected subject visits were displayed and actual subject visits were integrated for CRA and site management oversight.
- Integrated EDC and IWRS data feeds provided powerful dashboard visualizations and reports to meet daily team member needs and upper management trending.
- A “sandbox” study was setup by the SimpleCTMS client support team. This fully built-out, sample study proved to be a valuable resource for the client users, not only for training, but also to allow ongoing reference and experimentation of the CTMS functionality.
- The SimpleCTMS dashboards were refined to provide executive-level roll up of recruitment progress and trending, including visualizations for screening and randomization targets versus actuals.
"The SimpleCTMS team continues to meet and exceed our needs. Their willingness, flexibility and expertise have provided our organization with an easy to use solution that effectively ties together our existing best-in-class e-clinical solutions. The integration efforts allow our study team to easily track, trend and oversee the site activities without duplicating efforts across teams or vendor systems. We are extremely pleased with the SimpleCTMS customer support and find the client managers and technical team to be very responsive and knowledgeable. We highly recommend SimpleCTMS!"
Chad Orevillo, MPH
Vice President and Head of Clinical Operations
Pearl Therapeutics, Inc.