Fully Integrated And Validated ePRO/EDC Solution
Background | Post Market Research For an FDA Approved Drug
A pharmaceutical company develops and commercializes innovative targeted oncology treatments to address major unmet medical needs and advance cancer care. Founded in 2006 and headquartered in Portland, Oregon, this company is pioneering research in the field with several drugs in the pipeline, one of which is already FDA approved.
Challenge | A Validated ePRO To Work Seamlessly With Their EDC
The Pharmaceutical company’s FDA approved drug is a prescription medicine that is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines.
As part of the their post marketing activities they needed a validated ePRO (Patient Reported Outcome) solution to replace the one they were currently using through their data management vendor as it was not validated. ePRO allows patients to fill out their case report forms electronically, offering the following benefits:
- Increases the rate of compliance as opposed to requiring patients to attend in person
- Limits discrepancies linked to paper-based data entry
- Reduces the cost associated with mailing out forms
This corporation sought out ClinCapture to integrate its validated ePRO system to its current EDC system so that patient entered data would be implemented directly in to the case report forms, thus saving the time and mistakes associated with re-entering the data in a second EDC system.
Solution | Adopting ClinCapture, Coupled With Its ePRO Solution
After seeing the power of ClinCapture’s ePRO solution, a key feature of its EDC system, as well as realizing the ease with which they could migrate their study, the company chose to adopt both ClinCapture’s ePRO solution as well as the EDC system itself.
ClinCapture’s intuitive and user-centered ePRO module allows seamless patient data collection directly in to the system and is remarkably simple to use. It has been designed to maximize the ease in which patients can report their observations and contains dynamic forms that reduce data entry time. The reported data is automatically and securely imported from the ePRO system directly into ClinCapture. If a patient doesn’t fill the diary as expected, ClinCapture follows up with an automated email reminder to the patient.
ClinCapture worked closely with this company’s data management vendor Cancer InCITe in order to transition the team from their current EDC system to ClinCapture. “With just one day of hands-on training with ClinCapture , I was able to train all of the sites. It really was very fast for them to adopt,” states Laura Ferrise, Director of Data Management at Cancer InCITe. Cancer InCITe already had their databases built which ClinCapture was able to seamlessly migrate to ClinCapture as well as customize the integration of the EDC and ePRO to their exact specifications.
The corporation’s site-level feedback ranked ClinCapture, and its ePRO, with a product rating of 5/5 and just as impressive, feedback on the ClinCapture team also garnered a rating of 5/5.