The study design is the most important component of a successful trial. We’re the first EDC to digitize the Protocol—within a day. This eProtocol becomes the building block for all downstream data collection activities. The system also generates all the necessary artifacts (aka specifications) within one single configuration file. There is full traceability from eProtocol through regulatory submission!
Support all 5 modalities of eSource data acquisition, as described by the FDA, into a single multimodal eCRF — including direct import of data from EHR, with Clinical Pipe.
Protocol First was built from the ground up to meet and exceed the highest regulatory standards required for clinical trials. The platform natively collects and exports in SDTM so you can review and submit data in SDTM, as required by the FDA. Only Protocol First can give you this level of compliance and peace of mind.
Protocol First has expanded its leadership in EHR-to-EDC integration with a new standard application that integrates EHRs with P1 but also now allows for EHR integration into existing EDCs like Rave and other enterprise EDC systems. You can learn more by visiting our Clinical Pipe product website at clinicalpipe.com.
With Protocol First, we want to change the way you think about trial timelines. Our technology makes it possible to set up complex oncology trials in as little as five days, a task that takes up to three months with legacy systems. Once off and running Protocol First provides protocol changes within hours—without the need for data migrations and downtime. You will never miss a key milestone anymore!