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 onto existing protocols. You can learn more at Clinical Pipe, a Protocol First sister company.
The key to starting any clinical study is to get the Protocol right and too often legacy EDC systems get it wrong. Getting it wrong in the beginning makes everything else down the line harder, longer and more expensive.
P1’s eProtocol is like the Rosetta stone of clinical trials–turning the protocol into organized metadata.
P1 = Zero Custom Code
With a new evolution of CDMS platform comes a new level of reporting and data review. Rapid SDV via remote monitoring and near-Realtime Data review and visualization
– 21 CFR Part 11
– 45 CFR Part 164.C (HIPAA)
– Predicate GCP/ICH including latest eSource, EHR guidance, E6 R2 and June 2017 Part 11 draft guidance
PHI access is strictly limited in a role-based access to the platform that meets ICH E6(R2) 5.15.2 requirements. Production environments are fully located within the EU. The P1 platform has had multiple successful regulatory audits of the platform. The P1 platform has been built to handle the most complex clinical research programs and scale to an infinite number of protocols but can also handle small biotech startups needs.