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Evolution through innovation.

The driving force behind Protocol First is Innovation.  It is this innovation that creates the features that ultimately lead to the benefits that can handle the complexity of today’s clinical research.  The goal at Protocol First is to build a platform through innovation and technology that will allow sponsors to get their data to the FDA faster, with improved quality and with costs contained.      

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Industry's First EHR to EDC Integration

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.  

 This is Clinical Pipe

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eProtocol Single Point of Truth

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.   

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Treatment Cycles

Branches

Observation

 With P1’s eProtocol, studies can begin on time and begin the right way. Each important aspect of data collection has clinical meaning: Studies can be built within a day and any future changes within hours.  We offer a 72-hour guarantee on any request.  
 

P1 = Zero Custom Code

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Comprehensive Data Acquisition

Support all 5 eSource data acquisition methods into a single multimodal eCRF – including direct import of data from EHR.

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A new level of reports.

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

Built for Compliance

P1 has been built from the ground up to meet and exceed the industry’s toughest standards. The platform has its data in SDTM natively so you can review in SDTM and deliver in SDTM, the way the FDA demands it. Only P1 can give you this level of compliance and peace of mind.

– 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.

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