THE NEW OPERATING SYSTEM FOR CLINICAL RESEARCH
P1 IS THE NEXT GENERATION CLINICAL TRIAL EXECUTION SOFTWARE PLATFORM, PURPOSE-BUILT FOR THE COMPLEX TRIALS OF PHARMACOGENETICS AND IMMUNO-THERAPY.
The FDA Cometh
The FDA demands that you deliver your data in SDTM, and FDA reviewers “suggest” that you review your data in SDTM during the course of the trial. FDA and ICH require close control of source data, and encourage eSource and EHR data acquisition. Only the innovation of P1 will future proof your data and operations to what the regulators demand.
World's first EHR Data Acquisition
Industry first data acquired from EHR through Protocol First directly into SDTM. Bye-Bye SDV. Hello 100% consistent data!
GIVE YOUR PATIENTS THE GIFT OF TIME.
Pharmacogenetics and immuno-therapy are revolutionizing clinical research at an unprecedented speed--in particular in oncology. New research requires complex yet agile trial designs, and demands fast access to ever larger quantities of data for review and visualization.
Making your EDC a CDMS system.
The Protocol First platform is a Next-Gen EDC / CDMS; an end-to-end Clinical Trial Execution System designed from the ground up for today’s complex, oncology and precision medicine trials; whether single trials or within a Master/Umbrella/Platform program. Protocol First exports in real-time to SDTM and acquires data directly from EHR systems through FHIR.

Dinosaur EDC holding you back?

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There is a big problem with current clinical research platforms and EDC. These 15-year old platforms were never built for today’s complex oncology and immunotherapy trials, they were never built to acquire EHR data natively and they were never built to export to SDTM natively; let alone without a line of custom code!

Sponsors and CROs have internalized those deficiencies and inefficiencies.  They actually believe that it takes weeks to develop a glorified data collection instrument tailored to a specific trial.  That is not the case!  Existing tools can work but it’s taking too much money and consuming far too much time.

It’s time to make a change. Ditch that dinosaur and start hitting timelines and delivering your data the right way.  If you can’t ditch…at least hitch your EDC to P1. 

P1 can drive your EDC schedule of visits via API calls, as well as collect EHR data to integrate on the back end.  At least, this will help transition out of your current systems.

Introducing P1

The Protocol First platform is a Next-Gen EDC / CDMS; an end-to-end Clinical Trial Execution Software Platform designed from the ground up for today’s complex, oncology and precision medicine trials; whether single trials or within a Master/Umbrella/Platform programv.  Protocol First exports in real-time to SDTM and acquires data directly from EHR systems through FHIR.

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EHR Data Acquisition

Industry first data acquired from EHR through FHIR and P1 directly to SDTM.

eProtocol

P1’s proprietary eProtocol is the single point of truth to get your trials right.

Full Platform

Single solution from site user to submission-ready data.

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Track record.

Selected by the Beat AML Program

Protocol First was selected to support one of today’s most complex oncology programs: The Beat AML program. Everyday, world-class sponsors, CROs and clinical sites leverage Protocol First for better data, faster with reduced site burden and remote monitoring.

The benefits of innovation.

Remote Monitoring

By creating certified copies of source and electronic site logs, a central monitor can review data on an ongoing basis without having to be onsite.

No More Missed FPI

We allow for rapid study builds where you can go live in less than 2 weeks.

Highly Predictable, High Quality

Our eProtocol development process from the paper protocol can model a protocol of any complexity.

Analysis-Ready Reports

Our real-time SDTM export will allow your data management and biostats group access to data in a FDA/PMDA submission-ready format to run interim (DLT, DSMB, etc.) analysis.

Side-by-Side Amendments

Our versioning system goes down to the level of detail needed so that subjects and sites can be on the right amendment at the right time as their IRB approvals have stated.

Reduced Data Entry Time

The site can directly pull data electronically from their EHR system using the HL7 FHIR standard into their procedures.

Better Data Consistency

All complex edit checks are run asynchronously from the EDC system.  This allows true enterprise grade, TA-specific data validation checks that are not constrained by run-time performance and are no longer on the critical EDC development path.

Find Safety Events in Data

Our realtime potential clinical significance checks will find values that meet CTCAE (or other) criteria during data entry or acquisition.

No More Delayed Amendment Roll Outs

From adding an observation to adding a treatment cycle, amendments in hours.

Time is of the essence.

P1 offers time-to-market benefits that are orders of magnitude better than current EDC platforms. Deploying studies via P1’s eProtocol happens in days, even the industry’s most complex ones.  In fact, we offer a 72-hour guarantee for any request, no matter the size or complexity of the protocol you are implementing. We have delivered the most complex oncology protocols within hours, when existing “market-leading” tools require weeks of design, build and validation with ever sliding timelines. Your patients deserve the gift of time that P1 offers!

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The FDA demands that you deliver your data in SDTM, and now the FDA wants you to review your data in SDTM. It’s only matter of time before the FDA demands you to review in SDTM. Now is the time to ditch that old clinical platform that cannot deliver what the FDA wants. Only the innovation of P1 will future-proof your data and operations to what the FDA may bring next.

Get in touch

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