The New Operating System for Clinical Research

Protocol First has been built from the ground up to be the solution for today’s complex trials and complex clinical research programs. P1 addresses trial complexity using a proprietary eProtocol format to model the most complex protocols whether single trial or combination trials (basket/master or umbrella/platform protocols). To handle data-intensive trials in the most complex environments, P1 also leverages industry standards for import (EHR FHIR / CDISC LAB and ODM) and export (CDISC SDTM).

 

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eProtocol

Set up and Changes only takes days.  Get operational details of the protocol available right in your EDC system, all the time. 

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EHR Connector

EHR to EDC integration out of the box.  One Click in EHR to transfer data.

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Reports

Dynamic and Automated reports to keep work flowing avoiding backlogs.   Allowing for full Audit and remote SDV. 

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Compliance

GDPR, Part/Annex 11, HIPAA - we have you covered with our SOPs and Policies that address compliance needs.

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It's time to get P1 working for you.
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P1 Benefits

 

Rapid Study Build

No More Surprises

No Missed FPI

Highly Predictable

Real-Time Operational Alerts

72hr Post Prod Changes
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P1 Features

 

On-Demand SaaS

Go Live in 5-10 Days

45 CFR Part 154.c (HIPPA)

72-Hour Turnaround

21 CFR Part 11

SDTM Native

Rapid SDV via Remote Monitoring

Near Realtime Review + Viz

EHR Data Acquisition
Code

Zero Custom Code

The problem with your old EDC system is that it is not a true on-demand SaaS, cloud-based platform. They all require custom code. It’s this custom code that makes you miss your timelines and delays amendments. Protocol First requires no custom code and is fully cloud-based.

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2855 Telegraph Ave, Suite 300
Berkeley CA 94705
510.345.4100
info@protocolfirst.com

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