P1 upends clinical trial execution

Purpose-built for oncology and complex trials

Merges research and medical encounter data

Transforms trial conduct

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As medical research advances, so do the complexities of clinical trials. Protocol First creates a web-based digital protocol accessible on any device to guide sites through patient encounters.

Protocol Amendments

The Protocol First system has been architected to embrace the changing nature of a site’s progression through multiple amendments independently from other sites. Where staggered releases once threw a wrench in your entire system, Protocol First allows staggered releases across all sites quickly and seamlessly.

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Current Reality:

Protocol amendments translate to intractable complexities, delays and cost overruns, not to mention audit findings.

Schedule of Assessments

All the information contained in the SOA and dispersed throughout the footnotes, the protocol, and associated operations manuals becomes available at the click of a button, at lightning speed, on any device.

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Current Reality:

The SOA captures the protocol complexity—hard-to-read at best, inconsistent at worst.

Trial Branching

Ideally suited for adaptive designs and personalized medicine trials, the Protocol First system offers n-level of “branching” to represent branching options for sub-protocols, conditional visit paths, treatment options, etc. Scheduling and monitoring become a breeze.

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Current Reality:

When technology limits research—legacy eClinical requires custom code to represent branching

Cycles

With a few parameters and within a few hours, the Protocol First system represents the most complex cycle patterns—unleashing trial designers, allowing seamless progressions through the trial, and reducing enrollment delays.

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Current Reality:

When technology can’t keep up—cycle complexity takes weeks to program in legacy eClinical

Guidance

Protocol First provides turn-by-turn guidance through the protocol— for any user, on any device. In real-time and collaboratively, site users are guided through all protocol-mandated procedures.

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Current Reality:

Quality data can only be obtained through consistent procedure administration

Certified Copies

With Protocol First, source data are saved as they become available and attached to the relevant procedure. Available on line, the source data repository allows central monitoring, facilitates safety reviews and keep the site audit-ready at all times.

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Current Reality:

The crux of the problem—disparate source data, produced at different times and stored in different places