Protocol First

The ProtocolFirst, or P1, application upends clinical trial execution.

Its purpose-built for oncology and complex trials to merge research and medical encounter data and transform trial conduct.

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.

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.

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.

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.

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.

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.