<img height="1" width="1" style="display:none;" alt="" src="https://dc.ads.linkedin.com/collect/?pid=437588&amp;fmt=gif">



Advanced EDC Built for Oncology

Protocol First is the first EDC that specializes in collecting response data and detecting safety signals


Asset 11

Oncology trials deserve a better EDC.

Complex oncology trials are transforming the clinical trial paradigm, and sadly, old EDC systems cannot keep up. It's time for a new, innovative EDC system capable of orchestrating the complexities of trial designs. It's time to for a whole new level of usability and feature-sets that have been unseen on the market to date. It's time for Protocol First.

Asset 1

Clean data is better data.

When people say they want clean data, they want data that is entered in a timely manner that can be verified against source to ensure its validity. To get better data, you need data that is formatted for analysis.

Protocol First is the only EDC system that delivers your data in a timely manner, ready for analysis. This is what today's complex trials demand.

Asset 2

The two dimensions of success.

One is safety and efficacy and the other is operations. Understanding this perspective, Protocol First was developed to address all key drivers of successful oncology trials from the start. Our suite of powerful benefits elevates the traditional list of features found in other EDC systems, allowing us to deliver speed and accuracy not found with any legacy EDC system.

Asset 3
Asset 7-1
Asset 6-1

The best for both worlds. 

Operational Benefits

Oncology Optimized Build
Real-Time Rest API


Clinical Benefits

Safety Signal Detection
Response Data


Asset 8-1

Safety Signal Detection

This linkage provides traceability between an observation and an adverse event. This is a next generation workflow, available today as part of the standard Protocol First EDC system. The data is exported in industry standard CDISC SDTM for re-usability, ease of analysis and submission.

Asset 2-9


Oncology Optimized Build

Treatment Cycles (Serial and Parallel), Visits, Repeating Assessments, Branching, and Sub Protocol. These additional concepts are reusable objects that are accessed with lines of configurations in the build process. This allows for rapid build times and closer mapping to what’s described in the paper protocol.


Protocol First EDC provides tools to allow clinical monitoring and data management teams to perform their oversight work. Automated reports and workflows are optimized for increased team efficiency and cleaner data.



Protocol First EDC provides tools to allow clinical monitoring and data management teams to perform their oversight work. Automated reports and workflows are optimized for increased team efficiency and cleaner data.

Real-Time Rest API

An enterprise-grade API allows EDC systems to integrate with enterprise workflows. Protocol First EDC allows for a CDISC ODM data transfer API so that operational and clinical data can be imported and exported to and from data lakes, 3rd party data sources, reporting engines, etc.

Asset 9-1

Full Featured EDC

  • API for defining custom reports
  • Library of observations, assessments, and edit checks with full versioning
  • Automatic calendar based inclusive of visit windows
  • Linking workflow of Observation, Intervention, and Event

  • 99.95% SLA for system uptime
  • Real-time export of clinical data (SAS on-demand) with zero wait.
  • Dynamic visit schedule based on sub-protocol, branching, and treatment cycles
  • Auto query engine with custom functions
Asset 10-1

Why it's time for Protocol First.


Built for way more than Oncology

Protocol First was built to handle the most complex oncology trials, but it can also scale and handle any clinical trial design. Our feature-rich platform can be leveraged and scaled to bring efficiencies and cost savings to any trial, big or small. Please contact us to learn how Protocol First can help your clinical trial.

Stop speeding without a seatbelt

Is your old EDC getting you in trouble?  Chances are, you aren’t getting your safety data right and you aren’t getting your data ready for analysis anywhere near fast enough.  Are you able to flag AEs in real-time? Not only does this have consequences for your trial, but it also adds time, money and unnecessary effort.


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.