Complex oncology trials are changing the clinical trial paradigm. Old EDC systems simply cannot keep up. A new, innovative EDC system is needed to handle the complexity of trial designs and provide a level of usability and feature-set that has been unseen in the market to date. Protocol First is that EDC system.
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.
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.
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.
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.
Protocol First checks off all the boxes on the EDC checklist. Protocol First goes beyond the requirements, providing features that no other EDC offers out-of-the-box. Protocol First provides the highest level of review and oversight — all standard, with no custom code and no manual processing.
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.
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.
Are you looking at a backlog of queries? If so then it’s time to make a change to an EDC that can handle your complex protocols.
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.