Design a “real-world ready” protocol.
Are your criteria, endpoints, and comparators the right ones for a trial enrolling today’s patients?
Improve Study Design
“Stress test” your protocol’s eligibility, endpoints, and timeline projections with real-world data on more than 200 million patients.
See how adjusting your protocol’s inclusion and exclusion criteria could change the number of potential trial participants.
Avoid Unnecessary Amendments
The average protocol amendment costs between $72,000 and $500,000 in direct costs alone. Protect your investment with a data-driven approach to optimizing your study design.
Successful Recruitment Begins with the Optimal Protocol Design
Biopharma companies can use real-world data (RWD) internally during the protocol writing process. Protocols are typically written by scientists. Clinical development experts work largely from a scientific perspective, often referencing literature or copying criteria from previous studies in the same or a similar indication. All of these are necessary considerations for any study. Yet, what is often lacking is the patient perspective.
Are the eligibility criteria so restrictive that patients who meet them don’t exist in the real-world? Are there opportunities to make minor modifications that will result in a far more successful operationalization of the study? Find out by requesting a free preliminary evaluation.