Enrollment delay is your biggest timeline risk. Here is the fix.
Enrollment failure is the single most common reason trials miss timelines. The root cause at most sites is not patient availability, it is pre-screening throughput. Enrollvue targets that specific step.
What the enrollment timeline looks like
Manual pre-screening
- Coordinator pulls charts one at a time against each criterion
- 3-4 months to fully screen a 200-patient list at a typical site
- Criteria interpreted inconsistently across coordinators and across sites
- Sponsor has no visibility into site pre-screening progress until it is too late
3-4 months per site, before FPI
With Enrollvue
- EHR query runs all criteria simultaneously against the full patient population
- Ranked eligibility list delivered within hours of query completion
- Same criterion logic applied identically to every patient, every site
- Protocol-level candidate rollup available for sponsor review in real time
Weeks, not months, to candidate list
Your milestone
- Sites complete pre-screening before the FPI milestone, not after
- Protocol amendments are driven by efficacy data or scientific rationale, not enrollment failure
- Enrollment shortfalls identified with enough lead time to activate a contingency site
- Sponsor reporting reflects accurate, current pipeline data
FPI milestone protected
Protocol complexity is not a blocker
Protocol complexity has increased steadily for over a decade. Average I/E criterion count per Phase 3 protocol is significantly higher than it was in 2010. Each additional criterion adds review time per patient chart, multiplied across every site. The more complex the protocol, the larger the gap between manual review capacity and what a systematic EHR query can do.
Enrollvue does not simplify your protocol. It processes the protocol as written, including temporal constraints, compound AND/OR/NOT logic, and lab value windows. Coordinators review the output of that evaluation, not the raw source charts. The protocol's complexity remains yours to manage; the pre-screening throughput is what changes.