A delayed CRO startup put a BA/BE study at risk, with only approximately one month remaining before the reference clinical trial material expired. The sponsor needed rapid intervention to recover the timeline and avoid further delays.
InoRx rapidly prioritized four sites and accelerated site activation, patient screening, and recruitment. SRM Hospital increased its enrollment target from 20 to 30 participants to offset delays at other sites, while maintaining continuous 96-hour inpatient coverage, precise PK sampling, same-day EDC entry, and rapid query resolution.
The rescue strategy enabled first patient enrollment within two days of site activation and recruitment completion in approximately 25 days. SRM screened 100 participants and dosed/randomized 80, with zero missed PK sampling timepoints. The study was completed within the remaining shelf life of the reference clinical trial material, protecting the sponsor's critical timeline.
A Case Study in Accelerated Clinical Execution
A bioavailability/bioequivalence (BA/BE) study in an anemic patient population was at risk after the previous CRO was unable to initiate eight planned sites on schedule.
The situation became critical when only approximately one month remained before the reference clinical trial material expired. Continued startup delays could jeopardize completion of the study within the available product shelf life.
The sponsor needed rapid intervention to recover the timeline.