The sponsor required rapid execution of a pharmacokinetic (PK) study under extremely compressed timelines. The reference product would expire within one month, requiring accelerated ethics approval, contracting, study initiation, recruitment, in-house conduct, PK sampling, and database completion. Midway through execution, the sponsor increased enrollment from 10 to 20 participants, further intensifying operational complexity.
The InoRx SRM Team, operating within SRM at the time, mobilized immediately. Early engagement between clinical operations and medical writing ensured alignment on PK sampling windows, inclusion and exclusion criteria, safety considerations, and sample-processing workflows prior to formal study acceptance. Despite limited in-house staffing and a protocol requiring a 72- hour in-house stay, the team supported expanded enrollment through round-the-clock execution, resulting in zero missed PK time points, minimal deviations, real-time EDC entry, and timely query resolution.
The study was successfully initiated, conducted, and completed within the sponsor’s shortened timeline, enabling use of the reference product before expiry and supporting regulatory submission plans, with strong protocol adherence, timely database completion, and consistent data quality under intense operational pressure.
A Case Study in Accelerated Clinical Execution
Discover how InoRx successfully executed a pharmacokinetic study under critical timelines. Learn how our team overcame operational challenges, ensured data integrity, and supported regulatory submission—all while meeting accelerated deadlines.
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