Unlock the power to be your own CRO.

Clinical Research Coordinator Analysis

PK/PD Sample Processing and Storage Logistics

Finding: The protocol (Sections 6.3.1, 6.3.2, 6.3.3) mandates specific and tight timelines for Pharmacokinetic (PK) and Pharmacodynamic (PD - hsCRP, IgE) sample processing: centrifugation within 60 minutes of collection and freezing of plasma/serum aliquots at -70°C (preferred) or -20°C within 120 minutes of collection. This presents a logistical challenge for sites if phlebotomy, processing lab, and required freezers are not co-located or if lab staff have competing priorities, potentially leading to temperature excursions or processing delays that could impact sample integrity. Recommendation: Sites should prospectively evaluate their current laboratory workflow for PK/PD sample processing prior to enrolling the first participant. This evaluation should include:

1. Confirming the consistent availability and close proximity of a calibrated centrifuge and a -70°C freezer (or a dedicated, continuously monitored -20°C freezer if a -70°C freezer is not reliably available or accessible within the timeframe).

2. Conducting a timed "dry run" or detailed mapping of the sample pathway from the point of blood collection to final frozen storage to verify that the 60-minute centrifugation and 120-minute freezing deadlines can be consistently met, even during busy clinic periods.

3. Developing or updating a site-specific Standard Operating Procedure (SOP) or detailed checklist for these time-sensitive samples, clearly designating responsible personnel and trained backup staff.

4. Proactively discussing with the Sponsor or central lab whether brief, temperature-controlled temporary storage (e.g., on cold packs or at 2-8°C) is permissible for processed aliquots immediately prior to transfer to the long-term freezer, should direct access be momentarily challenging, as long as the 120-minute window from collection to freezing is strictly adhered to.

Rationale: Ensures the integrity and viability of critical PK/PD samples, which are essential for key study endpoints. This proactive planning reduces the risk of protocol deviations related to sample handling, minimizes potential queries, and helps sites allocate appropriate resources and personnel effectively for time-sensitive laboratory procedures, ultimately contributing to higher quality data.