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Clinical Research Coordinator Analysis

Day 1 / Day 2 Pharmacokinetic (PK) Sample Collection

Finding: The protocol (Section 6.8.1.1, page 63) mandates an intensive PK sampling schedule on Day 1 (pre-dose, 4-hour post-dose, 8-hour post-dose) followed by a required return visit on Day 2 (target 24 hours ± 2 hours post-Day 1 dose) specifically for another PK sample. This two-day commitment, immediately following randomization and first investigational product administration, presents a considerable logistical challenge for site staff in terms of precise scheduling and resource allocation, and a significant time burden for participants at the very outset of their trial participation. Recommendation: Sites should develop a dedicated "Initial PK Visit Workflow." During the informed consent process, explicitly detail the Day 1 and Day 2 PK visit requirements, emphasizing the short turnaround and importance of the 24-hour sample. When scheduling the Day 1 (Baseline/Randomization) visit, concurrently schedule the Day 2 (24-hour PK) appointment. Prepare all PK kits for both days in advance. Designate specific staff responsibilities for managing the timed events on Day 1 to ensure smooth flow. Aim to make the Day 2 visit as brief as possible (e.g., "express PK draw only") to minimize participant inconvenience. Rationale: This proactive planning and transparent communication will enhance participant understanding and adherence to the demanding initial PK schedule, critically reducing the risk of missed samples vital for pharmacokinetic analysis. It will also streamline clinic operations, manage participant expectations effectively, and contribute to higher quality data collection from the start of the treatment period.