Unlock the power to be your own CRO.

Clinical Research Coordinator Analysis

Cycle 1 Day 1 PK Sampling Logistics

Finding: The intensive PK sampling schedule on Cycle 1 Day 1 (C1D1), particularly the 24-hour post-dose sample, presents a significant logistical challenge and participant burden. The protocol (Section 1.3, SoA footnote 'f'; Section 8.2.1.1) specifies multiple PK draws post-batiraxcept infusion, culminating in a 24-hour sample. While flexibility is offered (participant return to clinic or home health nurse collection), coordinating a return visit for a single blood draw the day after a lengthy C1D1 (which includes a 60-minute IV infusion, pre-dose procedures, and several earlier PK draws) can be demanding for participants. Reliance on home health services requires pre-established agreements, training, and logistical processes (e.g., kit provision, sample transport) that may not be universally available or seamlessly integrated at all sites from Day 1 of enrollment. Recommendation: During site feasibility assessment and prior to site initiation, sites should proactively evaluate and confirm their specific operational plan for the C1D1 24-hour PK sample. This plan should be documented in site-specific work instructions or SOPs and include:

1. A clear decision pathway for whether participants will be asked to return to the clinic or if home health services will be utilized, considering participant preference and site capabilities.

2. If home health is the preferred/required option, confirmation of contractual agreements, specific training for home health nurses on protocol requirements (sample collection, handling, documentation), and robust kit/supply chain logistics *before* the first participant is consented.

3. Explicit communication to potential participants during the informed consent process regarding the full time commitment for C1D1 procedures, including the plan and expectations for the 24-hour PK sample collection, to ensure full understanding and manage expectations.

4. If participants are to return to the clinic, ensure that the C1D1 24-hour PK visit (effectively a C1D2 visit) is scheduled concurrently with other C1D1 appointments to secure participant commitment and clinic resources.

Rationale: Proactive and detailed planning for the C1D1 24-hour PK sample collection minimizes participant burden and potential for missed visits, reduces the risk of deviations from critical PK sampling timepoints, ensures sample integrity through proper handling regardless of collection setting, and prevents last-minute coordination issues that could impact data quality and operational efficiency.