How Dynamic Resupply Changes Drug Accountability and Waste in Clinical Trials

An Applied Clinical Trials article works through a simple example: a trial with 100 sites, two treatment groups in blocks of four, and six dispensing visits. Shipping each site a full block for every visit up front means 2,400 kits before the first patient is randomised. Starting each site with one kit per arm and resupplying as patients enrol means 200 (Applied Clinical Trials).

The difference is waste at sites that enrol slowly or not at all, and it is also accountability. Every kit shipped has to be received, stored, dispensed, returned or destroyed, and recorded at each step. FDA's BIMO metrics list problems with investigational product accountability among the common inspection observations (FDA BIMO FY2023 Metrics). Fewer kits in the system, tracked automatically, means fewer places for the record to break.

Static versus dynamic supply

1. Ship to demand, not to plan

Enrolment rarely follows the plan evenly across sites. Resupply triggered by actual randomisations and upcoming visits sends drug where patients are, and keeps little stock at sites that are not enrolling.

2. Let the system assign the kit

When RTSM assigns a specific kit at randomisation or dispensing, the right treatment reaches the right participant without unblinding the site, and the assignment is recorded automatically.

3. Catch expiry before it reaches a participant

Expired or soon-to-expire kits should never be assigned. Tracking expiry at kit level, and flagging stock to be replaced, protects participants and avoids a common deviation.

4. Handle temperature excursions with a record

When a shipment or site storage goes out of range, affected kits need to be quarantined until assessed. Recording the excursion and the decision for each kit keeps accountability intact.

5. Reconcile returns and destruction as you go

Sponsors must keep records of investigational product shipped and disposition (21 CFR 312.57), and investigators must keep records of receipt, use and disposition. Reconciling returns during the study, rather than at close-out, keeps the final reconciliation short.

Accountability checklist

• Kit-level tracking from depot to site to participant to return or destruction
• Resupply rules set by site enrolment and visit schedule
• Expiry and temperature excursion handling defined per kit
• Dispensing linked to randomisation and visits
• Returns reconciled at each monitoring visit
• Destruction documented with dates and quantities
• Final reconciliation planned before close-out

What this means by role

• Clinical operations directors and supply managers: dynamic resupply lowers waste and the amount of drug manufactured.
• CRAs: kit-level records make accountability checks at visits faster.
• Site pharmacists and CRCs: the system assigns kits and tracks dispensing, so logs stay current.
• QA and compliance: a complete chain of custody for every kit answers a common inspection question.
• Principal investigators: investigational product records are your responsibility; a system that keeps them current reduces risk.

How Cloudbyz approaches this

Cloudbyz offers Randomization and Trial Supply Management (RTSM) as part of its eClinical platform, built natively on Salesforce alongside Cloudbyz EDC and CTMS. Because randomisation, visits and supply share one platform, dispensing can be linked to the visit and the participant without re-entry. How resupply rules, expiry handling and returns work depends on how RTSM is configured for each study.

See RTSM on one platform

Book a demo or visit cloudbyz.com.