How to manage clinical trial supply and site resupply
Too much stock expires, too little stops randomization. Set forecasts, triggers and expiry rules so each site holds what its next patients need.
Interactive tour on demo data. Click through at your own pace, no email asked.
All guides and toursInside the demo
A 30-minute call on your protocol, your sites and the modules you need.
- Forecast demand from recruitment, visit schedule and dose per arm.
- Set a trigger and a resupply level per site, and review them as recruitment moves.
- Keep kit numbers blind: sites see kits, never arms.
- Track expiry and temperature, and dispense against the patient's visit.
Clinical trial supply management gets the investigational product to each site before the patient needs it, without overstocking kits that expire on the shelf. You manage it with a forecast, stock levels per depot and site, automatic resupply triggers and a record of every kit from packaging to the patient.
How to manage supply in 6 steps
- Forecast demand. Combine the recruitment plan, the visit schedule, the dose per arm and the randomization ratio. Add a buffer for screen failures and broken kits.
- Set up the depots. Decide where stock sits by country, and the shipping time from each depot to each site.
- Define site stock levels. For each site, set a trigger level and a resupply quantity. When stock drops below the trigger, a shipment goes out.
- Keep the blind. Label kits with numbers that do not reveal the arm, and let the randomization system pick the kit for each patient.
- Manage expiry and temperature. Block kits close to expiry from dispensing, and quarantine kits after a temperature excursion until the sponsor releases them.
- Dispense and reconcile. Record each dispensed kit against the patient's visit, then reconcile returns and destruction at site close-out.
Mistakes to avoid
- One stock level for every site. A site with ten patients a month and a site with one need different levels.
- Resupply by email. One missed email stops randomization at a site.
- Unblinded kit lists at sites. A kit list with arm codes breaks the blind for everyone who reads it.
Supply in Datacapt
Datacapt Trial Supply Management sits inside the EDC and randomization. You create kit types, map them to treatment arms and periods, and import each site's kit list with batch and expiry date. A site user clicks Allocate in the eCRF and gets the next available kit stored at that site, in the order you imported them. You track each kit through five statuses: In transfer, Received, Available, Allocated and Invalid. When a kit is damaged or has a temperature excursion, the site declares it invalid with a reason. Datacapt records the subject, the user and the time of each allocation. Two permissions protect the blind, Subject ID visibility and Kit Type visibility, and you give them to different roles.
Keep reading
What is the difference between IRT, IWRS and RTSM?
They name the same kind of system: software that randomizes patients and manages trial supply. IWRS is the older web-based term, and RTSM stresses randomization plus supply.
How do you set the trigger level for a site?
Start from the site's expected patients per month, the kits each patient needs between shipments and the shipping time. Review the levels as the site's recruitment changes.
How do you handle a temperature excursion?
Quarantine the affected kits, report the excursion to the sponsor, and dispense them again after the sponsor releases them in writing.