We are equipped to plan, package, store and distribute clinical trial kits and medications for multi-center national and international clinical trials.
Our clinical trial kits include study specific kit boxes, vial labeling, and box labeling. Our kits are used for drug products, over the counter products, tissue sampling supplies, and devices, and any other product that needs to be tracked within a clinical trial, and may have a lot number or expiration date.
We can accommodate unique configurations (compartments, dose escalation, spare bottles, lid instructions), as required by the study design. Vials may be identified by unique numbers (vial numbers, patient numbers, medication numbers), and can be provided with tear-off labels, to accommodate source documentation documents, and verify dispensing. Kit boxes can also utilize unique numbering schemes (kit numbers, patient numbers, medication numbers), and can be provided with tear-off labeling.
All clinical trial kits are planned out in advance with sponsor input and approval.
Our proprietary database software allows us to manage kit production on a “just in time” basis. Clinical trial kit preparation can follow site enrollment rates, and opening and closing of sites. This conserves precious and expensive investigational drug products, and simplifies tracking of expiration dates and lot numbers.
We can generate randomization codes, or use codes provided by Sponsor statisticians. We can also work directly with clinical trial project management groups and prepare kits “just in time” using centralized randomization and “Kit Request Forms” sent via FAX or email.