Main set-up services include – study kit design, sourcing and importation.
IMP also supports complementary set-up services per customer’s request:
- Writing of clinical supply chapter for study protocol
- Statistical services and generation of randomization lists
- Purchasing packaging materials according to kit design
- Printed Packaging Materials (PPMs) management - writing, editing, text translation, graphic design and manufacturing of PPMs
- Support in finding global subcontractors as required for the clinical trial supply chain, such as: depots, couriers etc.
- Evaluating and auditing global subcontractors
- Characterizing IVR /IWR systems according to the protocol and Sponsor's request. Finding, evaluating and selecting appropriate vendors and ongoing project management
- Inventory management, planning and forecasting inventory of clinical supply based on parameters such as number of participating subjects and study duration, number of sites and depots
- Professional assistance in writing quality contracts with chosen subcontractors