The T°Safe expert teams evaluates, implements and qualifies new API Supply Chain Routes, IMP distribution and sample retrieval in clinical trials acknowledging that GDP plays a critical role in the transportation of investigational drugs and biological samples.
T°Safe provides the experience necessary for moving API, bulk shipments, and commercial therapeutics on a global scale in addition to products that require strict control of temperature in the development and commercialization life cycle.
T°Safe’s expert team will set up a shipping qualification plan in strict compliance with GDP standards which describes the activities involved with the selection of packaging, logistics, and transportation services needed to maintain product integrity throughout the whole supply chain.
T°Safe’s logistics and biopharmaceutical professionals advise on a stringent chain of custody across country borders in a comprehensive and cost efficient manner.
This includes:
T°Safe assists in designing and optimizing all transportation topics (thermal packaging, data logger, investigator training etc.) within a clinical trial. A service in both directions: IMP from the CTS provider to investigator sites and retrieval of (frozen) blood samples to central labs/speciality labs.
Dedicated project managers as single point of contact are supporting with all issues during the project. The project management of the sponsor (big pharma, biotechs), CTS providers, CROs and central labs are built into the project set up of iDEX. T°Safe’s state-of-the-art login-based transportation management system helps all participants with an intuitive web interface for tracking, booking and monitoring. However, T°Safe is prepared to give a short half hour training during an investigator/study nurse meeting.
T°Safe’s iDEX team establishes the project network via LOGINS and/or individual email reporting to all involved persons (sponsor, CRO, lab, CTS etc.) for a reliable and automatic distribution of all relevant shipping information. All sites, addresses, contacts, type of packaging, datalogging service are implemented upfront in iDEX.
Considerable cost and time savings with iDEX: Full automization of booking can be performed with iDEX interfaces to all leading IVRS systems (or other databases) realised via secured web server technology: allows automatic booking and the exchange of information in both directions.