T°Project: Consulting and Concept

Project Set-up for API, IMP and Samples

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.

  • Logistic route planned to ensure seamless temperature control and optimal transit time
  • Evaluation and supply of all shipping materials and thermal packaging needed
  • Identification and Classification of Export and Import permit/licence and application to 
  • ensure regulatory compliance to involved authorities
  • Project Implementation in T°Safe’s Online Booking System iDEX
  • Test shipments followed by qualification protocols
  • Final design and implementation of customized shipping SOPs

API Supply Chain

Validation/Set-Up for API Supply Chain

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:

  • iDEX support: tracking/booking
  • Cold Supply Chain expertise: Advise on packaging and container setup
  • Specification of best Routes and Timelines
  • Customs clearance, documentation and declarations consulting
  • Regulatory and import/export license support
  • Transportation Risk-Assessment & Management
  • Global Insurance in co-operation with SCHUNCK (leading German insurance)

IMP Distribution

Planning/Set-up of IMP Distribution in Clinical Trials - enhanced by iDEX

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.