What clinical teams should know about changing trial logistics and how they will affect development
When it comes to clinical supplies, the journey is every bit as important as the destination. And these days, the journey of clinical supplies to investigator sites is becoming costlier and more complex, much like the global trials for which the materials are bound. The price of failure is high. A supply shortfall, or the inability to deliver needed supplies to clinical sites, can delay the start of a trial or cause an ongoing one to grind to a halt. Supply shortages can imperil an entire development program and prevent study patients from receiving the drugs a sponsor has committed to provide.
It’s no wonder that supply chain logistics are estimated to account for as muchas 25% of total annual pharmaceutical R&D costs.1 These cost pressures are projected to grow as a result of an evolution that is altering the clinical trial landscape and generating complex supply chain challenges. Some examples of that evolution in progress include:
- The explosion of cold-chain products in development and move toward shipping even ambient products under temperature controls
- The continuing globalization of trials and impact of supplying trials in remote emerging market locations
- Evolving importation regulations and the potential fallout for imprecise documentation
- The soaring demand for comparator alongside concerns about safeguarding the integrity of the supply chain
- The growing interest in and potential of direct-to-patient studies (DTP)
- Emergence of what one supply chain manager has dubbed an “Amazon-like culture”
- The need for flexibility and contingency planning in a crisis-du-jour world
Much in the way that a GPS constantly adjusts to accommodate shifting traffic patterns and other obstacles, clinical supply chain logistics are adapting to accommodate these developments. In addition to discussing how supply logistics are changing, this paper contains examples of how Thermo Fisher Scientific is incorporating flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.