The evolution of healthcare is here. The clinical trial landscape has shed light on operational weaknesses of conventional models and has forced the industry to adapt through agility and innovation. Today, sponsors require flexible solutions for decentralized clinical trials — and that is necessitating new approaches to strategic storage and distribution.
Over the past several decades, the clinical trial industry built up the infrastructure to support site-based studies. Storing supplies in large, centralized Good Manufacturing Practices (GMP) depots has proven effective when sponsors recruit sites across countries to enroll, dose, and monitor participants in large traditional studies. However, the limitations of the model began to emerge as the industry targeted increasingly personalized therapeutic indications, forcing the development of new modalities and decentralized approaches.
The new healthcare landscape requires continuous elasticity. “It’s about keeping flexibility within the setup when creating a protocol and defining the parameters. The aim is to have multiple options. That way, you can leverage a local, regional or centralized depot, but also have the ability to ship Direct-to-Patient (DTP), so you’re prepared if the study needs change from one moment to the next. If a national emergency, natural disaster, geopolitical change or other unforeseen event disrupts the trial, the sponsor can seamlessly pivot to a DTP model without having to file a protocol amendment and wait weeks for regulatory approval,” explains Nina Vas, Vice President, Quality Assurance at Marken.