Streamlining Clinical Trial Start-Up For Accelerated Drug Development

Altasciences was approached by the sponsor with an urgent need to conduct a Phase 1 multiple ascending dose (MAD) study for regulatory purposes. The sponsor required a shortened start-up time, reducing it from the standard 12 weeks to under four weeks. This involved tasks such as contract execution, regulatory document preparation, IRB approval, procurement of clinical supplies, site initiation, subject recruitment, and database release.

This case study explores the successful implementation of strategies and collaboration in achieving expedited start-up. Emphasizing effective communication, strategic planning, and delegation of responsibilities between the study team and the sponsor, illustrates how these factors accelerated start-up timelines and enhanced the sponsor's drug development program.