The Chemistry, Manufacturing, and Controls Function In the dynamic world of biopharmaceuticals, small and emerging companies play a vital role in driving innovation and advancing groundbreaking therapies. While these companies often possess cutting-edge science and promising drug candidates, they may…
Biopharmaceutical sponsor considerations when selecting a CDMO may include timelines, cost, regulatory requirements, capacity, quality, risks, and previous experience. To help sponsors better understand and prioritize development and manufacturing elements, ISR conducts four annual, manufacturing-specific benchmark studies that ask professionals…
Decentralized clinical trials (DCTs) are studies in which some or all trial-related activities are conducted at a location separate from the investigators’ primary site. DCTs’ numerous benefits include convenience and flexibility for patients, greater opportunities for patient recruitment, increased patient…
