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The clinical trial supply space has many examples where current practices following traditional, conservative, historically proven, and perceived “safest” approaches to delivering medication to trial participants are being favored over newer alternatives that have become available. In recent months, regulatory bodies have provided guidance and driven changes that could spur clinical trial supply-chain digitalization and innovation initiatives. This will enable life sciences industry to deliver the greatest benefits to trial participants at the receiving end and help unburden operational teams who support the process throughout. What are the digitalization avenues and how are the regulatory guidelines supporting the process?
About the author
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Dr. Paul Ingram
During Dr. Ingram’s 25-year career, his work has focused on pharmaceutical research and development and medical devices. He has over 15 years of experience in clinical supplies, working in both Phase 1 unit manufacturing suites and trial supplies service companies, including Quintiles (later Aptuit), Fisher Clinical and Catalent.
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