CLINICAL SUPPLY MANAGEMENT ARTICLES
Can Your Operating Model Grow? Preparing Clinical Supply For What Comes Next
Having previously explained why early-stage biotechs should avoid overbuilding, Alicia Collins, of Tune Therapeutics, continues the discussion here in part 2, with thoughts on scaling clinical supply, selecting partners, and preparing for future constraints.
CLINICAL SUPPLY MANAGEMENT RESOURCES
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Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.
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Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.
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Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
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Rachel Curran, Head of Sourcing Services and Special Accounts, discusses the requirements, challenges, and solutions to comparator and co-therapy drug sourcing for clinical trials.
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To better understand sponsors’ perspectives on DTP distribution of clinical supplies, 234 individuals involved in clinical supply and operations were recently surveyed. Click to get the results!
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DtP trials are a win-win for patients and sponsors. The purpose of this white paper is to provide in-depth information on the various DtP approaches while offering insight into best practices when incorporating DtP into the protocol.
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By offering guidance on optimizing ROI from extensive data collections and various endpoints in clinical studies, learn how IRT technology can enhance the data-driven approach for sponsors.