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The role of clinical supply chain management is changing dramatically. Historically a function that is engaged after a study's clinical operations strategy has been established, clinical supply professionals are now playing a more active role in development, study strategy, planning, managing mission critical activities, and in forecasting and mitigating operating risk. To assess this evolving role, the Tufts Center for the Study of Drug Development surveyed 20 senior level executives in large- and mid-sized biopharmaceutical companies. The executives surveyed note that forecasting and risk management has moved to the forefront of their functional responsibilities and as key requirements for study success. Ensuring timely delivery and availability of supplies and investigational drugs for study volunteers has become far more demanding as clinical trials have become globally disbursed and cost pressures have reduced study drug overproduction and clinical supplies inventory.
Despite the importance of accurate supply forecasting and planning, most respondents report using relatively unsophisticated approaches: Excel spreadsheets; in-house forecasting programs; and commercially-available web-based approaches.
The most demanding clinical supply management requirements.
—Tufts Center for the Study of Drug Development, http://csdd.tufts.edu.