Changes Affect Clinical Trials

Changes Affect Clinical Trials

Author: Marie Redding, Freelance Writer, Pharmaceutical & Medical Packaging News

Freelance writer Marie Redding quotes Frank Lis, VP/GM Clinical Supply Services, Catalent Pharma Solutions, in her article on clinical trials. Clinical trials are a critical step in the approval process for new drugs. Every detail is preplanned and closely monitored during the trial. Packaging plays an important role and can have an effect on patient compliance as well as the outcome of the trial. FDA’s Center for Drug Evaluation and Research (CDER) continues to look for ways to improve the drug approval process, and recently presented a seminar in which some of the issues surrounding clinical trials were discussed. The need to ensure the quality of trials is one issue addressed by FDA. Another is globalization. As pharmaceutical companies look for solutions to these issues, suppliers are developing ways to offer better solutions for their customers.

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