Clinical Trials Site Management and Business Development

The conduct of clinical trials is one of the most expensive aspects of the development of new medicinal products. It is important, therefore, that the studies should produce high-quality data in the shortest possible time. More companies are trying to use single, larger, complicated trials in an attempt to gain the greatest amount of information about a product and thus reduce the lead time to market. A key element in ensuring this goal is the close cooperation between those responsible for the provision of the clinical trial supplies. The provision of clinical trial supplies is usually organized by a special group, often within the product development department, and it is prudent to discuss a proposed trial with this group at an early stage so that any potential difficulties can be identified and resolved. The major steps in clinical trial supplies are 1)Placing an order for clinical trial supplies, 2) Manufacturing of clinical trial supplies, 3) Blinding of clinical trial supplies, 4) Obtaining comparators, 5) Packaging, 6) Labelling, 7) Documentation, 8) Expiry dating, 9) Dispatch of supplies, 10) Disposal of clinical trial supplies.

The value of some study drugs can reach tens of millions of dollars, making it essential to avoid overproduction, oversupply, and inventory expiration.  With the high costs and strict handling requirements for many biopharmaceutical products entering clinical development, the logistics of clinical trial supplies are more critical than ever.

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