Challenges Facing Rare Disease Clinical Trials

By Clinical Trial Management, Cold Chain, Outsourcing, Packaging and Distribution, Supply Chain No Comments

The USA Orphan Drug Act of 1983 created incentives for pharmaceutical companies to research and create new drug therapies for rare diseases. These incentives include tax breaks, exclusive marketing rights, unique research grants and fast-tracked FDA review processes. As a result, the clinical costs associated with the development of an orphan drug are less than those associated with non-orphan drugs1….

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3 Packaging Decisions You Can Make to Improve Clinical Trial Compliance

By Clinical Trial Management, Outsourcing, Packaging and Distribution No Comments

Study non-adherence is an ongoing problem surrounding clinical trials. Noncompliance drives up research costs and increases the time it takes new medicines to make it to the market. One study suggests that costs associated with noncompliance are as high as $1.5 billion by the time the investigational product (IP) is fully developed 1. Considerate IP packaging is one way researchers…

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