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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What Does a Successful Cold Chain Look Like?

By Clinical Trial Management, Cold Chain, Health Care Research, Packaging & Distribution, Supply Chain No Comments

Clinical supply chain logistics are constantly changing as new technologies and developments are adapted. While multiple factors are responsible for reshaping the clinical trials logistics landscape, the explosive evolution of biologics is the key driver. In order to preserve the integrity of biologics and other highly sensitive medicinal products, as well as maintain the validity of trial results, cold chain…

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3 Steps for a More Sustainable Clinical Supply Chain

By Clinical Trial Management, Packaging & Distribution, Supply Chain, Sustainability No Comments

Over recent decades, the heightened awareness of sustainability issues among consumers, combined with the prevalence of corporate social responsibility and an increase in regulatory standards, has put pressure on the clinical trial and pharmaceutical industry to reduce the environmental impact of its activities. The potential benefits from creating a greener clinical supply chain includes an enhanced brand reputation and operational…

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5 Risks Most Clinical Supply Professionals Overlook

By Clinical Trial Management, Supply Chain No Comments

Risk-awareness is a critical component of successful clinical supply management; you cannot fix the problems you don’t know about. We see clinical supply professionals overlooking the same key risks time and again. Let’s address them now. Expiry dating One of the biggest impacts to the success of clinical supply management is expiry dating, particularly of the product itself. As formulation…

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