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International Clinical Trials
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As trials become more global in nature, especially as they enter emerging markets, challenges intensify. To respond, pharmaceutical companies need to be thorough in their planning to be compliant and ultimately ensure patient safety. Today, we are seeing new and different regulations proliferating from global regulatory authorities. Long-concerned with GMP, regulators have been turning their attentions towards transportation processes and investigational medicinal products (IMPs) in the context of study conduct. This is a place where numerous GxP principles converge: GMP is a given, but it also includes the rules surrounding clinical excellence (GCP), good distribution (GDP), and storage practices (GSP). Cumulatively, these affect every aspect of the clinical supply chain.
Ultimately, these processes are critical because they ensure a product arrives in a useable condition in order to further the goals of the clinical trial and honour the safety of participants.
Maintaining Integrity in Transit
Many of today’s IMPs require temperature control, especially in the realm of oncology and large molecule research. With clinical trial material, where knowledge of the stability profile is rapidly changing, there are risks involved throughout the transportation chain (usually outsourced and using generic, less well-controlled routes). It is critical to be aware of these risks, and a correctly managed clinical supply chain is paramount.
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About the authors
Vincent Santa Maria has over 30 years of experience primarily in pharmaoperations and services, currently Vice President of Clinical Trial Supplies and Logistics at Parexel International. Prior to joining Parexel, Vincent was the Global President at Bilcare Global Clinical Supplies (now Sharp Clinical Services) and President and Managing Director at Almedica Services Corporation (now Catalent). In his previous experience, Vincent served as Chief Financial Officer at various start-up companies and an Italian pharma company. He is also a certified public accountant in the state of New Jersey, US.
Tony Heeley has over 30 years’ experience working at global pharma companies and CMOs, currently Associate Director of Production Services, supporting label manufacture and production planning and documentation at Parexel International. Prior to joining Parexel, he worked in the clinical supply chain in Shire and Wyeth. Previously, he held positions at Almedica Technology Group, focused on the development of labelling and supply chain systems, identifying client requirements and Almedica Europe, with responsibility for label management, production services, and clinical shipments. He is a registered pharmacist in the UK.
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Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences
Myoderm
Sourcing commercial drugs for clinical trials is a dynamic process. There are many factors to consider: single source or regional sourcing, strategy, price, supply availability, lead times, and documentation are just a few. In the past, there were fewer clinical trials that required commercial drug sourcing, so demand was not as high. Today, the demand for commercial drugs in clinical trials has greatly increased and, as a result, inventory is tighter, orders are monitored more closely by manufacturers, and lead times have increased. This report highlights the key differences in sourcing from the US and EU.
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