Overcoming the Challenges of International Clinical Trials
International clinical trials are always at risk of being disrupted by a number of factors. This ranges from changing political landscapes, the relationship between organizations and many more. Pharmaceutical companies face these problems everyday. Knowing that clinical trials usually take 10-12 years to complete means that these corporations need to plan well-ahead to avoid any interference. Here’s an insight into the challenges of international clinical trials and how to overcome them.
Logistics and Shipping
Choosing the right couriers is essential. Logistics compliance teams from couriers like Cryopdp and PAREXEL, work with various government agencies to adequately classify goods. This includes addressing questions on the intended use of the clinical supplies, or advising the teams to make intelligent decisions in regards to the selection of sites and countries upfront in the clinical trial process. It’s useful to have an interactive response technology (IRT) system that manages the supply, knows the site and location of the drug, and can also predict what patients will need.
There are many considerations to be made when choosing the mode of transport, including expenses, time consumption and temperature. Airplanes are the best for international clinical trials as the transit time is quicker than others, but expensive. Ships are considerably cheaper and good for more local trips, but they’re also time consuming for long haul journeys. Similarly, trucks are useful locally and saves money, but are largely unsuitable for the demands of international clinical trials.
No matter what travel method is used, the temperature of the batch is at most risk of being effected. This can be monitored by a tattle-tail indicating device, device tool designed to visually identify if a product’s temperature limit was exceeded. They are cheaper, more efficient, and provide evidence that the temperature limit has been crossed and the product is no longer useable.
Due to a lack of knowledge about the local regulations as well as constant changes to those requirements, clinical trials have been seriously affected in countries like Brazil, Russia, India, China and Japan according to the Medical Research Network. Whereas throughout Europe and the US, the regulations are stable thanks to the Food and Drug Administration (FDA) and the Medical Device Regulation (MDR). It is vital companies are aware of the regulations taking places in the countries they are supplying to. The FDA is responsible for ensuring the safety of human and veterinary drugs in the US, as well as biological products, and medical devices. If a packaging and labelling vendor is in the US but the manufacturer is in Europe, the requirements and relevant FDA documents have to be submitted in order to be approved. The same agreement applies to clinical trial medicines entering Europe, as the MDR is responsible for what is being produced in or supplied throughout the EU.
Would you like to find out more tips on international clinical trials? Hear from NantCell VP of Operations Jelena Berglund, as she explains the on-going challenge of importing and exporting clinical materials in different countries. This October, the Clinical Trial Supply Southeast 2018 conference will also address ways to handling a growingly complex supply chain. For more information, please visit http://www.arena-international.com/ctssoutheast/ or alternatively email us at: firstname.lastname@example.org
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