International vs Local Clinical Trials
There are many considerations to be made when choosing between international clinical trials and local clinical trials. This includes political changes, the relationship between organizations and many more. Pharmaceutical companies face these issues daily, and with clinical trials usually taking between 10-12 years to complete it means that these firms need to decide well in advance what they want to do. This article will highlight the comparisons between international and local clinical trials.
Contract Research Organisations:
To get a better understanding of your choice, it’s best to look into the specific contract research organisations (CROs) on offer. For the past 20 years, many CROs have been established around the world for their clinical outsourcing activities, both locally and internationally. There are a number of international CROs with the knowledge and experience in many geographic locations, which helps the approval take place in a number of countries. What also needs to be taken into account is the various aspects of those clinical trial services, such as the number of phases they do and their methods.
The biggest concern for clinical outsourcing are the lack of knowledge on local regulations and constant requirement changes. This situation exists in East Asia, India, parts of South America and Russia according to the Medical Research Network. In the US, the main regulatory body is the Food and Drug Administration (FDA), whilst the European Medicines Agency (EMA) is its European counterpart. For international clinical trials, vendors need to be mindful of other countries’ legislations they are supplying drugs to, to ensure experiments are carried out successfully and legally.
In order to be approved commercially and ensure clinical trials acquire more data, they need to meet the conditions of Conformite Europeenne (CE). This is the medical device manufacturer’s claim that a product needs to meet the essential requirements of for all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). The CE mark is a legal requirement to place a device on the market in the EU. It is in that sense similar to the Medical Device 510(k) of FDA in the US.
Logistics and Shipping:
What also needs to be planned well-ahead are the logistic methods of the vendors. It is perfectly possible for international clinical trials to be tracked as many CROs use track-and-trace systems, such as an interactive response technology (IRT) system which monitors the supply, the site and location of the drug.
On the other hand, the shipping method differs for international and local clinical trials as there are many considerations to be made, including expenses and time consumption. The best method for international clinical trials are airplanes as it is quicker, but compared to other transportation methods they are more expensive. For local trials, trucks are the most useful tool but can be delayed depending on the situation. For both international and local clinical trials, ships are cheaper but considerably slower.
Would you like to find out more about the challenges of international and local clinical trials? Our first session will be a panel discussion organized by clinical professionals from Impel NeuroPharma, Qu Biologics and Aquinox Pharmaceuticals, on comparing international with local trials to assess optimum studies. This October, the Outsourcing in Clinical Trial Pacific Northwest 2018 conference will also address the solutions to maintaining a profitable pharmaceutical company. For more information, please visit http://www.arena-international.com/octpnw or alternatively email us at: firstname.lastname@example.org
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