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Valuable Strategies for Successful Globalization of Clinical Trials

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Published - 08.Dec.2015
Valuable Strategies for Successful Globalization of Clinical Trials

We can’t deny the fact that according to modern-day equations and measurements, corporate value is equal to the number of external people (users, investors, sponsors etc.) attracted to the service or products being provided. To present it differently, the more sides are involved, the wider impact the business is said to have. In order businesses to be highly effective and more encompassing, they need to reach as many people and parts of the world as possible. It is called globalization and with the help of digitalization tendencies it gets somehow easier. Just like the automotive, IT and any other industry, the one bound to health care has the goal to achieve the same and aims at stretching itself as further as it can.

When it comes to big companies and corporate giants, globalization is hardly a surprise or something new. However, those that are more rarely choosing to invest or conduct clinical trials in emerging and distant regions are usually considered to be mid-sized or small companies. The reasons behind this can vary. Nevertheless, the most common ones are because smaller organizations lack the resources to direct their focus outside of their local landscapes or they do not implement the right strategies for effective globalization of clinical research. Fortunately, these “habits” adopted by less domineering pharmaceutical associations and communities seem to be falling apart progressively. Over the last decade, more and more drug-developing and trial-conducting organizations arrange their efforts around intensified globalizing practices. Such significantly ramped up interest in globalization is interpreted as a clear comprehension of the need for global clinical studies the benefits of which are many. On the one hand, it will help for widening the scope of clinical trials. Respectively, this will also make it possible for volunteers from all around the world to take part in studies which are essential for

  • finding the cure for plenty of diseases
  • improving health care
  • enhancing the industry

Some Interesting Figures:

According to recent studies, approximately 31% of clinical researches are reportedly performed outside of the USA and 25% of new drug applications (NDAs) comprise of data from international site. What is more, if we are to cite the Biopharma Cold Chain 2012 Sourcebook, up to 65% of the increase in clinical research will derive from researches carried out in emerging market counties in areas like South America, Eastern Europe and Asia Pacific.

Key Strategies for Successful Globalization of Clinical Trials

Performing trials outside of already established regions and locations requires for the incorporation of some very significant strategies. They include:

  • Better Site Management

In some, so to speak, “recently born” or still developing destinations for clinical trials, such activities and projects might not be managed well simply because the field itself is regarded as relatively new. The appointed sites (or staff), then, may not have the necessary experience and all of the required skills. For this reason, the capabilities of people involved should be more carefully and closely managed as well as monitored.

  • Adaptation

It is important for the business, the industry and the purpose of the trial that clinical research associates (CRAs) and clinical monitoring associates (CMAs) not only initiate closer site management but also readjust their approach. This will help them usher better good clinical practices and adapt their methodologies to those of the specific region.

  • Address the provocations and obstacles 

Undoubtedly taking into consideration the diverse challenges and difficulties in clinical trials can manoeuvre the whole process from one direction to another. Therefore, addressing such specifications can play a huge role as to how and where given research is heading for. When planning to initiate a global trial, sites should evaluate a variety of factors – ethical issues, scientific requirements, local conditions and so on. Naturally, there might be challenges in regards to the infrastructure and even the native language so sites should take care of this too even though it might look like a minor thing.

In conclusion, the last decade has witnessed some quite spectacular changes in the field of clinical research. We talk about intensified transparency in clinical trials, increased tech-dependency, digitalization and now follows globalization. More and more companies, from small to big-sized, are trying to expand their views, conquer new worlds and open much more developed horizons for the medical, clinical and pharmaceutical sector. But to do this, however, sites need to reconsider their trend-leading tactics and adapt them to the very nature of each chosen location for their studies.

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