Clinical research is extremely valuable and an essential part of investigating new treatments and bringing them to the market. However, to do this effectively it is important to have the right professionals on board to run these trials around the world.
This is because not only is the relationship the pharmaceutical company has with the Contract Research Organization important, but also the ability, management skills, timing and budgeting of this organisation are critical too.
Although some pharmaceutical companies can afford to only outsource some of the necessary processes of a trial, others will entirely outsource to a Contract Research Organization (Contract Research Organization) for their clinical research. In either case, here are some of the most important aspects of doing this.
Firstly, the geographical reach of the Contract Research Organization is very important, as this determines the selection of participants available to take part in the research and also the disease profiles able to be studied. Many developing countries in the world offer ideal patient profiles, as there can be a mix of different diseases, from infectious diseases to ‘modern day’ diseases such as heart disease and cancer.
Therefore, finding a Contract Research Organization that has an appropriate reach in a particular region of the world is important. This matters not only for certain disease profiles, but also for patient enrolment and retention. In many cases it can be very difficult to enrol and keep patients, but a Contract Research Organization with a strong influence in a geographical location can make a huge difference.
An example of this would in Latin America, where clinical trials and research are only just starting to develop in a significant way. With the right understanding and contacts within countries in this region of the world, the right Contract Research Organization can boost participation and retention in clinical research trials for the pharmaceutical company that it represents.
Quality is another very important aspect of clinical research in ensuring that all trials are carried out in accordance and adherence to relevant legislation and regulation. This can seriously affect the validity of any results obtained, yet not all research in different regions the world may be up to scratch.
Furthermore, the pharmaceutical company that is looking to carry out the research will be based in a country where specific standards are required. From North America and Europe right through to Far East Asia, there are different criteria and standards to meet, and specific regulation to follow.
The right Contract Research Organization in clinical research will need to make sure that it has knowledge of all the relevant protocol and regulation to abide by when carrying out trials for a pharmaceutical company. If not, this could lead to invalid and low quality results and therefore an immense waste of investment.
Looking at the experience of a particular Contract Research Organization in carrying out successful research in their region of the world will be an indicator of whether regulation and protocol can be abided by, and will also be an indicator of successful patient recruitment and retention rates. This information can therefore be very valuable to pharmaceutical companies when making their choice.
In addition to this, a strong indicator of future success is the Contract Research Organization’s ability to communicate clearly and effectively every step along the way with the pharmaceutical company that is looking for the research to be carried out on their behalf. Therefore, any contracted should make sure that excellent and efficient communication is present from the beginning for best results.