Contract Research Organizations

Contract Research Organizations (CRO) is a service organization that provides support to the pharmaceutical/biotech industry for aiming drug research and development.

Globalization in clinical trial is now become reality. Clinical trial across nations could reduce bottleneck, improve efficiency and saving costs. Data from Tufts Center for Study of Drug Development shows that spending on global clinical trial grew at an annual rate of 10.5 % between 2001 and 2007. In 1997, 95 % of clinical trials were conducted in Europe or the US, by 2007 that figure had dropped to 71 %.

Conducting clinical trial on developing country seems very attractive. Sponsor look beyond traditional border to gain access to appropriate population. Access to patient, geographically diverse ethnic groups, faster recruitment and protocol approval times, less bureaucratic regulatory and treatment naïve population are just some of driving forces. Globalization of clinical trials may also shorten the timeline. In other side, huge population in developing country such as China, India and Indonesia are very promising in marketing of the new drugs in the future. Adoption of the International Conference on Harmonization and Good Clinical Practice (ICH-GCP) and stronger intellectual property protection in developing countries may also have contributed to the globalization of clinical trial.

Expansion into global markets requires a strong working knowledge of countries and their regulation, including approval process for clinical trial materials, local medical standards, coordination of central laboratories, and investigator.

Global financial crisis makes the word seems different as it used to be. Pharmaceutical/biotechnologist companies enter the unprecedented market conditions. It forced them to reinvent themselves in the light of new market conditions. In the most general condition, they have been downsizing, organizing themselves into smaller and more accountable business unit, rationalizing their R & D programs and moving it to outsourced sub contractor. They try to re-focusing and consolidated business on core competencies.

Outsourcing trends become increasingly in global pharmaceutical company market as many values it gained: superior skills/ expertise, cost saving and increase in operational flexibility.

It seems that outsourced to CRO is an answer for pharma/biotech companies to solve the problem in Clinical Trial. Outsourcing brings benefit for both to start up company and big pharma. For a start-up company, which will often not have enough resources for doing project by their self, including data management, biostatistics, and pharmacovigilance, it will be a cost effective solution to completed trial faster so the product can move to the market. For big pharma, it also the right answer since the clinical trial is a secondary business.

The world of pharmaceutical market looks set to undergo a major transformation following the ensuing loss of present blockbuster drugs. The development of new drugs from pre-clinical stage to approval averages about ten years and given enormous development cost.
In recent years, outsourcing has become more strategic in nature as they offer efficient, depth and breadth of capabilities. CRO are capable to completed trial faster and giving more time for marketing time before their patent expires.

Efficient of clinical trial are going to be vital for success of all pharmaceutical companies. In 2000, cost to develop a new drug average US $ 800 millions, with time cost accounting for half of that amount. Accelerate timelines is one of CRO specialty, it could effect in cost reduction significantly.

Indonesia as a large country located in South East Asia with a population of around 237 millions is very attractive and promising for pharmaceutical/biotechnologist companies to conduct clinical trials. Indonesia is the fourth world’s most populous country. Diversity of our ethnic and the abundance of subjects who have never received medication or any previous treatments (naïve patients) are ideal for many of your studies. Beside that, Indonesia has also a high compliance to Good Clinical Practice standard in all clinical trials supportive teams.

The large pool of potential research participants and the lower cost of research provide opportunities to accelerate recruitment and shorten the timelines.

Contract Research Organizations (CRO)