Contract Research Organizations

Global CRO

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.