subject: The booming Clinical Research Industry – An overview [print this page] The booming Clinical Research Industry An overview
What is Clinical Research?
Clinical research is the conduct and analysis of human studies in an ethical framework to evaluate the safety and efficacy of a molecule/ medicine before making it available for treating the patients. Clinical research companies or organizations are a great support system to pharmaceutical, biotechnological, stem cells and medical devices companies. They assist these companies to conduct clinical trials in a regulated and credible environment.
With the discovery of new medicines and development of newer treatments, large number of clinical trials is needed to support these medicines and treatments. A clinical research company specializes in distinct services like Pre-Clinical, Bioequivalence (BA-BE studies), Pharmacokinetic studies, End to end Clinical Trials (Phase I-IV) services.
A good CRO demonstrates keen attention to details from the study initiation to site close out visits to database lock to final CSR writing and distribution. The clinical research companies or CRO's work independently or serve as a support system to the industries involved in the new drug or treatment discoveries. Certain companies provide services from method development to Phase IV clinical studies while a few select to have specialized intermediary services. Most of the Clinical Research Companies are known for their commitment, quality service and timely results.
Services offered:Many companies like ClinACE provide full end to end services like Feasibility Studies, Project Management and Planning, Clinical Monitoring, Data Management and Statistics, Medical Writing, Investigator and Patient Recruitment, Site Management, Biostatistics, Quality Assurance, Regulatory Affairs etc while a few choose to provide only specialized services. ClinACE understands that there is a change in trend by companies outsourcing their work to CRO's and a lot of importance is given to local CRO's to conduct studies in particular region as compared to the multinational CRO's. From innovative study design to intensive patient recruitment strategies to ensure delivery of complete and comprehensive clinical study reports, clinical research companies are working hard to ensure innovation in their systems and process which would help them undertake global research projects.
Growing with timeThe clinical trials industry in India was $140 million in 2006 and has been growing at a compounded annual growth rate of 40% for the last 3 years. It is said to rise up to $600 million by 2010. Large and small size Clinical Research Organizations (CROs) are creating facilities, infrastructure and are conscious to ensure having trained and experience resources for maintaining high quality standards in terms of the study conduct and the data credibility as per the 21CFR Part 11.
