New medicine or medical device development process involves exhaustive clinical research and several phases of clinical trials before they are approved. Clinical research guarantees the safety and efficacy of medications, medical devices, treatment plan and diagnostic products for the use on humans. In order to access large pool of practitioners and relevant technologies, clinical researches are mostly conducted at academic medical centres or affiliated research study sites. Clinical research process starts after completion of pre-clinical research which involves researches done in test tubes (in vitro) or on animals (in vivo).
Clinical trials are part of clinical research process. They help in determining safety and effectiveness of treatment or device by performing research studies on humans. Clinical trials are regulated by health authorities and ethics committees and they are conducted in four phases, wherein first two phases tests safety and effectiveness of the drug or medical device, and third phase is conducted to confirm the result of first two phases by thoroughly performing tests on much larger population. Drugs or medical devices are approved for commercial use after clearing third phase and then enter into post-sales studies, which is considered as fourth phase.
To reduce cost, regulatory hassles and patient recruitment burdens, many companies are outsourcing their clinical trial activities to contract research organizations (CRO), which can provide services such as preclinical research, clinical research and clinical trial management. Asia Pacific, especially India, China and Indonesia, are emerging as the major CRO markets because of significantly low cost of developing drugs as compared to developed countries.
Advancement in technology, increase in disease prevalence, and increasing demand for innovative solutions are some of the key drivers for the growth of clinical research and trials market. However, factors such as stringent regulations and higher cost are restraining the growth.
ASDReport.com is the right place for your market research requirements on clinical services, trials & research. Extensive coverage is available on clinical services, therapeutic drug monitoring, preclinical stage partnering, clinical supply chain management, marketed stage deals and much more.