In the Drug Development process clinical research plays a key role because the approval from the FDA requires clinical trials to signify the safety and efficacy of pharmaceutical products. Clinical research helps in grasping and applying knowledge for products or process in prediction, prevention, diagnosis, treatment and cure of disease in humans. Clinical research includes research on humans, epidemiological, behavioral, and health services research. Patient oriented research explores the process of human diseases, effects of drug therapies etc. Epidemiological and behavioral research assesses the division of and factors associated with disease, behavior and health in general. Research related to health services analyzes the effectiveness and efficacy of the treatment in real world. Clinical trial industry is a booming industry and perpetually evolving and advanced clinical studies are being established at an ever growing pace. Clinical trials are the main part of the clinical research and are organized in four phases which have the different cause and helps scientists to find the answers of different questions.
Pharmaceutical and Biotechnology companies have been experienced the crucial task of minimizing their drug costs which had forced to most of the companies to analyze cost saving options such as outsourcing. Most of the companies in this area have already acquired the strategy to outsource their processes to specialist service providers such as CRO. This approach helps to bring improved efficacy in terms of timelines, regulatory norms and costs. In India Contract research organization is one of the growing markets. The market is majorly bifurcate into Drug Development/ clinical trials, Drug Discovery and Post marketing services. Additionally on the basis of drug discovery services type the market is segmented into clinical services, biology services, chemistry services. India Contract Research Organization Market is projected to grow at a CAGR of 20.4% and is expected to reach US$ 6,310.5 million by 2022. In India contract research organization market, drug development/clinical trials accounted for the largest market share in 2016.
India became fully adaptable to TRIPS in 2005. In order to promote clinical trials in INDIA policymakers have been trying to make some changes in the policy framework and regulatory environment. These changes have stimulated the International Clinical Research Organizations (CROs) to broaden their clinical research in India. Nearly fifth of all trials globally are hosted by India which are having huge potential for financial and scientific gains. CROs are taking an edge of gaining large patient pool, qualified medical investigators, lower drug development costs and winding up the clinical trials in India on time.
There are multiple reasons global pharmaceutical companies are outsourcing their projects in India for enhancing the profit, cutting the cost of drug development and shoot the regulatory approval. In India clinical trials are 50%cheaper as compared to developed countries.
Cheap human resources are the main reason for the low cost of drug development, low recruitment cost and the lesser rate of compensation for injury sustained or death during the process of clinical research. The Government of India summons the multinational companies for the clinical trials to be conducting in India in order to allure foreign investments for financial and technological gains in this area. The dogma of clinical research is that it should be of broader welfare to the society. Societies cannot be of two different types- one that takes risk whereas the other harvests the benefits. Clinical trials.gov is a registry and result database of public and the clinical trials which are privately supported on human participants conducted globally. On the other hand, CTRI dataset, is conventionally published by the Indian Council of Medical Research (ICMR) and it has been made mandatory by the Drug Controller General of India (DCGI) to register the trials on CTRI before enrolment of first participant of any category of intervention including drugs, surgical procedures, preventive measures, lifestyle modification, devices, educational and behavioral treatment, rehabilitation strategies and trials are conducted in the Department of AYUSH.
A Clinical Research Organization/ Contact Research Organization (CRO) is an organization that offers services in pharmaceutical, Biotechnology and medical devices industries in a form of research services outsourced on a contract basis. Services include but are not limited to: Product development, formulation activities, Phase 1 to 4 activities, data entry and clinical data management, Project management, IRB approval, statistical analysis, and other necessary activities to apply for a New Drug Application (NDA). India has been a hub of organizing and regulating clinical trials. The CDSCO headed by DCGI has set forth some rules and regulations for the clinical trials to be done in India. The drug approval process in India has faced challenges in recent years some around mandatory licensing of patents, Government price control and narrow standards of patentability. It is compulsory that clinical trials in India should be as per ICH-GCP guidelines followed by amended Schedule Y of the Drugs and Cosmetics Act. The CDSCO handles the approval process and apart from CDSCO approval, DCGI has given authorization to each state’s drug control authority to regulate the manufacture, sale and distribution of drugs. The objective of Drugs and Cosmetics rule was to upgrade patient’s safety, reporting patient’s timeliness of serious adverse events including deaths.
ProRelix Research is a leading global award winning clinical research organization (CRO). Apart from India, ProRelix Research also functions as the best Clinical research organization (CRO) in US where it provides services like clinical data management (CDM). Since 2011 we are specialized in providing pharma/Biotech with clinical project management, feasibility and site selection to meet the timely enrollment goals and site management. We provide full range of clinical trials implementation in United States also. Our innovative approach support biopharmaceutical clients who perform complex clinical trials. Our core services which provide expertise in various therapeutic areas such as oncology, CNS-Including Pain and Psychiatry, Autoimmune Inflammation, cardiovascular, Ophthalmology, Endocrine/Diabetology. As a company that assists in complex clinical trials, we know how to support the demands and needs of the customers with flexibility and clarity through the study, by providing high quality services to meet current and future needs. As a skilful Clinical research organization we assist our clients with clinical Data management and regulatory expertise. ProRelix research has become the excellent supplier of choice for many top pharmaceutical companies.