Contract Research Organization for Clinical Research
Clinical Research Organization is the one that perform systematic study to evaluate the efficacy, safety, risks, possible side effects and required dose of a new drug in the treatment, prevention and diagnosis of a disease by enrolling a subset of population (called sample) before being introduced to market for public use. Thus, we can say it is a kind of filter through which those advances in biomedical sciences trickle down, which benefits the public in general.
Previously, this was an ignored field, not considered as an integral part of any pharmaceutical firm. It was not mandatory rather a topic or subject of individual interest. But with time and so many new possible drugs in pipeline, clinical research field expanded extraordinarily and now it covers almost every exciting field of biomedical science, for example, hormones and metabolites, pharmacology (pharmacokinetics, pharmacodynamics, toxicology), cellular and molecular biology, recombinant DNA, formulation of new products and genetic engineering. Industrialization of clinical research made this field a rapidly growing emerging of science and now widely accepted, clearly understood and recognized field where scholars see a lots of possibilities and adventure.
Initially, clinical research organizations did everything including trial design, recruitment of investigators and patients on their own. But gradually with globalization of market and increased consumption of medicines, need of complete clinical trial setup arose, which might have been very costly affair. A complete research setup consists of project management, study and protocol data, expert investigators, clinical data management, statistical analysis, volunteers, clinical monitoring and expert writers. Pharmaceuticals may not have enough internal resources, capital and competent staffs to have such a big setup. Here, outsourcing (to Contract Research Organizations) appeared as an attractive alternative to escape from the limited organizational capacity. Some of the advantages of going with Contract Research Organization include availability of modern technology and expertise accompanied by a greater flexibility. Additionally, two other important factors, which made pharmaceuticals, inclined towards Contract Research are "reduction in time for drug development and cost effectiveness."
TIME: With international market a drug needs to be improved simultaneously by respective national approving authorities at its earliest. So, drug development time must be least. Delay in recruitment of patient and their enrollments in clinical trial is inversely proportional to speed and thus the cost of drug development. Outsourcing solves this problem by enhancing the drug development programmed by recruiting patients quickly. They do a faster study by randomizing patients according to trial protocol delivers a clean and organized data for FDA approval.
COST: Cost of a drug is regulated by certain factors like its original production costs, government policies, and existing competitors in the market and marketing strategy. To reduce the production cost and to stay ahead of the competitors, the companies are bond to come out with more promising new drug and formulations. Contract Research Organizations do the required research work in the most cost effective way on behalf of Clinical Research Organizations.
