Eligibility:

• MBBS, MD,BDS, BHMS, BUMS, BAMS, BPT
• M.Sc. , (Microbiology/ Biochemistry/ Biotechnology/ Bio-informatics/ Chemistry/ Genetics/ Botany/ Zoology/ Life Sciences/ Nursing)
• B.Pharmacy, M.Pharmacy, B.Tech.(Biotechnology)

Clinical Research
A new blockbuster drug takes around $850 million to be developed by an international giant. Nearly 70% of which goes towards clinical trials. In the area of clinical trials, India, with its vast and diverse, disease patient population, is now showing competence at nearly a third for the costs compare to the west.

The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly scientifically controlled settings, and are required for regulatory authority (in the USA, the Food and Drug Administration) approval of new therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. The trial objectives and design are usually documented in a Clinical trial protocol.

Pharmacovigilance

Pharmacovigilance is a discipline which is concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of medicine thereby increasing the safety of drugs in use. It is a study of drug related adverse effect carried out by pharmaceutical industries to suggest warnings and recommendation for product withdrawal.

Pharmacovigilance plays an important role in the use of medicines by providing information about ADRs in the general population. Knowledge of the adverse effects of drugs is important for effective treatment. Communicating the potential harm of drug-use to patients is a matter of high priority and should be carried out by every prescriber. Information collected during the pre-marketing phase of drug development may not detect rare ADRs. The use of a drug during a clinical trial is under controlled conditions. Clinical trials generally enroll a selected, limited number of patients and may not include certain sections of the population. Drug use in special situations or drug interactions may not be studied. Therefore, the post-marketing surveillance of drugs is important. The use of traditional and complementary drugs (e.g. herbal remedies) may also pose specific toxicological problems, when used alone or in combination with other drugs. Therefore, Pharmacovigilance is needed for detecting ADRs and specifically to combat counterfeit and substandard quality products. ADR monitoring ensures that patients obtain safe and efficacious products. Pharmacovigilance plays an important role in ensuring drug safety.

Pharamcovigilance improves patient care and safety in relation to the use of medicines and all medical and paramedical interventions. It also contributes to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging safety and more effective use.

CDM - Clinical Data Management

CDM (Clinical Data Management) is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report forms are stored in CDMS. CDM (Clinical Data Management) comprises of designing and deploying clinical study as well as collecting data and managing data for that clinical study. Electronic Processes are used to plan, collect, access, exchange, manage and archive data for the purpose of reporting the entire clinical study data. Adoption of CDM to drive forward drug research is gaining pace, championed by the pharmaceutical industry, primary health providers, CRO industry & USFDA regulators.