Before any drug or formulation makes it to the chemist shelf, it must pass a lengthy approval process involving clinical research professionals.

Clinical trials allow medical profession and patients to gain information about the benefits, side effects and possible uses of new drugs as well as new ways to use existing medicines. It augments the process to translate results of basic scientific research into better ways to prevent, diagnose and treat various diseases.

Advances in drug development and biotechnology offer enormous opportunities to conduct clinical trials. This requires a coordinated approach to enhance interdisciplinary, scientifically driven clinical trials. Panacea Biotec is playing a significant role in facilitating international clinical trials and exploring new opportunities to speed discovery, development and delivery of products to improve the lives of people.

Panacea Biotec is igniting its potential towards quality clinical research. In fact, strengthening clinical research will be a driver for introducing novel healthcare products for patients with unmet medical needs.

Panacea Biotec carefully designs research study projects to investigate medical treatment in people, under the supervision of highly qualified professional investigators.

The organization has been involved in the clinical trials of Vaccines and other drugs in the management of Pain, Diabetes, Hyperlipidemia, Osteoporosis, Renal Disease, Fever, Inflammation and Allergy, Tuberculosis and Gastrointestinal diseases.

Panacea Biotec undertakes monitoring and evaluation throughout the whole life cycle of its products. Panacea Biotec with a holistic approach generates data on non clinical (pre-clinical), clinical (Phase I, II, III, IV) and post marketing, besides several BA/BE studies. Global expansion strategy is being carved out to conduct highly specialised clinical studies across geographical locations.
Clinical trials are categorized into four phases. Phase I trials (Human pharmacology) are directed towards estimation of safety and tolerability with the initial administration into humans. Phase II trials (Therapeutic Exploratory Trials) evaluate effectiveness for particular indication in 100-300 patients and determine common side effects. Phase III trials (Therapeutic confirmatory trials) confirm the therapeutic benefit in 1000-3000 patients. Phase IV trials are studies (other than routine surveillance) performed after drug approval and related to the approved indication(s). They include additional drug-drug interaction(s), dose-response or safety studies and trials designed to support use under the approved indication(s), e.g. mortality/morbidity studies, epidemiological studies etc.

For all clinical trials there is prior need for permission granted by the Licensing Authority, and the approval obtained from the respective ethics committee(s). All trials Investigator(s) should possess appropriate qualifications, training and experience and should have access to such investigational and treatment facilities as are relevant to the proposed trial protocol.

It is the responsibility of the sponsor of the clinical trial for implementing and maintaining QA systems to ensure that the trial is conducted and data generated, documented and reported in compliance with the protocol and GCP Guidelines. Apart from the sponsor there are certain responsibilities that lie with Investigator(s) and Ethics Committee. The investigator is responsible for trial conduct according to protocol and the GCP Guidelines and documentation for the tasks performed by them while the Ethics Committee is responsible to safeguard the rights, safety and well being of all trial subjects.

Panacea Biotec has efficient infrastructure to timely initiate all stages of clinical trials, generate and communicate data in the community and provide information to clinicians, patients and advisory groups. Its clinical research function is re-engineering to incorporate multidisciplinary research, translational research, integrated clinical research network and clinical research informatics.

Panacea Biotec has a highly energetic and resourceful team of clinical researchers engaged to execute well designed clinical studies strictly compliant to GCP in India and across the world.