BSV Clinical Trials

Clinical Trials

BSV conducts clinical trials at various Hospitals and centres in India and other geographies and countries to evaluate the safety and efficacy of the company’s medicinal products. These clinical trials help in the development of medicines that may benefit people and help find new treatments for different health conditions.

The company prioritizes the rights, safety, and well-being of trial participants who voluntarily consent to participate in BSV sponsored clinical trials. All studies involving human volunteers and patients are carried out in accordance with applicable laws, guidelines, rules, regulations, and policies for the conduct of clinical trials, including Good Clinical Practices (GCP) standards. All clinical trials conducted by BSV are registered prospectively in the Clinical Trial Registry of India (CTRI) and other applicable registries e.g., clinicaltrials.gov etc.

What are Clinical Trials?

Clinical trials are studies conducted on human volunteers who consent to participate in such studies. These clinical trials are to evaluate the safety and effectiveness of medicinal products, medical devices, vaccines, other biologic therapies, and further may also include assessment of new indications for use of already approved medicinal treatments.

Why are Clinical Trials needed?

Clinical trials are required to evaluate potential new treatments in human volunteers and patients to assess whether they should be approved for wider use in the population affected by the specific medical condition(s). A treatment could be a medicinal product, a medical device, a vaccine, or any other biologic therapy.

ICH-GCP E6 (R2) Guidelines (2016), New Drugs & Clinical Trial Rules, INDIA (2019), National Ethical Guidelines for Biomedical and Health Research involving Human Participants, ICMR (2017) are the guidelines and laws that govern e clinical trials in India.

At BSV, we acknowledge the contribution of study participants as well as healthcare professionals (Clinical trial investigators and research staff at Hospital and centres where clinical trials are conducted) who collaborate with us in the company sponsored clinical trials which often address medical needs in important health conditions.

BSV Pharmacovigilance

Pharmacovigilance

Patient safety is our highest priority. At BSV, we put patients first in everything we do. To achieve this goal, BSV monitors the safety and the benefit-risk profile of all BSV products on an ongoing basis through clinical trials, non-interventional observational studies, and spontaneous adverse event reports. BSV has a dedicated Pharmacovigilance team to perform these activities. Our Pharmacovigilance team’s responsibility is to appropriately monitor the safety of the medicinal products and to process incoming safety information and to report this to the Health Authorities, based on applicable regulations in India and other countries where BSV’s products are marketed. In addition, it is the responsibility of all BSV employees, and contractors to BSV, who when they become aware of an adverse event involving a BSV product, to report the potential adverse event as soon as possible to BSV. The staff at BSV undergo regular training on Pharmacovigilance and the procedures related to reporting of a potential adverse event with a BSV medicinal product. The goal is to ensure appropriate and potentially beneficial use of BSV’s medicinal products by patients with different health conditions as per approved indications, while minimizing the impact of medicinal product risks on patients’ health and well-being.