The common belief that "if a polyherbal product has been prepared as per the traditional system of medicine it is bound to be safe and effective" is not true. If you would like a herbal product to have an edge over the competition then it needs to have a health benefit claim. Well designed Double Blind Randomized Clinical trials can prove such health claims. India has now become the favorite destination to conduct Clinical Research due to modern facilities, high patient population and advanced data management skills.
We at THS have a protocol designed to meet the specific requirements of the clients in the field of clinical registration of new pharmaceutical products from phase I to phase IV, including Bioequivalence, Bioavailability, Pharmacokinetic/Pharmacodynamic studies, Statistical Analysis and Data Management strictly adhering to ICH and GCP guidelines. The company offers competitive and high quality clinical trial services to domestic and international pharmaceutical and Bio-Pharmaceutical companies.
We provide all phases of clinical trials as listed below:
- Phase 1 : The drug is tested on a group of healthy individuals (volunteers), in order to understand the safety, tolerance and the overall effect of the drug on humans. This phase is carried out under careful supervision and 24 hour medical attention is provided to the volunteers for their health and safety.
- Phase 2 : In this stage, the drug is tested on patients, in order to determine whether the drug actually works and treats the patients safely. It also estimates the appropriate dose that needs to be administered, the route of administration for the drug to deliver the desired results and treatment.
- Phase 3 : This stage is carried out on a larger scale and exposes the drug to a variety of subjects at different demographic and socioeconomic levels. It focuses on testing the effectiveness of the drug compared to standard products available in the market and studies its effects on the variants of the disease under consideration. On Completion of the Phase 3, the drug can be introduced in the market on approval by the regulatory agency.
- Phase 4 : The various other effects of the drug are taken into consideration and research is conducted in order to further characterize the safety of the drug. Any side effects or therapeutic indications or any adverse reactions that can occur are studied and evaluated. This phase is also known as pharmaco vigilance or post marketing surveillance. Clinical Research is a continuous process and goes on throughout the lifetime of the drug. One needs to monitor the progress of the drug and check for any sudden issues or problems at regular intervals once the drug is into the market.