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Clinical trials are designed to assess the safety and efficacy of treatment in human beings. They usually follow animal toxicology and pharmacology. Clinical investigators screen and recruit patients for predetermined disease characteristics, administer treatment/s, and evaluate and collect data on signs and symptoms under study, for a defined time period. This data is then evaluated statistically to understand the usefulness and side effects of the treatment. Clinical trials are conducted in three phases:

Phase I studies are the initial clinical tests of new treatments. The major purpose of a Phase I study is either to define a safe dose and schedule of a drug/agent or to evaluate the feasibility of combining treatment modalities. Phase I studies are usually done in normal human volunteers, usually between 20-80 in number.

Phase II studies assess the efficacy and toxicity of a new drug/agent, or a new modality of therapy. Using the dosage found to be safe in Phase I studies, the new treatment is given to groups of patients with the actual disease under study. These studies are done in 20-300 patients.

Phase III studies are conducted in 300-3000 patients with the disease condition, usually in multiple treatment centers.

Phase IV studies are post marketing surveillance trials, to assess long term safety issues.

So far, such randomized stringent trials have not been mandated for natural products by any regulatory body in the world. Bioved applies these standards of evaluation to all its products to document safety and efficacy in a consistent manner. Bioved follows ICH (International Conference on Harmonisation) and GCP (Good Clinical Practices) guidelines in all its clinical studies. Bioved also offers such clinical services to its client and partner companies.

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