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Clinical Research ::
Key Role:
To design and conduct early stage (Phase-I) and POC (Proof-of-Concept)/Phase-II clinical trials of NCEs.
Key Capabilities:
We have dedicated team with multidisciplinary skills including clinical pharmacologist, clinicians, epidemiologist and pharmacist. The team works with objective to mitigate the unmet medical needs with better and safer innovative drug therapy mainly focusing in area of cardiovascular, metabolic and neurology disorder. Critical activities carried out by the department:
- Preparation of clinical study protocol
- Preparation of Investigator’s Brochure
- CTD (Common Technical Document) preparation
- IND application (Investigational New Drug application)
- Optimization and validation of novel clinical end point assessment methods
- Pharmacovigilance
- Medical monitoring
- Trial management in collaboration with CROs
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