Description
Preparation of Phase I to Phase III protocol, synopsis, PIS for various therapeutic areas such as respiratory, diabetes mellitus, pain, antimicrobials, cardiovascular and other specialties for India and global submissions.
Writing CSR, IBs, SmPCs, PIs, PILs.
Project assignment and timeline to CRA s Literature search, systematic review of data and its analysis so as to be up to date with latest breakthrough in the therapeutic area.
Working closely with physicians and senior scientists for study designs and protocol development to influence the clinical pharmacology strategy in support of drug development.
Preparing presentations, posters, research articles, abstract manuscripts for publication purpose.