Nikhil Sambhare
Medical Writer @Reliance Life Sciences Pvt. Ltd
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WORK HISTORY
Medical Writer @Reliance Life Sciences Pvt. Ltd
Navi Mumbai, IN
EDUCATION
Bombay College of Pharmacy (BCP)
M pharmacy, Pharmacology
ABOUT NIKHIL SAMBHARE
As a clinical research professional with an M.Pharm specializing in pharmacology, I excel in conducting extensive literature searches focused on study design, eligibility criteria, and clinical endpoints. My expertise includes preparing and reviewing feasibility assessments for clinical trials (Phase IV, and Real-World Evidence), as well as developing protocols and essential documents such as Informed Consent Forms and Patient Diary Cards.I have a strong background in preparing Clinical Study Reports for Phase trials and managing the 2.4 and 2.5 CTD modules for EMA and Asian submissions. Additionally, I ensure compliance by reviewing Standard Operating Procedures (SOPs) and effectively responding to regulatory queries regarding protocols, CSR submissions, and CTD modules.
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