Study Synopsis Preparation
Preparation and Compilation of study Protocol Synopsis.
Preparation and review of Clinical Study Protocols as per sponsor and/or applicable regulatory authorities.
Preparation of informed consonant form.

Clinical Protocol Preparation
Preparation of and review of Clinical Study Reports as per sponsor and/or applicable regulatory authorities.
Preparation and review of Clinical study report as per sponsor and/or applicable regulatory authorities.
Preparation and review of Bio Summary Tables/ clinical Summaries/CSBE for different regulatory submissions.
Responsible for designing and reviewing scientific and technical inputs for pharmacokinetic and pharmacodynamics studies.
Responsible for reviewing regulatory guidelines with the current requirements for CRS related activities.

Pharmacy Activities
Responsible for dispensing the investigational drug products as per the randomization schedule Bioavailability / Bioequivalence Studies.
Issuing IPs to Clinical Unit before dosing and collecting unused IPs and stored in pharmacy.
Review procedures for pharmacy operations.

📌 Research Analyst Hyderabad
🏢 QPS Bioserve India
📍 Hyderabad