bharat S.

My professional Summary


---> Monitoring of Clinical Studies Phase II & III
Sound knowledge of;
--ICH-GCP
-- Indian GCP
--Schedule Y
--ICMR guidelines
-- 21 CFR part 11, 50, 54, 56, 312 and 314
-- 45 CFR part 46,160 and 164

--->BA/BE studies (Phase I)
-- SOP Preparation and Review.
-- Maintained and recruited more than 750+ healthy male volunteers for clinical studies
-- working knowledge of Biometric system.
-- Designing of paper Case Report Form, Informed Consent
-- Communication with IEC, Sponsor and third party vendors
-- Assisting Principal investigator in Final report making.

Therapeutic area:
-- Endocrinology
-- Urology
-- Hematology
-- Hypertension
-- Obesity
-- Infectious Disease
Specialties

Monitoring
-- 27 FV
-- 15 SIV
-- 05 IMV/ month
-- 02 SCV

Clinical Trial
• Review of Investigative site
• Coordinating for Investigator meeting.
• Project Start up
• Pre-study site visit
• Site initiation visit
• Interim monitoring visit
• Site close out

--Translation of ICF/PIS in regional languages Hindi and Marathi
--Managed more then 23 Bio equivalence studies for both national and international clients