Dr. sravya koyyala

 Medi data Rave.  Query management, Listings review, Vendor and SAE reconciliation, Data dump review, 3rd party vendor reconciliations, Missing pages review, Data base locking, freezing and inactivation activity, Agent specific review, Subject status report, BIOS data review, Metrics preparation.  Knowledge on Informed consent Process, UAT, Data validation manual, 21CRF part 11, eCRF, eCCG guidelines, Standard operating procedure (SOP), Good clinical practice (GCP), Clinical trials, drug development.

 Performed data extraction/analysis of clinical trial related data from publications, standardization of curated data as per the requirements.  Literature screening in PubMed, Embase, Cochrane, Medline. Building source databases, Objective data bases based on inclusion criteria for every indication.

 Performed GLP studies (MTD, dose range finding studies, PK, Vaccine efficacy, Acute, sub-acute, chronic, sub-chronic, chronic toxicity studies in large animals (Beagle dogs, Swine).  Prepared Protocol, amendments, reports, handled raw data, test item, formulation preparation (oral, intravenous, capsule), dosing (Oral gavage, IV), serios adverse event monitoring, site monitoring, statistical analysis, sponsor communication, audits.