Dr. Mini G.

Years of Experience in Clinical Data Management Training

6

Years of Experience in Clinical Research Training

6

Teaching Experience in detail in Clinical Research Training

• Strong Clinical Experience with deep understanding of the Medical Science, Treatments and its Associated Factors. • Good Basic Knowledge of Clinical trials and phases I, II, III & IV. • Design of the Clinical Protocols and Clinical Trials Summaries. • Understand protocol, development, preparations and planning for Clinical Trials. • Knowledge of Pharmacovigilance, Drug Discovery & Development, Pharmacology. • Knowledge of Narrative writing. • Knowledge of basics of Medical Writing including PSUR Writing. • Sound knowledge of ICH-GCP Guidelines, Schedule Y. • Familiar with principles of 21 CFR-Part 11. • Basic Knowledge of Medical coding. • Knowledge of Adverse Drug Reactions ADRs/ AEs. • Validation of case report form (CRF). • Knowledge of essential documents of clinical research. • Aware of Clinical Research SOPs. • Familiar with Oracle Argus, ArisG database system. • Knowledge of SUSAR, PSUR Concept. • Good Knowledge of Healthcare Providers & Payers. • Understanding of HIPAA, Meaningful Use, HITECH Act, etc. • Knowledge of American Health Care Act, 2017. • Knowledge of Obama-Care Reform / Patient Protection and Affordable Care Act (PPACA). • Good concept of Hospital Workflows. • Understanding of Medicare, Medicaid, MACRA, MIPS, PQRS, CPOE, HL-7, PACS, DICOM, etc. • Knowledge of Medical Coding, ICD-10 & CPT, SNOMED-CT, LOINC Concept. • Understanding and Trying to Learn more on Machine Learning, Artificial Intelligence, RPA, IoT in Healthcare Business, Public Health and Population Health. • Knowledge of Medical Claims, Medical Underwriting concepts. • Understanding and keen interest of Pharma Business and Lifesciences domain.