Advanced Clinical Research Course

Your First Step in the Clinical Research Profession

One of the global sectors with the quickest rate of growth is clinical research. Medical research is carried out, funded, and distributed via this international market. It functions at the nexus of business and healthcare. Within the field of healthcare science, clinical research examines the efficacy and safety of novel drugs, technologies, diagnostic tools, and treatment plans meant for human consumption.

The best clinical research training organization in Pune, with a 100% placement assistant

Top Certified Programme

Clinical Trail and Clinical Research (BA/BE)

Module 01: Introduction Module 02: Monitoring of Trials Module 03: Drug Development Process Module 04: Regulatory Affairs Model 05: Medical Writing: Protocol, ICF and Study Report Preparation

Good Clinical Practices (GCP)

Module 1: Introduction to Clinical Trials Module 2: Overview of ICH- GCP Guidelines and its new revision Module 3: Principles of ICH GCP- Responsibilities, Sponsor, Investigator and Ethics Committee Module 4: Essential Documents- Informed Consent, Protocol and Investigator’s Brochure Module 5: SAE Reporting, Audit & Inspection Module 6: Consequences of GCP non-compliance Module 7: GCP Guidelines for Medical Devices Module 8: Industry specific case studies

Pharmacovigilance (PV)

Module 1: Introduction to Pharmacology, Clinical Trials and Pharmacovigilance Module 2: Adverse Drug Reactions and Safety Reports Module 3: Methodologies in Pharmacovigilance Module 4: Management Systems and Drug Dictionaries in Pharmacovigilance (Argus, ArisG, MedWatch, MedRA, WHODD etc.) Module 5: Seriousness & Expectedness & Causality Assessment CriteriaModule 6: Aggregate Safety Reports Module 7: Pharmacovigilance Regulations in Various Countries Module 8: Pharmacovigilance Programme in India (PVPI) Module 9: Signal Detection and Data Mining Module 10: Pharmacovigilance of Herbal Drugs & Medical Devices Module 11: Pharmacovigilance Compliance and Inspections Module 12: Hands-on training on Argus, ArisGlobal, ABcube etc software platforms. Module 13: Case Study

Clinical Data Management (CDM)

Module 1: Introduction to Clinical Research, Roles & Responsibilities of Key Stakeholders Module 2: Preparations, Planning for Clinical Trials and Essential Documentation in Clinical Research & Regulatory Submissions Module 3: Introduction to Data Management Module 4: CRF Design Considerations Module 5: Data Entry, Remote Data Entry Module 6: Identifying and Managing Discrepancies Module 7: Data Management Plan Module 8: Electronic Data Capture Module 9: Tracking CRF Data Module 10: Managing Lab Data Module 11: Collecting Adverse Event Data Module 12: Creating Reports and Transferring Data Module 13: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML)) Module 14: Case Studies

Medical Coadding

Module 1: Introduction to Clinical Research, Roles & Responsibilities of Key Stakeholders Module 2: Preparations, Planning for Clinical Trials and Essential Documentation in Clinical Research & Regulatory Submissions Module 3: IntrodModule 01: Introduction to Medical Terminology. Module 02: Anatomy Structure. Module 03: Medical Terminology. Module 04: Medical Ethics. Module 05: ICD-9-CM Coding Manual. Module 06: Infections using ICD-9-CM. Module 07: Digestive System using ICD-9-CM. Module 08: Coding for Pregnancy using ICD-9-CM

Good Documentation Practices (GDP)

Module 01: Introduction Module 02: Document Required Module 03: Record to be Maintained Module 04: ALCOA+

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