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Advanced Post Graduate Diploma in Clinical Research, Clinical Data Management and Pharmacovigilance

Advanced Post Graduate Diploma in Clinical Research, Clinical Data Management and Pharmacovigilance

Program Structure

Comprehensive practical knowledge to the clinical research process, drug development process, regulatory affairs, essential documentation, roles and responsibilities, ethics, monitoring, conduct and management of trials, extensive training on clinical research and pharmacovigilance (PV) related issues.

Advantages of the Program

  • Industry Accredited / Certified
  • Application of Clinical Research & Pharmacovigilance in real business-like environment.
  • Completely Job Oriented – Hands-on Training
  • Small Batch – 15 seats
  • Accredited by Accreditation Council for Clinical Research Education, USA (ACCRE) & Certified by Pharmaceutical Society of India.
  • 100% placement – Excellent Placement Record
  • Training by the team of industry experts – both full time and visiting senior faculty.

Back to Courses

Clinical Research

Module 1 Clinical Research Introduction
Module 2 Principles of Pharmacology & Drug Discovery & Development
Module 3 Roles & Responsibilities of Key Stakeholders
Module 4 Preparations & Planning for Clinical Trials
Module 5 Essential Documentation in Clinical Research & Regulatory Submissions
Module 6 Clinical Trials Project Planning & Management
Module 7 Study Start Up Process
Module 8 Clinical Monitoring Essentials
Module 9 Compliance, Auditing & Quality Control in Clinical Research
Module 10 Overview of Clinical Data Management & Biostatistics

Clinical Data Management

  • Introduction to Data Management
  • Study Set Up & Data Management Plan
  • CRF Design & Tracking
  • Edit Check & Edit Check Testing
  • UAT (User Acceptance Testing)
  • Identifying and Managing Discrepancies/Query
  • Management Medical Coding
  • Data Entry/Data Review/Data Validation
  • Database QC and Database Closure
  • Electronic Data Capture
  • Managing Lab Data
  • Collecting Adverse Event Data
  • SOPs
  • CDM Quality Assurance & Audits

Pharmacovigilance

Module 1 Overview of Clinical Research
Module 2 Pharmacology- General Principles
Module 3 Introduction, Definition & Methods in Pharmacovigilance
Module 4 Essentials Documents in Pharmacovigilance
Module 5 Pharmacovigilance Regulations
Module 6 Safety Reporting (including Medical Information) and Processing ICSR
Module 7 Aggregate reports, Signal detection & Risk Management
Module 8 Audits and Inspections
Module 9 Advanced Pharmacovigilance & Analytics
Module 10 Hands on Training on Case Processing and Report generation.

Study Methodology

Hands on training on software, online live classes/classroom

Examination

Online MCQs/Classroom

Certificate

Post Graduate Diploma would be awarded upon successful completion of the program. Program accredited by Accreditation Council for Clinical Research Education, USA.

Faculty

Training would be imparted by the fulltime Think I & Cliniminds faculty and visiting experts from the industry.

Validity

Life Long

Class Mode

Face to Face {3 Months Full time Classroom+ 03 Months Optional Industry Internship, 6 Months Weekend (Saturday/Sunday) no internship for weekend batch}

E learning {6 Months without internship)

Distance Learning {6 months}

Please contact counsellor for upcoming batch details 91 812 910 0876 / 91 484 421 6666 / 1800 1023 566 (Toll Free)

PAY ONLINE

COURSE FEE
Actual Fee 110000+18% GST

*Inclusive of applicable tax

INR 1,29,800 /-

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