Clinical Research Training Course

Clinical Research Training Course

Clinical research is a division of medical science that investigates the safety and efficacy of medications, devices, diagnostic products, and treatment regimens intended for human consumption

5 in 1 Course

• Training
• Projects
• Exam Assistance
• Certification
• Assignments

Live Projects

Experience hands-on training with industry projects during the Clinical Research Training course.

Takeaways of Your Investment

• 60 hours of intensive training
• Industry-acclaimed Clinical Research Training Course Certification
• Free 1-year subscription to Kodak Consulting & LMS
• Monthly Masterclass & sessions
• The updated industry-oriented study material
• Recorded videos of the sessions
• 100% placement assistance, internship opportunities, and project support exclusively entitled to Medical Professionals
• Add-on supplements provided to effectively deliver projects (Logo Software, E-Books, Question Software, Project Guides/Workbooks, Mobile App, etc.)
• Get the Course Completion Certification for the Clinical Research Training Course

Module 1: Introduction to Clinical Research Industry and Basics of Clinical Trials

• Clinical research
• Types of clinical research
• Clinical trials
• Phases of clinical trials
• Quiz Module 1

Module 2: Pharmacology - Concepts and Application in clinical trials

• Drug nomenclature
• Routes of administration
• Prescriptions
• Pharmacokinetics
• Pharmacodynamics
• Pharmacology glossary used in trials

Module 3: Drug Development Process

• Lifecycle of drug development
• Stages of drug development
• Safety monitoring
• Quiz Module 3

Module 4: Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP)

• Ethics in Clinical Research
• Importance of Ethics in Clinical Research
• ICH-GCP
• GCP Principles
• Quiz Module 4

Module 5: Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies

• History: regulations in clinical research
• FDA Regulations
• Regulatory requirements for conducting Clinical Trials in India
• Other regulatory bodies for clinical trials
• Quiz Module 5

Module 6: Outsourcing Clinical Trials, functioning of Clinical Research Organizations

• Clinical trial outsourcing
• Types of outsourcing
• CROs and their functions
• Quiz Module 6

Module 7: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))

• Role of artificial intelligence in clinical trials
• Application of machine learning methods in clinical trials
• Quiz Module 7

Module 8: Biostatistics- Concepts and Application in Drug Development

• Role of Biostatistics in Clinical Research
• Biostatistician roles
• Tools in biostatistics
• Trends
• Quiz Module 8

Module 9: Clinical Trials- Phases and Trial Designs

• Clinical trial phases
• Trial designs used in clinical trials
• Quiz Module 9

Module 10: Documentation and Data Management in Clinical Trials

• Clinical Trial Data Management
• Responsibilities in Clinical Data Management
• Data Management Workflow
• The stages of CDM
• Clinical data management systems
• Quiz Module 10

Module 11: Safety Reporting Techniques and Pharmacovigilance

• Safety reporting
• Terminologies of safety reporting
• Serious adverse reaction (SUSAR)
• Coding of Adverse Events (MedDRA)
• Pharmacovigilance

Module 12: Quality Control and Clinical Trial Management

• Quality control in clinical trials
• Implementing standard processes/procedures
• Implementing GCP
• Operational QC
• Clinical trial management system
• Clinical trial management system and compliance
• Quiz Module 12

Module 13: Clinical Trials - Medical Devices

• Medical devices
• Guidelines for medical devices
• FDA Regulations
• Approval of medical devices
• Quiz Module 13

Module 14: Protocol Writing and Designing

• Designing a clinical trial
• Clinical Trial Phases & Study Designs
• Clinical Trial Protocol Development
• Quiz Module 14

Module 15: Clinical Trials - Latest Updates : New Drugs and Clinical Trials Rules

• Latest rules in clinical trials
• Accelerated drug trial protocols during COVID
• Quiz Module 15