Description

Course Description:

The Clinical Research & Trials is designed to provide an in-depth understanding of the principles, processes, and regulations governing clinical research and trials. This program equips participants with the knowledge to design, conduct, and monitor clinical studies while ensuring compliance with ethical standards and regulatory requirements. Learners will gain expertise in clinical trial protocols, patient recruitment, data collection, safety monitoring, and reporting of adverse events. The course combines theoretical insights with practical case studies, preparing professionals for roles in pharmaceutical companies, clinical research organizations (CROs), hospitals, and regulatory bodies.

Key Features of Course Divine:

• Collaboration with E‑Cell IIT Tirupati
• 1:1 Online Mentorship Platform
• Credit-Based Certification
• Live Classes Led by Industry Experts
• Live, Real-World Projects
• 100% Placement Support
• Potential Interview Training
• Resume-Building Activities

 Career Opportunities After Clinical Research & Trials Certification Course:

• Clinical Research Associate
• Clinical Data Manager
• Regulatory Affairs Associate
• Clinical Trial Coordinator
• Medical Writer
• Pharmacovigilance Officer
• Clinical Project Manager

Essential Skills you will Develop Clinical Research & Trials Certification Course:

• Clinical Trial Design
• Protocol Development
• Good Clinical Practice (GCP) Compliance
• Regulatory Knowledge
• Patient Recruitment
• Retention Strategies
• Data Management
• Analysis
• Adverse Event Reporting
• Clinical Monitoring
• Site Management
• Medical
• Scientific Writing
• Risk Assessment
• Problem-Solving
• Communication
• Collaboration

Tools Covered:

• Electronic Data Capture
• Clinical Trial Management
• Statistical & Data Analysis
• Regulatory Submission
• Project Management
• Adverse Event Reporting
• Document Management
• Data Visualization

Syllabus:

Module 1: Introduction to Clinical Research Overview of clinical research and trials History and evolution of clinical studies Key roles and stakeholders in clinical research.

Module 2: Research Ethics & Good Clinical Practice (GCP) Ethical principles in clinical trials Informed consent process International GCP guidelines.

Module 3: Regulatory Framework & Compliance FDA, EMA, and ICH guidelines Regulatory submissions and approvals Clinical trial registration.

Module 4: Clinical Trial Design & Protocol Development Types of clinical trials (Phase I–IV) Designing protocols and study objectives Randomization and blinding techniques.

Module 5: Patient Recruitment & Retention Eligibility criteria and screening Strategies for patient recruitment Retention and follow-up best practices.

Module 6: Data Management & Statistical Analysis Electronic data capture (EDC) systems Data cleaning and validation Introduction to statistical tools (SAS, SPSS, R).

Module 7: Clinical Monitoring & Site Management Monitoring trial sites for compliance Site selection and initiation Quality control and risk management.

Module 8: Safety & Pharmacovigilance Adverse event reporting Safety monitoring and risk assessment Pharmacovigilance regulations and tools.

Module 9: Medical Writing & Documentation Preparing clinical study reports (CSR) Regulatory submission documents Scientific publications and abstracts.

Module 10: Project Management & Industry Applications Managing timelines and resources Clinical trial budgeting and documentation Industry case studies and practical applications.

Industry Projects:

• Designing a Clinical Trial Protocol
• Patient Recruitment
• Data Management
• Adverse Event Reporting Simulation
• Clinical Data Analysis
• Regulatory Submission Preparation
• Clinical Trial Monitoring Exercise
• Medical Writing Assignment

 Who is this program for?

• Medical and Healthcare Professionals
• Life Sciences & Biotechnology Graduates
• Pharmacy Graduates
• Clinical Research Aspirants
• Pharmaceutical Industry Professionals
• Project Managers
• Quality Assurance Professionals

How To Apply:

Mobile: 9100348679

Email: coursedivine@gmail.com