Advanced Diploma in Clinical Research, Pharmacovigilance & Clinical Data Management
With Regulatory Affairs/Medical Writing
Your Path to Success is Guaranteed
Programme Fees
₹79,000/-(Pay After Placement)
(Pay Registration fee Only)
GST will be charged at checkout View the payment plan
Duration
6 Months
(500 + Hours)
(Course includes theoratical, Practicle, Assignments and Projects)
Giving students the ability to pursue their dreams
Genie Learning enables students to achieve their aspirations by offering Pay After Placement, allowing them to focus on their education without financial stress. Our Global Curriculum equips students with internationally recognized skills, while Senior Industry Trainers provide expert guidance and real-world insights. Through specialized Software Training and hands-on Industry Internships, students gain practical experience, bridging the gap between academic learning and professional application. Together, these elements create a comprehensive learning environment that fully prepares students for successful and fulfilling careers in clinical trial industry.
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Program Advantage
Our comprehensive program in Clinical Research, Pharmacovigilance, and Clinical Data Management offers an immersive learning experience tailored for your success in the clinical research industry. Through flexible online learning, you’ll delve into essential topics such as study design, data management, regulatory compliance, adverse event monitoring, and safety reporting. The curriculum integrates advanced Artificial Intelligence and software training, keeping you at the forefront of technological advancements in healthcare. Learn from senior industry trainers and gain invaluable hands-on experience through structured industry internships. With our robust Guaranteed Placement support, and Pay After Placement options, we ensure you are fully prepared and connected to secure a rewarding career in healthcare and pharmaceuticals.
Global Curriculum
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E-Learning
Artificial Intelligence
Industry Internship
Senior Industry Trainers
Guaranteed Placement Support
Course Module
Clinical Research
- Drug Discovery & Development
- Overview of Clinical Research
- Regulations & Guidelines in Clinical Research
- Roles & Responsibilities of Key Stakeholders
- Preparation & Planning of Clinical Trials
- Essential Documentation in Clinical Research & Regulatory Submission
- Study Start-Up Process
- Clinical Monitoring Essentials
- Compliance, Auditing & Quality Control in Clinical Research
- Hands-On Software Training
Pharmacovigilance
- Overview of Clinical Research
- Pharmacology – General Principles
- Introduction to Pharmacovigilance
- Pharmacovigilance Regulations
- Hands-on Training in Case Processing and Report Generation
- Safety Reporting and Processing ICSR
- Aggregate Reports, Signal Detection & Risk Management
- Documents in Pharmacovigilance
- Audits & Inspections
- Advanced Pharmacovigilance & Analytics
- Hands-On Software Training
Clinical Data Management
- Overview of Clinical Data Management
- Clinical Data Integrity
- Data Management Plan
- Design of Case Report Form
- CRF Tracking
- Electronic Data Capture
- Data Entry Guidelines
- Edit Check Creation, Validation, Programming
- Discrepancy Management
- Data Transfer in Clinical Data Management
- Medical Coding Dictionaries
- Laboratory Test in Clinical Trials
- Creating Reports
- Adverse Event Reporting & Reconciliation
- Audit Trail
- Database Lock
- Quality Assurance in Clinical Data Management
- QMS, Audit & Inspection, SOP Compliance
- Hands-on Software Training
Regulatory Affairs
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Introduction to Regulatory Affairs
-
Drug Development Process
-
Regulatory Submissions
-
Good Clinical Practice (GCP) and Ethics
-
Regulatory Strategy and Intelligence
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Quality Assurance & Compliance
-
Risk Management in Clinical Trials
-
Post-Marketing Regulatory Requirements
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Communication & Collaboration
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Current Trends and Future in Regulatory Affairs
-
Career Development in Regulatory Affairs
Medical Writing
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Introduction to Medical Writing
-
Basics of Clinical Trials
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Data Collection & Management
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Regulatory Writing
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Scientific Writing
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Data Presentation and Interpretation
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Writing for Different Audiences
-
Ethics and Compliance in Medical Writing
Artificial Intelligence for Clinical Trial
- Consideration Introduction to AI in Clinical Trials
- AI Technologies and Tools
- AI in Clinical Trial Design
- AI in Clinical Data Management
- AI in Safety and Pharmacovigilance
- Machine Learning Basic
- Machine Learning Algorithms
- Natural Language Processing
- Ethical & Regulatory Consideration
- Future Trends and Innovations
- Hands-on Projects
Pre-Placement Training
- Resume and CV Building
- Cover Letter Writing
- LinkedIn and Professional Networking
- Interview Preparation
- Communication Skills
- Soft Skills and Professional Etiquette
- Industry Insights and Networking
- Final Assessment and Feedback
- Industry-Specific Case Studies
Our mission is to provide more accessible & Quality education
At Genie Learning, we believe in putting your success first. That’s why we offer a ‘Pay After Placement’ program, where the financial risk is entirely on us. This allows you to concentrate on enhancing your skills and knowledge without the stress of high upfront fees. Focus on mastering the field of clinical research, and only pay once you’ve secured a job. Start your journey with us today—your future begins here!
Risk-Free Learning
You only pay registration fee and rest once you’ve secured a job, minimizing financial risk and ensuring the training delivers real results.
Guaranteed Placement
You pay the remaining fee only after landing a job, ensuring that your investment directly results in employment, providing peace of mind and financial security.