Clinical Research
Clinical Research
Build a successful career in Clinical Research by learning Clinical Trial Management, Good Clinical Practice (ICH-GCP), Regulatory Affairs, Clinical Data Management, Pharmacovigilance, and Medical Writing through real-world healthcare case studies. A 6-month, fully online industry certification program with 10 modules, 8 industry projects, one 6-month elective track, and dedicated placement support.
This program page reflects our latest curriculum draft. Fees, faculty, and career-support details shown below are the ones on file in our admissions system — figures like guarantees or hiring-partner counts mentioned in course descriptions are illustrative and being finalized. Contact admissions for current details.
Program Details
Format: 6 months, 100% online, live cohorts, sessions recorded for later.
Guarantee: 180-day better-offer guarantee — a better offer within 180 days of completion, or a full refund, backed by a signed legal agreement before you pay.
Admissions process: Shortlist call → Aptitude test → Interview → Offer rollout.
Curriculum Outline
Click any row to expand detailsWhat is clinical research, importance of clinical trials, drug development process, regulatory compliance, career opportunities
Key Topics & Modules
Clinical trial phases, study design, protocol development, patient recruitment, site selection
Key Topics & Modules
ICH-GCP guidelines, investigator responsibilities, ethics committee, informed consent, patient safety
Key Topics & Modules
FDA guidelines, EMA regulations, CDSCO, clinical trial documentation, regulatory submission
Key Topics & Modules
CRF design, data collection, database validation, data cleaning, quality assurance
Key Topics & Modules
Drug safety, adverse events, signal detection, risk management, pharmacovigilance reporting systems
Key Topics & Modules
Clinical study reports, protocol writing, SOP writing, research publications, clinical documentation standards
Key Topics & Modules
Documentation systems, SOP maintenance, quality audits, data privacy in trials, documentation technology
Key Topics & Modules
Choose a real clinical research case study, design a solution, document & present findings, get reviewed by industry experts
Key Topics & Modules
Resume & LinkedIn transformation, portfolio refinement, mock interviews, salary negotiation, placement support
Key Topics & Modules
Choose one: Clinical Trial Operations Track, Regulatory & Data Track, or Medical Writing & Safety Track
Key Topics & Modules
Specialisation Tracks
Clinical Trial Operations Track
Focus areas: Site Management & Monitoring, Trial Coordination & Timelines, Vendor & CRO Management, Trial Operations Playbook, Live Trial Operations Simulation. Career roles: Clinical Research Associate, Clinical Trial Coordinator, Clinical Project Coordinator, Site Operations Associate.
Regulatory & Data Track
Focus areas: Advanced Regulatory Submissions, Global Regulatory Strategy, Clinical Database Architecture, Regulatory Dossier & Data Package, End-to-End Regulatory Submission Project. Career roles: Regulatory Affairs Associate, Clinical Data Associate, Data Management Analyst, Regulatory Strategy Associate.
Medical Writing & Safety Track
Focus areas: Advanced Medical Writing, Pharmacovigilance Casework, Signal Detection & Risk Reporting, Clinical Study Report Portfolio, Drug Safety & Writing Capstone Project. Career roles: Medical Writer, Drug Safety Associate, Pharmacovigilance Associate, Clinical Research Executive.
Tools & Technologies
Gain hands-on proficiency with the actual software, platforms, databases, and computational frameworks standard across leading healthcare and research organizations.
Capstone Projects
Apply your learning to end-to-end, industry-standard portfolio projects modeled on real-world pharmaceutical, clinical, and health-tech workflows.
End-to-End Clinical Trial Protocol & Operations Design
Design a complete Phase II/III clinical trial protocol including patient recruitment strategies, site selection criteria, informed consent workflows, and ICH-GCP compliance documentation.
Electronic Data Capture (EDC) & Database Validation
Build and validate an EDC database in REDCap/Oracle Clinical, design Case Report Forms (CRFs), configure edit checks, and perform data cleaning for a multicenter study.
Pharmacovigilance & Drug Safety Signal Detection
Perform adverse event (AE) reporting, MedDRA coding, signal detection analysis, and compile a Safety Update Report for regulatory review.
Regulatory Dossier & Submissions Strategy
Prepare a comprehensive clinical study dossier for FDA/EMA submission, including protocol amendments, investigator brochures, and audit preparation playbooks.
Program Faculty
Dr. Anjali Mehta
Lead Faculty, Clinical Research
Dr. Anjali Mehta brings 12+ years of industry and teaching experience in Clinical Trial Management.
Career Opportunities
Program Cohorts
Join a structured, mentor-led cohort designed for interactive live learning, hands-on clinical trial case studies, and dedicated placement guidance.
6 Months
Live Online Classes
Live Regular classes on Saturday & Sunday (Choose either 10:00 AM - 12:00 PM or 7:00 PM - 10:00 PM)
Monday to Friday round-the-clock mentor assistance
Strictly capped at 10 students per batch for personalized attention
What You'll Get
- ✓1:1 mentorship
- ✓Unlimited mock interviews and feedback
- ✓Resume & LinkedIn profile transformation
- ✓Portfolio refinement
- ✓Salary negotiation training
- ✓Job referrals and placement support
- ✓350+ hiring partner network
- ✓Capstone project reviewed by industry experts
Who This Is For
- •Bachelor's degree in any discipline
- •Open to professionals, entrepreneurs, and graduates
- •2+ years of experience recommended for management-track roles
Success Stories
Hear from our alumni who have successfully transitioned into rewarding Medivex AI careers.
Ready to start Clinical Research?
Talk to admissions or download the full brochure to see the complete curriculum.