💬
AI-Powered Clinical Research & Certification Program

Build a Career in
Clinical Research

Learn how modern clinical operations are becoming AI-assisted while gaining practical experience in protocol review, monitoring, risk management, data review, audit readiness, eTMF management, and career preparation.

🚀 Enroll Now → 📋 View Curriculum
🧪
Real Case Studies
Industry-aligned content
📜
GCP Certification
Globally recognised
👩‍⚕️
Expert Faculty
CROs & pharma veterans
💼
Job Assistance
CRO & pharma placements
Clinical research lab Lab analysis Researcher
85%
Placement rate in our
Clinical Research batch
85%
Placement Rate
₹5.2L
Average Starting CTC
20+
CRO & Pharma Partners
4 Mo.
Program Duration
Clinical research training
20+
CRO and pharma
hiring partners
India's growing CRO hub
MED CRO WORLD

How Modern Clinical Operations
Are Becoming AI-Assisted

This program is not about building AI systems or machine learning models. Students learn how to work confidently alongside AI tools, validate outputs, review compliance requirements, and improve clinical research workflows in real-world environments.

📈
High-Growth Industry
India's clinical research industry is growing at 12%+ annually as global pharma companies shift trials to India for cost and scale advantages.
🌍
No Prior Medical Degree Needed
Life sciences, pharmacy, nursing, or even biology graduates can enter this field with the right training — MBBS or PhD.
🏥
Work With Global Pharma
Clinical research associates and coordinators work directly with international pharmaceutical sponsors and cutting-edge drug development programs.
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Multiple Career Paths
From clinical research associate to data management, regulatory affairs, — many specialisations to grow into.
Career Paths

Where This Course Can Take You

Industry-focused AI workflows designed for Clinical Research Associates and Clinical Operations professionals.

🔬
AI Protocol Review
Protocol summarization, endpoint identification, inclusion/exclusion criteria extraction and operational planning..
₹4L – ₹8L LPA
📊
Monitoring Reports
Draft monitoring reports, visit summaries, issue tracking and compliance review.
₹3.5L – ₹7L LPA
⚠️
Deviation Classification
AI-supported protocol deviation classification, severity assessment and CAPA recommendations.
₹4L – ₹8.5L LPA
📋
RBQM & Risk Detection
Risk identification, KRI monitoring, anomaly detection and escalation recommendations.
₹4.5L – ₹9L LPA
✍️
Central Monitoring
Site performance analysis, fraud detection indicators and operational anomaly review.
₹4L – ₹8L LPA
🗂️
Clinical Data Review
Discrepancy detection, missing data identification and automated query drafting.
₹3.5L – ₹6.5L LPA
🗂️
SAE Narrative Drafting
AI-assisted safety narratives, event summaries and reporting support.
₹3.5L – ₹6.5L LPA
🗂️
eTMF Review
Inspection readiness analysis, expiry tracking and missing document detection..
₹3.5L – ₹6.5L LPA
🗂️
Audit Simulations
FDA inspections, sponsor escalations and compliance challenge simulations.
₹3.5L – ₹6.5L LPA
🗂️
Career Preparation
ATS optimization, LinkedIn enhancement, mock interviews and resume development.
₹3.5L – ₹6.5L LPA
About The Program

How Modern Clinical Operations & Are Becoming AI-Assisted

A comprehensive framework for embedding AI-assisted workflows into clinical research training and preparing students for modern clinical operations.

Clinical research course
Clinical Research
Clinical Research & Pharmacovigilance Program
GCP, Clinical Trials, Regulatory Affairs & Drug Safety
₹32,000 incl. GST
or ₹2,900/mo EMI
A comprehensive program covering the entire clinical trial lifecycle — from protocol design and Good Clinical Practice (GCP) to regulatory submissions, data management, and pharmacovigilance. Includes case studies from real trial scenarios and guidance for industry certification exams.
📅 4 Months
⏱ 1 hr/day LIVE
🏫 Offline + Online
🏅 GCP Certification
💼 Job Assistance
GCP GuidelinesClinical Trial DesignCDM & CDISCPharmacovigilanceRegulatory AffairsMedical Writing
Enroll Now → View Curriculum
Month-by-Month

Curriculum Breakdown

Month 1Foundations of Clinical Research
▾
  • Introduction to clinical trials & drug development phases
  • Good Clinical Practice (GCP) guidelines and ICH-GCP
  • Ethics committees, informed consent, and patient rights
  • Roles: sponsor, CRO, investigator, regulatory bodies
Month 2Clinical Trial Operations & Data Management
▾
  • Protocol design and study documentation (CRF, ICF, SOPs)
  • Clinical data management (CDM) and CDISC standards
  • Site monitoring visits and source data verification
  • Case study: simulated site monitoring exercise
Month 3Pharmacovigilance & Drug Safety
▾
  • Adverse event & serious adverse event (SAE) reporting
  • Signal detection and causality assessment
  • Periodic safety update reports (PSURs)
  • Global pharmacovigilance regulations (FDA, EMA, CDSCO)
Month 4Regulatory Affairs & Career Readiness
▾
  • Regulatory submission documents (NDA, ANDA, CTD format)
  • Medical writing fundamentals — protocols & study reports
  • Mock interviews with CRO hiring managers
  • Capstone project: end-to-end trial documentation package
Student Stories

From Life Sciences Grad
to CRO Professional

★★★★★
"I had a BPharm degree but no idea how to enter clinical research. SKY BREAK's program gave me real GCP knowledge and the confidence to clear my CRO interview. Placed within 6 weeks of completing the course."
Anjali Rao
Clinical Research Associate · IQVIA
Clinical Research Batch · 2024
★★★★★
"The pharmacovigilance module was incredibly detailed. My trainer had actually worked at a CRO and explained real adverse event cases. That depth made all the difference in my interview."
Vikram Acharya
Pharmacovigilance Associate · Parexel
Clinical Research Batch · 2024
★★★★★
"As an MSc Biotechnology graduate, I wanted a structured path into the industry. The live classes and capstone project gave me a portfolio I could actually discuss in interviews."
Sowmya Iyer
Clinical Data Coordinator · Syneos Health
Clinical Research Batch · 2025
Hiring Partners

CROs & Pharma Companies
That Hire Our Graduates

IQVIA
Global CRO
Parexel
Global CRO
Syneos Health
Global CRO
ICON plc
Global CRO
Biocon
Biopharma
Dr. Reddy's Labs
Pharma
Sun Pharma
Pharma
+ 13 more
CRO & Pharma
FAQ

Common Questions

Do I need a medical degree to join?+
No. Most roles in clinical research are open to life sciences, pharmacy, nursing, biotechnology, microbiology, and even general science graduates. An MBBS or PhD is not required for CRA, CDM, or pharmacovigilance roles.
What is GCP certification?+
Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing and conducting clinical trials. Our program includes GCP training and certification guidance recognised across the industry.
Can I pursue this alongside a pharmacy or BSc degree?+
Yes — our evening and weekend batches are specifically designed for students and working professionals to pursue this alongside their existing studies or jobs.
What does placement assistance include?+
Resume building tailored for CRO/pharma roles, mock interviews with industry professionals, and direct referrals to our 20+ hiring partners including IQVIA, Parexel, and Syneos Health.
Get Started

Begin Your Clinical
Research Career

Book a free counselling session. Our team will help you understand the curriculum, batch timings, and career outcomes.

🎓
Free Career Counselling
30-minute call to discuss your background and career goals in clinical research.
📄
Detailed Syllabus PDF
Get the complete month-by-month curriculum sent to your email instantly.
💳
EMI from ₹2,900/month
0% interest EMI options available via Razorpay on major debit/credit cards.
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📍 SKY BREAK Academy, Mahadevapura, Bengaluru – 560048

Healthcare Needs Skilled Professionals.
Be One of Them.

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