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6 months · Offline / Online

PG Diploma in Clinical Research (PGDCR) in Pune

iLearn CRI's PG Diploma in Clinical Research in Pune is a 6-month comprehensive programme covering ICH-GCP, pharmacovigilance, clinical data management, regulatory affairs, and medical writing. ₹65,000 + GST with EMI. Multiple-offer placement support across Pune CROs.

Duration
6 months
Mode
Offline / Online
Fees
₹65K

Why the PG Diploma is the most flexible clinical research credential

The PG Diploma in Clinical Research is the most comprehensive credential we offer. Six months covering every major clinical research domain — CRA, pharmacovigilance, clinical data management, regulatory affairs, and medical writing — designed for graduates who want broad exposure before specialising, and for employers who want hires with cross-functional understanding.

It is also the credential that gives graduates the most negotiating leverage at placement time. A PG Diploma graduate can credibly interview for any clinical research role; specialised-course graduates are typically locked to one track. That optionality often translates into multiple offers and a better-fit final placement.

For B.Pharm, M.Pharm, B.Sc Life Sciences, BDS, MBBS, and BPT graduates entering the field, the PG Diploma is the safest bet when you’re still deciding which clinical research specialisation suits you best.

What does the PG Diploma cover that the specialised courses don’t

The specialised courses (CRA, Pharmacovigilance, CDM, Regulatory Affairs, Medical Writing) go deeper into one domain. The PG Diploma trades some depth for breadth — and adds three things the specialised courses cannot:

Cross-domain context. A CRA who understands what data managers do escalates better. A medical writer who has worked with pharmacovigilance writers writes better DSURs. A regulatory affairs associate with CDM exposure designs better submission strategies. These cross-domain skills compound for the entire career.

Specialisation deferred. Most graduates entering clinical research don’t know whether they prefer field work (CRA), analytical work (CDM), writing (MW), regulatory strategy (RA), or safety (PV) until they have hands-on exposure. The PG Diploma lets you experience all five before choosing.

Multiple offers at placement. PG Diploma graduates routinely receive offers across 2–3 different role types. This drives both the choice quality and the negotiation leverage.

How the 6 months are structured

The 21 modules run in five stages, each assuming the one before it. You do not touch trial documentation until you understand what a trial is for, and you do not choose a specialisation until you have worked in all of them.

Stage A — Scientific foundations (weeks 1–4). What a medicine is, how it acts on the body, and how it gets discovered: clinical research basics, pharmacology and mechanism of drug action, drug discovery and development.

Stage B — Ethics, regulation & the team (weeks 5–8). The tragedies that built the rulebook, the guidelines that resulted, and who does what: the historical and ethical framework, ICH-GCP E6(R3) and global regulators, and stakeholder roles from sponsor to CRA.

Stage C — Running the trial (weeks 9–15). Documentation, methodology, study design, data management, safety and quality — the operational core every clinical research role draws on, including pharmacovigilance (ICSR, SAE timelines, signal detection) and clinical data management (eCRF, IWRS, database lock).

Stage D — Specialist domains (weeks 16–21). Pharmacoeconomics, medical device trials, medical writing for trials and regulatory submission, virtual and decentralised trials, the latest regulatory updates, and AI in clinical research.

Stage E — Industry readiness (weeks 22–24). Placement mastery, real industry case studies, and a mentor-supervised capstone project — running concurrently with specialisation selection and placement preparation: domain-specific resume calibration, mock interviews tailored to the chosen track, and direct hiring partner introductions.

What makes this PG Diploma different

Most PG Diplomas in India trade depth for length — they cover everything superficially without building real working competence in any domain. Our PG Diploma is structured so that each domain gets a focused month of hands-on training that reaches roughly 70% of our specialised-course depth.

By the final month, you have real working competence across all five domains, hands-on portfolios in EDC, Argus, eCTD, and CDM tools, and a clear specialisation path chosen with full information.

The faculty rotates by domain — every module is taught by a practicing professional in that domain (a Senior CRA for the CRA module, a Senior Regulatory Manager for RA, a Senior Medical Writer for MW). You are never taught a domain by someone who isn’t actively practicing in it.

Placement outcomes

PG Diploma placement rate is 95% within 4 months of completion. Average starting CTC of ₹4.2 LPA. Multiple-offer rate (graduates receiving 2+ offers across different role types) is approximately 60% — significantly higher than specialised course graduates.

The placement team works with our full network of 50+ pharma and CRO hiring partners across Pune, with structured introductions tailored to the specialisation track each graduate chooses in the final month.

Apply for the next batch

PG Diploma batches begin twice a year (January and July) at our Wakad campus, with batch sizes capped at 30 students. The course runs weekday evenings (6–9 PM) and full Saturdays. Reach out on WhatsApp to discuss your background and the next intake batch.

Specialised alternatives

If you have already decided on a specific clinical research specialisation rather than the broad PG Diploma credential, the specialised courses go deeper into one domain:

Further reading

Online & classroom

Available online and in the classroom

The PG Diploma in Clinical Research course runs as two separate batches — a live online batch and an offline classroom batch at our Wakad campus — so you can train from anywhere in India or attend in person in Pune. Both run weekday evenings and full Saturdays, and both are fully instructor-led by practicing professionals.

Live online batch

Fully instructor-led live sessions with independent remote hands-on access to the same platforms (Argus, Medidata Rave, eCTD tools) and the same placement support — so you build a real portfolio from home. Designed for students across India and working professionals who can't relocate to Pune.

Classroom batch (Pune)

In-person at our Wakad campus in the Hinjewadi-Wakad corridor, with hands-on lab access and face-to-face faculty time — ideal for Pune-based students who want maximum platform practice.

Not sure which batch suits you? Talk to admissions about the current schedule, or see all online clinical research courses.

Curriculum

What you’ll learn, module by module.

  1. 01 Introduction to Clinical Research
    • Definition and history — the basics
    • The clinical research industry and how it is structured
    • Clinical research versus clinical trials
    • Clinical research terminology
    • General medical terminology
  2. 02 General Pharmacology & Mechanism of Drug Action
    • Basics of pharmacology; branches of pharmacy
    • History of pharmacy
    • The Indian pharmaceutical industry
    • Pharmacodynamics and pharmacokinetics
    • Routes of drug administration
    • Dosage forms
  3. 03 Drug Discovery & Drug Development
    • History of drug discovery
    • The drug discovery process
    • Target identification
    • Lead identification and lead optimisation
    • Discovery genomics
    • Preclinical studies
  4. 04 Historical Perspectives & Evolution of the Ethical and Regulatory Framework
    • The Nuremberg Code, 1947
    • The Declaration of Helsinki
    • The thalidomide tragedy
    • The Belmont Report
    • Schedule Y
    • Drugs and Cosmetics Act, 1940 & Rules, 1945
    • History of the ICH
  5. 05 Ethical Issues in Clinical Research
    • ICH guidelines: ICH-GCP E6(R2) and E6(R3)
    • ICMR ethical guidelines
    • Ethics of placebo use in clinical trials
    • CDSCO and ICMR — India
    • USFDA (USA) and EMA (Europe)
    • MHRA (UK) and TGA (Australia)
  6. 06 Stakeholders & Core Team: Roles and Responsibilities
    • Investigator — roles and responsibilities
    • Sponsor — roles and responsibilities
    • Contract Research Organisation (CRO)
    • Ethics committee (IRB / IEC)
    • Regulatory agencies: USFDA, EMA, CDSCO
    • Clinical Research Coordinator (CRC)
    • Clinical Research Associate (CRA)
  7. 07 Clinical Research Documentation
    • Essential documents before, during and after the trial — ICH-GCP
    • The protocol
    • Informed consent documents
    • Investigator's Brochure
    • Case Report Form
    • Clinical Study Report
  8. 08 Research Methodology & Applied Biostatistics
    • Defining the research problem
    • Sampling design
    • Hypothesis testing
    • Parametric and non-parametric tests
    • Scientific writing
  9. 09 Types and Designs Used in Clinical Research
    • Diagnostic and treatment trials
    • Interventional and observational studies
    • Case-control and cohort studies
    • Randomised controlled trials
    • Quasi-experiments
  10. 10 Clinical Trial Data Management
    • Introduction to data management
    • Electronic data records
    • eCRF and Interactive Web Response Systems
    • Database locking and unlocking
    • Good documentation practices
  11. 11 Pharmacovigilance & Safety Monitoring
    • Adverse drug reactions
    • Serious Adverse Events (SAE)
    • SAE reporting timelines
    • Pharmacovigilance methods
    • Signal detection and data mining
    • PvPI — Pharmacovigilance Programme of India
    • Risk Management Plans
  12. 12 Quality Assurance & Quality Control in Clinical Trials
    • Introduction to Quality Management Systems
    • Quality assurance
    • Quality control
    • Audits and inspections
    • Types of audit
    • General audit observations
  13. 13 Pharmacoepidemiology & Pharmacoeconomics
    • Pharmacoepidemiology — methods
    • Clinical application of pharmacoepidemiology
    • Principles of pharmacoeconomic analysis
    • Pharmaceutical outcomes evaluation
  14. 14 Medical Device Clinical Trials (MDCTs)
    • Medical Devices Rules, 2017
    • Classification of medical devices
    • Materiovigilance
    • Phases of medical device clinical trials
  15. 15 Medical Writing for Trials & Regulatory Submission
    • Case reports
    • Article writing
    • Designing the clinical trial protocol
    • CRF design
    • Informed consent documents
    • Clinical Study Reports
  16. 16 Virtual & Decentralised Clinical Trials
    • E-consent, including audio-visual consent
    • Electronic patient-reported outcomes (ePRO)
    • Interactive Web Response Systems (IWRS)
    • Telemedicine in trial conduct
    • Patient e-diaries
    • Remote patient monitoring
  17. 17 Clinical Trials — Latest Updates (2019 to date)
    • ICH-GCP E6(R3)
    • NDCT Rules 2019 and the 2023 amendment
    • ICMR — HMSC
    • Recent CDSCO notices
    • NABH ethics committee standards
  18. 18 Artificial Intelligence in Clinical Research
    • Introduction to AI
    • Evolution of AI in healthcare
    • Machine learning basics
    • Deep learning
    • Healthcare data types, databases and software
    • Modern clinical trial design
    • Applications across clinical research
  19. 19 Placement Mastery
    • Resume building
    • Communication skills, aptitude and soft skills
    • Corporate etiquette
    • Interview preparation
    • Four mock interviews
  20. 20 Industry-Based Case Studies
    • Real trial scenarios worked end to end
    • Protocol deviations and how teams resolved them
    • Audit findings and corrective actions
    • Safety escalations from the practitioner's seat
  21. 21 Capstone Project
    • An individual project across a chosen domain
    • Supervised by a practising faculty mentor
    • Written deliverable plus presentation
    • Becomes your interview portfolio piece
Career outcomes

Roles graduates step into.

  • Clinical Research Associate
    Avg. CTC ₹ 4.0–5.5 LPA
  • Pharmacovigilance Associate
    Avg. CTC ₹ 3.6–4.5 LPA
  • Clinical Data Coordinator
    Avg. CTC ₹ 3.6–4.5 LPA
  • Regulatory Affairs Associate
    Avg. CTC ₹ 3.5–4.5 LPA
  • Associate Medical Writer
    Avg. CTC ₹ 4.5–6.5 LPA
  • Clinical Trial Coordinator
    Avg. CTC ₹ 3.6–4.5 LPA

PG Diploma in Clinical Research by city

Taught at our Pune campus, with placement support for students across India's pharma hubs.

Salary outlook

What this career pays, fresher to senior, across Indian cities.

Placements

Where clinical research careers start in Pune.

Our placement record reflects what most clinical research institutes in Pune don’t measure: not just where you start, but how fast you grow inside pharma and CROs.

Alumni Working Across Pharma
50+

Alumni Working Across Pharma & CRO Industry

Average Industry Starting CTC
₹4.2L

Average Industry Starting CTC

Placement Assistance Support
100%

Placement Assistance Support

Pharma & CRO Hiring
50+

Pharma & CRO Hiring Partners

FAQ

Questions about the PG Diploma in Clinical Research

Can’t find your answer? Reach out on WhatsApp—we usually reply within an hour during business days.

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What certification does the PG Diploma award? Is it recognised?

You receive the iLearn CRI Post Graduate Diploma in Clinical Research certificate — the institute's most comprehensive credential, identical for online and classroom batches. Pune CRO and pharma employers recognise it in hiring because of what sits behind it: six months of hands-on portfolios across Argus, ARISg, Medidata Rave, Veeva Vault CTMS, and eCTD tools. It is an industry credential, not a university degree — see our PG Diploma vs MSc guide for that comparison.

What is the fee for the PG Diploma in Clinical Research in Pune?

The 6-month PG Diploma in Clinical Research at iLearn CRI in Pune is ₹65,000 + 18% GST. The fee covers all course materials across the pharmacovigilance, CDM, regulatory affairs, and medical writing modules; hands-on platform access (Argus, ARISg, Medidata Rave, Veeva Vault CTMS, and eCTD tools); and structured placement preparation across all specialisation tracks. EMI options are available — most students opt for a 2- or 3-installment plan spread across the 6 months.

Who should take the PG Diploma vs a specialised course?

The PG Diploma is for graduates who want comprehensive exposure across all major clinical research domains before specialising — typically because they're unsure which specific career (CRA, PV, CDM, RA, MW) suits them, or because they want a broader skill base for future career mobility. The shorter specialised courses are for graduates already certain about their path. Both lead to placement, but the PG Diploma graduates often have more employer optionality at the offer stage.

Is the PG Diploma recognised by employers?

Yes. Pune CRO and pharma employers recognise the PG Diploma as the most comprehensive iLearn CRI credential. The six-month duration plus the breadth of hands-on platform training (Argus, Medidata Rave, Veeva Vault, eCTD tools) means PG Diploma graduates often start one band higher than specialised-course graduates and have wider role options.

Can I work part-time during the PG Diploma?

The programme runs weekday evenings (6–9 PM) and full Saturdays, designed to allow continuation of part-time work. Many students hold part-time pharmacy or laboratory work during the diploma. The course load is heavy (assignments and platform practice) so full-time work is not advisable for most students, but part-time and freelance work is manageable.

What is the placement rate for the PG Diploma?

Our PG Diploma placement rate is 95% within 4 months of completion, with average starting CTC of ₹4.2 LPA. The breadth of training means PG Diploma graduates typically have offers from multiple specialisation tracks (CRA, PV, CDM) and can choose the role that best fits their interests and long-term career goals.

Will I become a specialist in any one area?

The PG Diploma builds working competence in all five major domains (CRA, PV, CDM, RA, MW). For deep specialisation in one area, graduates typically build that expertise on the job over the first 12–18 months. The breadth of the diploma is the strength — you can credibly interview for any clinical research role and choose the best offer rather than being locked to one path.