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12 months \u00b7 classroom

PG Diploma in Clinical Research in Pune

iLearn CRI's 12-month PG Diploma in Clinical Research covers ICH-GCP, CRA, pharmacovigilance, clinical data management, regulatory affairs, and medical writing — comprehensive industry training with placement support across Pune CROs.

Duration
12 months
Mode
classroom
Fees
\u20b91.7L

Why the PG Diploma is the most flexible clinical research credential

The PG Diploma in Clinical Research is the most comprehensive credential we offer. Twelve 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; six-month 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 6-month courses don’t

The 6-month 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 12 months are structured

The first two months cover foundations — drug development, ICH-GCP E6(R3), Indian and global regulatory frameworks. This is the conceptual base everything else builds on.

Months 3–4 focus on CRA skills — site monitoring, SDV, RBQM, TMF/ISF management, with hands-on Veeva Vault CTMS and Medidata Rave training.

Months 5–6 shift to pharmacovigilance — ICSR processing, MedDRA and WHO-DD coding, Argus hands-on, aggregate reports, and signal detection.

Months 7–8 cover clinical data management — CDM lifecycle, EDC platforms, CDISC standards (CDASH, SDTM, ADaM), and SAS programming for clinical data.

Months 9–10 build regulatory affairs competence — CTD/eCTD, CDSCO submissions, USFDA and EMA pathways, DMFs, and post-approval lifecycle management.

Month 11 covers medical writing practice — CSR sections, protocol writing, patient narratives, and a manuscript draft.

Month 12 is 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 six weeks of focused, hands-on training that matches our specialised 6-month course depth at 70% completeness.

By month 12, 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 month 12.

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.

Curriculum

What you\u2019ll learn, module by module.

  1. 01 Clinical Research Foundations (Month 1-2)
    • Drug development lifecycle: discovery to post-marketing
    • Phases of clinical trials I-IV in depth
    • Stakeholder ecosystem: sponsor, CRO, site, IRB/IEC, regulators
    • ICH-GCP E6(R3) — full curriculum
    • Indian regulatory framework: NDCT Rules 2019, Schedule Y
    • Global regulatory landscape: USFDA, EMA, MHRA, PMDA, NMPA
  2. 02 Clinical Research Associate Skills (Month 3-4)
    • Site selection, qualification, and initiation
    • Site monitoring visits: SIV, RMV, COV
    • Source Data Verification (SDV) techniques
    • Risk-Based Quality Management (RBQM)
    • Trial Master File (TMF) and Investigator Site File (ISF)
    • Veeva Vault CTMS and Medidata Rave hands-on
    • Protocol deviation management
  3. 03 Pharmacovigilance Practice (Month 5-6)
    • ICSR processing lifecycle
    • MedDRA and WHO-DD coding
    • Argus Safety Database hands-on
    • ARISg overview
    • Aggregate reports: PSUR, PBRER, DSUR
    • Signal detection and disproportionality analysis
    • Risk Management Plans
  4. 04 Clinical Data Management (Month 7-8)
    • CDM lifecycle: study build to database lock
    • EDC platforms: Medidata Rave hands-on
    • CDISC standards: CDASH, SDTM, ADaM
    • SAS programming for clinical data
    • Discrepancy management and reconciliation
    • Database lock procedures
  5. 05 Regulatory Affairs Essentials (Month 9-10)
    • CTD/eCTD structure and submission lifecycle
    • CDSCO submission workflow (SUGAM)
    • USFDA pathways: IND, NDA, ANDA
    • EMA marketing authorisation procedures
    • Drug Master Files and ASMF
    • Post-approval lifecycle management
  6. 06 Medical Writing Practice (Month 11)
    • Clinical Study Report (CSR) structure
    • Protocol writing — SPIRIT guidance
    • Patient narratives for SAEs
    • Manuscript and abstract writing
    • Plain-language summaries
  7. 07 Career Specialisation & Placements (Month 12)
    • Specialisation pathway selection (CRA, PV, CDM, RA, MW)
    • Resume calibration and portfolio building
    • Mock interviews — domain-specific
    • Pune CRO and pharma landscape briefings
    • Direct hiring partner introductions
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
Placements

Where careers actually start.

Our placement record reflects what most institutes don\u2019t measure: not just where you start, but how fast you grow.

Alumni placed across pharma
500+

Alumni placed across pharma and CROs

Average starting CTC for
₹4.2L

Average starting CTC for graduates

Placement rate within 6
92%

Placement rate within 6 months of completion

Pharma & CRO hiring
50+

Pharma & CRO hiring partners in Pune

FAQ

Questions about the PG Diploma in Clinical Research

Can\u2019t find your answer? Reach out on WhatsApp\u2014we usually reply within an hour during business days.

Ask on WhatsApp \u2192
Who should take the PG Diploma vs a specialised 6-month 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 6-month 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 12-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 6-month specialised 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.