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NewAdvanced postgraduate diploma · 10 months · Dual certification

APGDCR — Advanced PG Diploma in Clinical Research

One diploma across every clinical research function. Start with pharmacology and drug development, then learn clinical trial management, data management, pharmacovigilance, medical writing, regulatory affairs, Clinical SAS and biostatistics. Finish with a capstone and a one-month internship on the PvEdge drug safety database.

10 monthsIncl. 1-month PvEdge internship

Mon–Fri10:00 AM–12:30 PM IST

₹64,999 ₹72,000All-inclusive · launch offer

LifetimeLMS access

Next batch: date TBC · Seats per batch: TBC

Included with APGDCR

Blockchain-based course certification

Hands-on PV training + certificate

Access to placement software tool

Get the APGDCR brochure and a call

A counsellor will call you back within one working day.

10-digit Indian mobile number

Free, no obligation. Counsellors call Mon–Sat, 9:30 am–6:30 pm.

Curriculum

Eight modules and a PvEdge internship, over 10 months.

Taught through live classes, case studies, software workshops and assignments.

01

Pharmacology & drug development

Module 1 · 1 month

02

Clinical trial management

Module 2 · 1.5 months

03

Clinical data management

Module 3 · 1 month

04

Pharmacovigilance

Module 4 · 1.5 months

05

Medical writing

Module 5 · 1 month

06

Regulatory affairs

Module 6 · 1 month

07

Clinical SAS & biostatistics

Module 7 · 1 month

08

Capstone & job readiness

Module 8 · 0.5 month

09

PvEdge internship / project

Internship · 1 month

MODULE 01 · PHARMACOLOGYM1Therapeutic window ConcentrationTime Cmax Absorption Elimination

Module 1 of 8 · Month 1

Pharmacology & drug development

The science every role builds on: how medicines work and how they reach patients.

  • Pharmacokinetics and pharmacodynamics
  • Drug classes and mechanisms of action
  • Adverse drug reactions
  • Drug discovery to approval
  • Preclinical studies
  • Phases of clinical trials

Taught throughLive classes · Case studies · Quizzes

Leads toA strong base for every clinical research role

MODULE 02 · CLINICAL TRIAL MANAGEMENTM2Study CI-301 · Site 04Monitoring visit 3 of 6 1Protocol2Consent3Monitoring4Close-out

Module 2 of 8 · Months 2–3

Clinical trial management

How a new drug is tested in people, and how trials stay safe, ethical and compliant.

  • ICH-GCP and ethics
  • Study design and protocols
  • Informed consent
  • Site monitoring, audits and QA
  • CTMS and eTMF
  • New Drugs and Clinical Trials Rules, 2019

Taught throughLive classes · Case studies · Assignments

Leads toClinical research coordinator · CRA

MODULE 03 · CLINICAL DATA MANAGEMENTM3eCRF · Visit 2 Query resolved

Module 3 of 8 · Months 3–4

Clinical data management

Capture, clean and lock the data every trial depends on.

  • Data management plans
  • EDC systems
  • CRF design
  • Data validation and queries
  • Coding and dictionaries
  • CDM and CDISC standards

Taught throughLive classes · Case studies · Assignments

Leads toClinical data associate

MODULE 04 · PHARMACOVIGILANCEM4–M6ICSR #1042Hepatic · non-seriousICSR #1043Rash · seriousICSR #1044Nausea · non-serious Signal detectionDisproportionality · weekly review Signal

Module 4 of 8 · Months 4–6

Pharmacovigilance

Detect, assess and report drug safety issues once medicines reach patients.

  • PV regulations and PvPI
  • ADR reporting and case processing
  • MedDRA coding
  • Signal detection
  • Aggregate reports (PSUR / PBRER)
  • PvEdge safety database practice

Taught throughLive classes · PvEdge practice · Assignments

Leads toDrug safety associate

MODULE 05 · MEDICAL WRITINGM6–M7ProtocolICFCSRNarrativeICH E3 QC passed

Module 5 of 8 · Months 6–7

Medical writing

Write the documents that start, run and report a clinical trial.

  • Protocols and investigator’s brochures
  • Informed consent forms
  • Clinical study reports (ICH E3)
  • Safety narratives
  • Lay summaries
  • Publications and referencing

Taught throughLive classes · Writing exercises · Feedback

Leads toMedical writer (associate)

MODULE 06 · REGULATORY AFFAIRSM7–M8Module 5 · Clinical study reportsModule 4 · Nonclinical reportsModule 3 · QualityModule 2 · SummariesModule 1CDSCOUS FDAEMASUBMITTED

Module 6 of 8 · Months 7–8

Regulatory affairs

Get trials and new medicines approved in India and abroad.

  • CDSCO and DCGI processes
  • US FDA and EMA pathways
  • CTD structure
  • eCTD submissions
  • Labelling
  • Post-approval changes

Taught throughLive classes · eCTD workshop · Assignments

Leads toRegulatory affairs associate

MODULE 07 · CLINICAL SAS & BIOSTATISTICSM8–M9data adsl;  set sdtm.dm;proc means data=adsl;  class trtp;  var aval;run; p < 0.05

Module 7 of 8 · Months 8–9

Clinical SAS & biostatistics

Turn trial data into the tables and results regulators review.

  • Descriptive and inferential statistics
  • Hypothesis testing and p-values
  • Sample size basics
  • Base SAS: DATA and PROC steps
  • CDISC SDTM and ADaM basics
  • Tables, listings and figures (TLFs)

Taught throughLive classes · SAS labs · Assignments

Leads toClinical SAS programmer (trainee) · Biostatistics support

MODULE 08 · CAPSTONE & JOB READINESSM9Capstone checklistSimulated trial projectProtocol to safety reportCV and LinkedIn reviewMock interview panel Job ready

Module 8 of 8 · Month 9

Capstone & job readiness

Put every module together and prepare for interviews.

  • Simulated trial project
  • Protocol to safety report
  • CV and LinkedIn review
  • Mock interviews with industry panels
  • Pre-Recruitment Training (PRT)
  • Placement support

Taught throughProject work · Mock interviews

Leads toYour first role in clinical research

INTERNSHIP · PVEDGEM10PvEdge · Case processing CASE IDEVENT (MEDDRA PT)SERIOUSNESSSTATUSCASE-2041HepatotoxicitySeriousCASE-2042RashNon-seriousCASE-2043AnaphylaxisSeriousNewCodedSubmitted

Internship · Month 10

PvEdge internship / project

Work on PvEdge full time and finish with a project you can show employers.

  • End-to-end case processing on PvEdge
  • Case intake and triage
  • MedDRA coding and narratives
  • Quality review of cases
  • ICSR preparation
  • Project report and presentation

Taught throughMentor-guided project on PvEdge

Leads toDrug safety associate · PvEdge certificate

Hands-on PV training · included in APGDCR

Train on PvEdge®, a real drug safety database

PvEdge is cloud-based pharmacovigilance software built by Sarjen Systems for pharma, vaccine and medical device safety teams, designed to meet 21 CFR Part 11 and GxP requirements. You use it in the Pharmacovigilance module, then spend the final month on a PvEdge internship / project, processing adverse event cases from start to finish the way a drug safety associate does on the job.

What you will do on PvEdge
  1. Case intake and triageReceive adverse event reports and decide seriousness and reporting timelines.
  2. Case entry and processingEnter patient, drug and event details into the safety database.
  3. MedDRA codingCode events and medical history to the right MedDRA terms.
  4. Narrative writing and quality reviewWrite case narratives and check cases before they are submitted.
  5. ICSR reportingPrepare expedited individual case safety reports for regulators.
  6. Literature review and signal detection basicsSee how safety teams screen literature and spot new safety signals.
How it helps your career
  • Answer interview questions with real case-processing experience, not just theory
  • Add “Hands-on: PvEdge drug safety database” to your CV
  • Get up to speed faster in your first drug safety associate role
  • Understand the compliance rules that shape everyday PV work
  • Show recruiters a second, PV-specific certificate
Dual certification

Graduate with two certificates

Clini IndiaAdvanced PG Diploma in Clinical ResearchIssued by Clini India on completing all modules, the capstone and the final assessment. Blockchain-verified through CredSure.
PvEdgePvEdge hands-on training certificateIssued by PvEdge on completing the drug safety database training and the one-month PvEdge internship / project.

Hands-on training

Work on real industry tools before your first interview

Theory gets you shortlisted. Practice gets you hired. APGDCR students work on PV, CTMS and eTMF systems across the program.

PV database · case entry

Clinical research professional reviewing trial reports

Core workshop

PvEdge drug safety database: case entry, coding and reporting

Enter, code and report adverse event cases the way drug safety teams do.

CTMS tool introduction

Track sites, visits and milestones in a clinical trial management system.

eTMF workshop

File and maintain the essential documents of a trial.

eCTD submission walkthrough

See how a regulatory dossier is structured and submitted.

Clinical SAS labs

Write SAS programs and produce tables, listings and figures from trial data.

Mock interviews with industry panels

Rehearse the questions CROs and pharma companies ask.

Eligibility

Who can join APGDCR

Graduates and postgraduates from these fields can apply.

Pharmacy

  • B.Pharm
  • M.Pharm
  • Pharm.D

Life sciences

Biotechnology, microbiology, biochemistry, nursing and related subjects

  • B.Sc
  • M.Sc
  • PhD

Engineering

Biotechnology or biomedical engineering

  • BE
  • B.Tech
  • M.Tech

Medical & allied health

  • MBBS
  • BDS
  • BAMS
  • BHMS
  • BPT
  • MPT

Fees & batches

Fee, schedule and upcoming batches

Monday to Friday

APGDCR weekday batch

MTWThFSaSu

StartsDateTiming10:00 AM–12:30 PM ISTDuration10 monthsModeOnline live

Every class is recorded on the LMS, so you can catch up if you miss one.

Careers

Roles APGDCR prepares you for

Six entry roles across five job families. Pay shown is the industry-average starting range.*

₹2.4–3.6 LPA

Clinical research coordinator

Runs day-to-day trial activities at a hospital or site

₹2L₹3.5L₹5.5L

₹3.5–5 LPA

Clinical research associate

Monitors sites for protocol and GCP compliance

₹2L₹3.5L₹5.5L

₹2.8–4 LPA

Clinical data associate

Validates trial data and resolves queries

₹2L₹3.5L₹5.5L

₹3–4.5 LPA

Drug safety associate

Processes adverse event cases on a PV database

₹2L₹3.5L₹5.5L

₹3.5–5 LPA

Medical writer (associate)

Drafts study documents and safety narratives

₹2L₹3.5L₹5.5L

₹ range TBC

Regulatory affairs associate

Prepares and tracks regulatory submissions

₹2L₹3.5L₹5.5L

Where it leads

  1. Entry roleAssociate / coordinator
  2. 2–4 yearsSenior associate · Lead
  3. 5+ yearsClinical research manager · Project manager · Specialist track

*Salary figures are industry averages, not Clini India outcomes. See salary and career prospects.

Clini India alumni

From the classroom to the CRO floor

Sanjana, Clini India alumni placed at IQVIA

Watch video

From Clini India to IQVIA: watch Sanjana’s placement story.

SSanjanaPlaced at IQVIA · Clini India alumni

Hrishikesh Vishwakarma, Clini India alumni placed at IQVIA

Watch video

From Clini India to IQVIA: watch Hrishikesh Vishwakarma’s placement story.

HVHrishikesh VishwakarmaPlaced at IQVIA · Clini India alumni

Dona S, Clini India alumni placed at IQVIA

Watch video

From Clini India to IQVIA: watch Dona S’s placement story.

DSDona SPlaced at IQVIA · Clini India alumni

Vivek Pawar, Clini India alumni placed at IQVIA

Watch video

From Clini India to IQVIA: watch Vivek Pawar’s placement story.

VPVivek PawarPlaced at IQVIA · Clini India alumni

FAQ

APGDCR questions

How long is APGDCR, and when are classes?

Ten months in total: nine months of live classes, Monday to Friday, 10:00 AM to 12:30 PM IST, followed by a one-month internship / project on the PvEdge drug safety database. Every class is recorded on the LMS.

Classes run on weekday mornings, 10:00 AM to 12:30 PM IST. If you miss a class, you can catch up through the LMS recordings. Talk to a counsellor about your schedule before you enrol.

APCRM™ covers four modules in four months. APGDCR runs for ten months and adds pharmacology and drug development, regulatory affairs, Clinical SAS and biostatistics, a capstone project and a one-month PvEdge internship, and leads to a postgraduate diploma.

Yes. APGDCR comes with dual certification: the Advanced PG Diploma from Clini India, and a hands-on training certificate from PvEdge after you complete the PvEdge training and assessment.

The full fee is ₹72,000, all-inclusive; the launch offer is ₹64,999, all-inclusive. It covers live classes, lifetime LMS access, study material, PV software, CTMS and eTMF practice, the capstone project, dual certification (Clini India and PvEdge) and placement support.

No. Clini India provides Pre-Recruitment Training and placement support, but does not guarantee a job, interview or internship. Please read the placement policy.

Start APGDCR in the next batch. Talk to a counsellor.

Check your eligibility, pick a batch and ask about instalments, on one free call.

Salary figures are industry averages. Clini India does not guarantee job / interview / internship in any form. Please refer to the placement policy.