CLINI-MENTOR Series · Advanced Programs

Advance
Diploma Programs

Industry-aligned, ICH-GCP R3 driven curriculum for Clinical Research, eTMF, Pharmacovigilance & Data Management professionals. Making Aspirants Industry Ready.

Advance Diploma in Clinical ResearchClinical Operations · Monitoring · Regulatory Documentation

Advance Diploma in eTMF / Document ManagementTMF Reference Model · ICH E6(R3) · Inspection Readiness · Veeva

Advance Diploma in PharmacovigilanceDrug Safety · ICSR Processing · MedDRA · Signal Detection

Advance Diploma in Clinical Data ManagementEDC Systems · CDISC/SDTM · Query Management · CDM Tools

Months Each

28+

Industry Modules

500+

Placements

Live

+LMS+Mentor

🎓

ICH-GCP R3 Aligned

Latest E6(R3) principles embedded throughout — essential records, QbD, RBQM, distributed records

🏭

Real Industry Exposure

Mock audits, inspection simulations, Veeva Vault walkthroughs & live project exercises

🤝

CLINI-BUDDY Mentorship

1-on-1 dedicated industry expert assigned to every student throughout the journey

🚀

Career Accelerator

ATS Resume · LinkedIn makeover · Mock interviews · Placement assistance via recruiter network

📧 learn@cliniassure.com

📧 clinibuddy@cliniassure.com

📞 +91 94304 47266

🌐 www.cliniassure.com

📋 Navigation

Program Overview — CLINI-MENTOR Series

🎯

Four Industry-Aligned Advance Diploma Programs

Each program runs for 6 months and includes Live Online Sessions, LMS Access, Practical Assignments, Industry Mentor Interactions, and a comprehensive Career Accelerator module. All curricula are aligned with global regulatory standards — ICH E6(R3), FDA 21 CFR, EMA GVP, and CDISC — with real-world industry tools exposure.

Advance Diploma in Clinical Research

End-to-end clinical trial operations — from drug discovery to site close-out. Master monitoring, safety, documentation and GCP compliance.

🔬 6 Modules 72 Topics ICH E6(R3)

Advance Diploma in eTMF / Document Management

TMF Reference Model mastery, metadata, QC, inspection readiness, and Veeva Vault operations. The flagship eTMF program.

📁 10 Modules 120 Topics Veeva Vault

Advance Diploma in Pharmacovigilance

Drug safety science, ICSR processing, MedDRA coding, aggregate reporting, signal detection across global PV frameworks.

🛡️ 6 Modules 72 Topics ICH E2A/E2B

Advance Diploma in Clinical Data Management

CRF design, EDC systems, query management, CDISC/SDTM standards, data cleaning and database lock processes.

💾 6 Modules 72 Topics CDISC/SDTM

Program Delivery Structure

🎥

Live Sessions

Interactive online classes with experienced industry practitioners

💻

LMS Access

Recorded content, study notes, quizzes & assessments on demand

🔬

Practicals

Mock audits, case studies, tool simulations & capstone projects

🤝

CLINI-BUDDY

1-on-1 industry mentor assigned throughout your entire journey

Career Outcomes Across All Programs

🔬 Clinical Trial Assistant 🏥 CRC / CTA 📁 eTMF Associate 📋 TMF Specialist 💊 Drug Safety Associate 🛡️ PV Analyst 💾 Clinical Data Associate 📊 CDM Coordinator 📄 Records Management Associate 🔍 Monitoring Associate 🌐 Clinical Operations Associate 📝 Study Documentation Specialist

Program 01 of 04

Advance Diploma in Clinical Research

🔬 6-Month Program

Live + LMS + CLINI-BUDDY Mentorship

Advance Diploma in Clinical Research

Develop end-to-end understanding of clinical trial operations, compliance, global regulations, documentation, quality management, and practical industry workflows used by Pharma, CRO, and Biotech organizations. Fully aligned with ICH E6(R3) GCP standards.

Understand global clinical trial lifecycle Apply ICH-GCP R3 principles Perform monitoring & site activities Master essential documentation Conduct inspection readiness activities Become clinically operation-ready

Target Career Roles

👩‍🔬 Clinical Trial Assistant 🏥 CRC 📋 CTA 🔍 Clinical Operations Associate 🚀 Study Start-Up Associate 📊 Monitoring Associate

Healthcare & Drug Development Ecosystem

Foundation Module

🌍

Global Healthcare Industry Overview

Healthcare stakeholders, Pharma/CRO/Biotech ecosystem

🧪

Drug Discovery Process

Target identification, lead optimization, preclinical concepts

📈

Drug Development Lifecycle & Phases I–IV

💊

Innovator vs Generic Drugs

🔬

Pre-Clinical Research & IND Process

✅

Drug Approval Process

NDA, BLA, MAA workflows

🏛️

Regulatory Agencies

US FDA, EMA, CDSCO, PMDA, Health Canada

🏠

Decentralized & Hybrid Trial Models

🤖

AI in Clinical Research & Digital Transformation

🎯

Precision Medicine & Biomarker-driven Trials

❤️

Patient Centricity & PROMS

🔮

Future Trends in Clinical Operations

Clinical Research Fundamentals & ICH-GCP

Regulatory & Ethical Framework

🔄

Clinical Trial Lifecycle & Phases

📐

Study Designs

Randomized, observational, adaptive, crossover

🎲

Randomization & Blinding Methods

👥

Stakeholders in Clinical Research

Sponsor, CRO, Investigator, IRB/IEC roles

📜

ICH-GCP E6(R3) — Principles & Evolution

🏗️

Quality by Design (QbD) in Trials

⚠️

Risk-Based Quality Management (RBQM)

⚖️

Ethics in Clinical Research — Belmont / Helsinki

✍️

Informed Consent Process & eConsent

🛡️

Subject Safety & Rights

📋

Protocol Overview & Amendments

📁

Clinical Trial Documentation Overview

Clinical Operations & Site Monitoring

The Engine Room of Clinical Trials

🔍

Site Identification & Feasibility Assessment

✅

Site Selection Criteria & Evaluation

🏁

Site Initiation Visit (SIV) Procedures

👁️

Routine Monitoring Visit Activities

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Source Documentation & Source Data Verification

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Risk-Based Monitoring (RBM) Framework

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Centralized Statistical Monitoring (CSM)

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Site Closeout Visit (COV) Process

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Protocol Deviations: Types & Management

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CAPA — Corrective & Preventive Actions

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Inspection Readiness at Site Level

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Monitoring Reports & Follow-up Letters

Essential Documents & Regulatory Documentation

The Paper Trail of Clinical Research

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Clinical Study Protocol & Amendments

📗

Investigator Brochure (IB)

✍️

Informed Consent Form (ICF) versions

🗂️

Regulatory Binder / Site File Management

⚕️

Safety Documentation — IND Safety Reports

📁

Trial Master File (TMF) Overview

📋

SOPs & Work Instructions

👤

Delegation Logs & Signature/Initials Logs

🎓

Training Records & CV Documentation

🏛️

Site Regulatory Submissions

🔑

ALCOA+ Principles in Documentation

🗄️

Archival Process & Retention Periods

Clinical Safety & Quality Compliance

Protecting Patients Throughout the Trial

⚠️

Adverse Events (AE) — Definition & Classification

🚨

SAE — Serious Adverse Events

Criteria, timelines, regulatory reporting

🔴

SUSAR — Suspected Unexpected SAR Reporting

⚖️

Causality & Severity Assessment

📋

Protocol Deviations vs Violations

🏛️

Regulatory Inspection Process

🔎

GCP Audit Preparation

🔧

CAPA Management & Effectiveness Checks

❌

GCP Violations & Consequences

🏗️

Quality Management Systems (QMS)

🌳

Root Cause Analysis Methods

📊

Risk Assessment in Clinical Operations

Practical Industry Exposure & Capstone

Real-World Simulations & Assessment

📝

Monitoring Report Creation Workshop

🏥

Site Visit Simulation Exercises

💡

Case Scenario Analysis

📄

Real-World Study Documentation Exercises

🚀

Study Start-Up Activity Simulation

🔎

Mock Audit Participation

💻

Industry Tools Exposure

EDC, CTMS, eTMF platform overview

✅

SDV / SDR Exercises

🚨

AE/SAE Reporting Simulation

🤝

Corporate Communication & Professional Etiquette

🏆

Capstone Project Presentation

🎓

Final Assessment & Certification

🔬 Key Practical Components — Program 01

📝 Monitoring Report Writing 🏥 Site Visit Simulation 🔎 Mock GCP Audit ✅ SDV/SDR Exercise 🚨 AE/SAE Reporting 🚀 Study Start-Up Sim 🔧 CAPA Documentation 💻 Industry Tools

Program 02 of 04 · Flagship Program

Advance Diploma in eTMF / Document Management Practices

📁 ICH E6(R3) Driven · 10 Modules

6 Months · Premium Flagship Program

Advance Diploma in eTMF / Document Management Practices

Develop professionals with complete understanding of Trial Master File management, modern eTMF operations, inspection readiness, regulatory expectations, digital document lifecycle, and practical workflows — built around ICH E6(R3) essential records, quality-by-design, metadata, oversight, distributed records, and inspection readiness.

Interpret TMF Reference Model Apply ICH-GCP R3 in document workflows Perform QC, reconciliation & filing Understand metadata & audit trails Operate modern eTMF / Veeva Vault Understand eISF & decentralized records Achieve inspection readiness Qualify for eTMF Associate roles

Target Career Roles

📁 eTMF Associate 📋 TMF Specialist 📄 Clinical Document Coordinator 🗄️ Records Management Associate 🔍 Trial Master File Analyst 📝 Study Documentation Specialist

Clinical Research & Trial Ecosystem

Foundation for eTMF Professionals

🌍

Global Pharma Industry Structure

🏢

CRO Business Models & Sponsor Ecosystem

💊

Drug Development Lifecycle

🔬

Clinical Trial Phases I–IV

📐

Trial Design: Randomization & Blinding

👥

Stakeholders & Investigator Site Structure

🏠

Decentralized & Hybrid Trial Models

🤖

Digital Transformation & AI in Clinical Documentation

📅

Clinical Operations Workflow & Study Milestones

🔮

Future of Clinical Trials

ICH-GCP R3 & Global Regulatory Framework

The Regulatory Foundation of eTMF

🌐

Introduction to ICH & Global Regulatory Bodies

📈

ICH E6 Evolution: R1 → R2 → R3

📜

13 Principles of GCP (E6 R3)

🏗️

Quality by Design (QbD) in Clinical Trials

⚠️

Risk-Based Quality Management (RBQM)

📋

Essential Records Concept — ICH E6(R3)

🔑

Metadata & Data Integrity Requirements

🏢

Sponsor & Vendor Oversight Responsibilities

🌐

Distributed Records Environment

🏛️

Inspection Readiness & Documentation Expectations

Trial Master File (TMF) Foundations

What the TMF is, Why it Exists, How it Works

📁

What is the TMF — Purpose & Regulatory Basis

📋

Essential Records — ICH E6 Definition

🆚

Paper TMF vs Hybrid TMF vs eTMF

🔄

TMF Lifecycle Alignment with Trial Phases

🏢

Sponsor TMF — Structure & Responsibilities

🤝

CRO TMF — Delegated Activities Documentation

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Investigator Site File (ISF)

💻

Electronic ISF (eISF) — Concepts & Expectations

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TMF Plan, Index & Ownership Models

🏛️

Inspection Expectations for TMF

TMF Reference Model Masterclass

Zone-by-Zone Classification Mastery

📖

TMF Reference Model — History & Purpose

📈

Reference Model Evolution & Current Version

🗂️

Zone Structure Overview

Zones 1–11: Trial Management to Study Reports

📂

Sections, Sub-sections & Artifact Mapping

🏷️

Artifact & Sub-artifact Concepts

🔖

Metadata Structure in Reference Model

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Naming Conventions & Standards

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Classification Methods & Filing Taxonomy

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Country / Site / Study Level Documents

🧩

Practical Classification Exercises

Essential Documents Deep Dive

Every Critical Document Explained

📜

Clinical Study Protocol & Amendments

✍️

Informed Consent Form (ICF) & eConsent

📗

Investigator Brochure (IB) Management

🏛️

Regulatory Approvals — IEC/IRB/Health Authority

🏥

Site Documentation Suite

👤

Delegation Logs & Responsibility Matrix

🎓

Training Documentation & GCP Certificates

🚨

Safety Documentation

SUSARs, IND safety reports, DSUR

🤝

Vendor Documentation & Contracts

📋

Monitoring Records, Correspondence & Archival

eTMF Lifecycle Management

End-to-End Document Control

✏️

Document Creation & Authoring Standards

🔄

Review & Approval Workflows

📂

Filing Activities & Classification

🔢

Version Control & Document Supersession

🏷️

Metadata Assignment Standards

🔍

Audit Trail Concepts & Review

✅

Completeness Review Process

⚖️

TMF Reconciliation Activities

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Document Migration & Data Transfer

🗄️

Retention, Archival & Close-out Activities

Metadata, Taxonomy & Data Integrity

The Hidden Engine of eTMF Quality

🏷️

Metadata Concepts & Importance in eTMF

📊

Core Metadata Fields

Study ID, site, country, artifact, sub-artifact, status

🗃️

Taxonomy Principles & Controlled Vocabulary

📝

Document Naming Standards & Conventions

🔑

ALCOA+ Framework in Document Management

🛡️

Data Integrity in Electronic Systems

📜

Audit Trail Review & Requirements

🔗

Traceability, Chain of Custody & Version Tracking

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Duplicate Detection & Resolution

🏛️

Metadata & Document Governance Framework

eTMF Quality Control & Inspection Readiness

Always Ready for Regulatory Scrutiny

✅

QC Process Design & Execution

📊

TMF Health Metrics & KPIs

📋

Completeness Review & Tracking

⚠️

Quality Indicators & Risk Thresholds

❓

Missing Documents Management

🔧

CAPA in Document Management Context

🌳

Root Cause Analysis for TMF Issues

🚨

Inspection Findings — Common Deficiencies

🏥

Audit Preparation & Regulatory Inspection Process

💡

Lessons Learned & Continuous Improvement

Technology Ecosystem & eTMF Platforms

Veeva Vault, 21 CFR Part 11 & Beyond

🏗️

eTMF System Architecture Overview

💻

Electronic Systems & Validation Concepts

📜

21 CFR Part 11 — Electronic Records & Signatures

✅

Computer System Validation (CSV) Basics

🔐

User Access Management & Security

👤

Roles & Permissions in eTMF Systems

⚙️

Workflow Configuration & Automation

☁️

Veeva Vault eTMF — Core Concepts & Navigation

🔗

eISF, System Integration & Cloud Repositories

🤖

Future Technologies — AI in TMF Management

Real-Time Exposure & Capstone Project

Full eTMF Simulation & Assessment

📂

Filing Exercises — Zone-by-zone Practice

✅

QC Activities Simulation

⚖️

Reconciliation Simulation Workshop

🏷️

Metadata Assignment Exercises

📊

TMF Health Review Exercises

🏛️

Inspection Scenario Exercises

🔎

Mock Audit Observation Participation

🔧

CAPA Documentation Practice

📈

TMF Dashboard Interpretation

🏆

Capstone: End-to-End TMF Set-Up & Health Assessment

📁 Key Practical Components — Program 02

📂 Filing Exercises ✅ QC Simulation ⚖️ Reconciliation Workshop 🏷️ Metadata Exercises 🔎 Mock Audit 🔧 CAPA Practice ☁️ Veeva Walkthrough 🏛️ Inspection Readiness

Program 03 of 04

Advance Diploma in Pharmacovigilance

🛡️ 6 Modules · Global PV Standards

6 Months · ICH E2A/E2B/E2C Aligned

Advance Diploma in Pharmacovigilance

Develop competent PV professionals with drug safety science, ICSR case processing workflows, MedDRA coding, global database operations, aggregate reporting, and signal detection — aligned with ICH, EMA GVP, FDA, and global pharmacovigilance regulatory requirements.

Understand drug safety science globally Process ICSRs end-to-end Apply MedDRA coding principles Prepare aggregate safety reports Perform signal detection activities Operate within safety databases

Target Career Roles

💊 Drug Safety Associate 🛡️ PV Analyst 📋 ICSR Processor 🔍 Signal Detection Analyst 📊 Safety Data Coordinator 🏛️ Pharmacovigilance Officer

Drug Safety Foundations & PV Ecosystem

The Global Safety Science Framework

🛡️

What is Pharmacovigilance — Definition & Purpose

🌐

Global PV Regulatory Framework

ICH E2A/E2B(R3)/E2C/E2D/E2E guidelines

👥

PV Stakeholders — MAH, Sponsor, Regulatory Agencies

⚖️

Drug Safety Science & Benefit-Risk Evaluation

🔄

PV in Drug Lifecycle — Pre-clinical to Post-marketing

📡

Signal Concepts — Introduction

📋

MAH PV Obligations & EMA GVP Modules Overview

🏛️

FDA MedWatch, FAERS & QPPV Role

📁

PV System Master File (PSMF)

🔎

PV Audit & Inspection Readiness

Safety Events — Classification & Reporting

AE, SAE, ADR, SUSAR Deep Dive

⚠️

Adverse Event (AE) — Definition & Types

🚨

Serious Adverse Event (SAE) — Criteria & Definitions

🔴

Adverse Drug Reaction (ADR) & SUSAR

⚖️

Severity, Causality & Expectedness Assessment

🏷️

Coding Principles — MedDRA Application

⏱️

Reporting Timelines — 7-day / 15-day

📚

Literature Case Management

📊

Spontaneous Reporting Systems

🤰

Pregnancy, Lactation & Paediatric Cases

💊

Overdose, Medication Error & Special Situations

ICSR Case Processing Workflow

Intake to Submission — End-to-End

📋

ICSR — Individual Case Safety Report Overview

📥

Case Intake & Triage Process

💻

Case Data Entry & Medical Review

✍️

Narrative Writing Workshop

❓

Follow-up Queries & Additional Information

🔍

Duplicate Case Detection & Merging

⚖️

Reconciliation Activities

📚

Literature Surveillance & Case Identification

📡

E2B(R3) — Electronic Transmission Format

📤

ICSR Submission & Archival

MedDRA Coding & Safety Databases

Argus, EudraVigilance, FAERS & VigiBase

🗂️

MedDRA Hierarchy

SOC, HLGT, HLT, PT, LLT structure

🔑

MedDRA Coding Principles, Browser & SMQs

💊

WHO Drug Dictionary — Coding Concepts

💻

Argus Safety — Core Concepts & Navigation

🆚

Oracle Argus vs Veeva Vault Safety Overview

🇪🇺

EudraVigilance & EVWEB

🇺🇸

FDA FAERS Database

🌍

VigiBase — WHO Global Database

🔐

User Access & Database Permissions

✅

Data Entry Quality Standards

Aggregate Reporting & Signal Detection

PSUR, PBRER, DSUR & Signal Management

📊

Aggregate Reporting Overview & Purpose

📅

PSUR — Periodic Safety Update Report

⚖️

PBRER — Periodic Benefit-Risk Evaluation Report

🔬

DSUR — Development Safety Update Report

🗺️

RMP — Risk Management Plan & REMS Overview

📡

Signal Detection Process & Methods

📈

Disproportionality Analysis — PRR, ROR, EBGM

✅

Signal Validation, Assessment & Management

🏷️

Product Label Changes & Variations

⚖️

Cumulative Benefit-Risk Evaluation

Real-Time PV Exposure & Capstone

Case Studies, Simulations & Certification

💊

ICSR Mock Case Processing Exercises

✍️

Narrative Writing Practice

🏷️

MedDRA Coding Practical Exercises

⚠️

Case Triage & Classification Scenarios

💻

Argus System Walkthrough

📊

Aggregate Report Structure Review

📡

Signal Detection Simulation

💡

Industry PV Workflow Case Studies

🔎

Mock PV Audit & Inspection

🏆

Capstone PV Project & Certification

Program 04 of 04

Advance Diploma in Clinical Data Management

💾 6 Modules · CDISC / SDTM Aligned

6 Months · EDC & Database Focus

Advance Diploma in Clinical Data Management

Build comprehensive capability in clinical data lifecycle management — from CRF design and EDC operations to query management, CDISC standards, coding, data cleaning, and database lock — aligned with CDISC, ICH E6(R3), and global regulatory data expectations.

Understand clinical data lifecycle Design CRFs and eCRFs Operate EDC systems Manage queries and data cleaning Apply CDISC/SDTM standards Perform database lock activities

Target Career Roles

💾 Clinical Data Associate 📊 CDM Coordinator 🖥️ EDC Specialist 📐 CRF Designer 📋 Data Standards Associate 🔍 Data Management Associate

CDM Fundamentals & Data Lifecycle

The Foundation of Clinical Data

💾

Clinical Data Management — Scope & Importance

🔄

Clinical Data Lifecycle Overview

👥

CDM Roles & Responsibilities

🗄️

Clinical Databases — Types & Purpose

🔀

Data Flow in Clinical Trials

📄

Source Data & Source Documents

💻

EDC Concepts & Paper vs Electronic Data

🏗️

Study Build & Database Setup

📋

CRF Concepts — Purpose & Types

🤖

AI in Clinical Data Review & Industry Trends

CRF / eCRF Design & Edit Checks

Designing Quality Data Collection Tools

📐

CRF Design Principles & Best Practices

📝

Annotated CRF (aCRF) — Purpose & Structure

💻

eCRF Design & Field Types

🔗

Protocol-to-CRF Mapping

✅

Edit Checks & Validation Rules

🔢

Field Validations — Range, Pattern, Logic

📊

CDISC CDASH Standards in CRF Design

📅

Visit Schedule Design

📋

CRF Review, Sign-off & Completion Guidelines

🧪

UAT — User Acceptance Testing of eCRF

EDC Systems & Database Operations

Medidata, Oracle, Veeva & More

💻

EDC System Overview & Major Platforms

🖥️

Medidata Rave — Concepts & Navigation

🗄️

Oracle Clinical / InForm Overview

☁️

Veeva Vault CDMS Introduction

👤

Data Entry Workflows & User Roles

🏗️

Database Setup & Study Configuration

📥

Data Import & External Data Loading

📱

ePRO / eSource Integration

🔬

Laboratory Data Management

🔒

Audit Trails in EDC & Database Lock Procedures

Query Management & Data Cleaning

Ensuring Data Quality & Integrity

❓

Query Lifecycle — Raise to Close

🔀

Query Types — Manual, Programmatic, CRF

⚠️

Discrepancy Management

🧹

Data Cleaning Plan & Strategy

👁️

Data Review & Monitoring Activities

⚖️

Reconciliation — SAE, Protocol Deviations, Labs

🏷️

Medical Coding Quality Review

📋

Data Management Plan (DMP)

📊

Data Quality Metrics & KPIs

🔒

Database Freeze, Lock & Final Dataset Delivery

CDISC Standards, Coding & Submission

SDTM, ADaM, MedDRA & Regulatory Submission

📊

CDISC Overview — CDASH, SDTM, ADaM

📐

SDTM — Study Data Tabulation Model

🗂️

SDTM Domain Structure & Variables

📈

ADaM — Analysis Data Model Concepts

📝

CDISC Controlled Terminology

🏷️

MedDRA Medical Coding & WHO Drug Dictionary

📋

CDISC Implementation Guide Usage

📤

Data Submission Packages — NDA/BLA/MAA

🔍

Pinnacle 21 Validation Tool Overview

🏛️

FDA/EMA Data Standards Requirements

Practical CDM Exposure & Capstone

Hands-On Exercises & Certification

💾

Mock Dataset Exercises — Entry & Review

📐

eCRF Design Practice Workshop

❓

Query Raising & Resolution Simulation

🧹

Data Cleaning Scenario Exercises

🏷️

MedDRA Coding Practice

⚖️

SAE Reconciliation Exercises

📊

SDTM Mapping Exercises

💻

EDC Platform Walkthroughs

📋

DMP Review & Data Quality Report Preparation

🏆

Capstone: Study Data Management Project & Certification

🚀

Career Accelerator is embedded in every CLINIASSURE program

Providing comprehensive placement preparation, professional branding, mentorship, and industry readiness training to bridge the gap between learning and employment in clinical research, PV, CDM, and eTMF roles. Our recruiter network spans CROs and pharma companies across India — we actively refer and follow up until you land the right role.

📄

ATS Resume Building

🔗

LinkedIn Profile Makeover

💼

Naukri Profile Optimization

🎤

Interview Preparation

🌐

Industry Expert Sessions

💬

Communication Skills

🤵

Corporate Etiquettes

🌟

Personality Development

🧑‍🏫

CLINI-BUDDY Mentorship

🎯

Placement Assistance

CLINI-MENTOR — Mentorship That Transforms

Our mentorship model goes far beyond classroom training. Every student is assigned a dedicated industry expert — your personal CLINI-BUDDY — who guides you through real-world challenges, career planning, and personal development from Day 1 to placement. CLINI-BUDDY mentors provide real-world career guidance, CV reviews, mock interviews, and sector-specific advice tailored to help you land your first role in clinical research, eTMF, pharmacovigilance, or data management.

👤 1-on-1 Career Guidance 🌐 Industry Expert Access 🎤 Mock Interview Sessions 📄 Portfolio Review 🤝 Network Building 🚀 Placement Support

All Programs at a Glance

Program	Duration	Modules	Target Roles	Regulatory Alignment
🔬 Advance Diploma in Clinical Research	6 Months	6 Modules	CTA, CRC, Monitoring Associate	ICH E6(R3), GCP
📁 Advance Diploma in eTMF	6 Months	10 Modules	eTMF Associate, TMF Specialist	ICH E6(R3), 21 CFR Part 11, TMF Ref Model
🛡️ Advance Diploma in Pharmacovigilance	6 Months	6 Modules	Drug Safety Associate, PV Analyst	ICH E2A/E2B/E2C, EMA GVP, FDA
💾 Advance Diploma in Clinical Data Management	6 Months	6 Modules	CDA, CDM Coordinator, EDC Specialist	CDISC, SDTM, ICH E6(R3), FDA

📧

learn@cliniassure.com

📧

clinibuddy@cliniassure.com

📞

+91 94304 47266

🌐

cliniassure.com

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Premium industry-aligned training · ICH-GCP R3 driven

Live sessions + LMS + CLINI-BUDDY mentorship + Placement

AdvanceDiploma Programs

Advance
Diploma Programs