Healthcare Engineering
Bachelor's / Master's Degree in Montpellier

MODM Clinical Trials Coordination

THE PROGRAM PROVIDES DUAL EXPERTISE IN THE FIELDS OF CLINICAL RESEARCH AND PROJECT MANAGEMENT. IT TRAINS EXECUTIVES SPECIALIZING IN CLINICAL RESEARCH: CLINICAL RESEARCH ASSOCIATES, INTERNATIONAL CLINICAL TRIAL COORDINATORS

OBJECTIVES

The goal is to train professionals specializing in the role of Clinical Research Associate (CRA) during the first year of the master’s program. The program is supplemented in the second year with a focus on project management, preparing students for the role of International Clinical Trial Coordinator. The program is delivered through a work-study format at major pharmaceutical companies.

Highlights of the Clinical Trials Coordination Program

– Project-based learning

– Career Placement

– Work-study program

– In-person guest lecturers (40% in the first year of the master’s program, 70% in the second year)

– Student support

SPECIFIC KNOWLEDGE GAINED THROUGH THE PROGRAM

Master's Degree (Year 1)

  • Therapeutic Approaches
  • Clinical Trial Monitoring and Logistics:
    - Regulatory Environment, Preclinical Dossier, Clinical Dossier
  • Essential ICH documents for conducting clinical trials (before, during, and after the trial).
  • Introduction to Clinical Database Management and CDISC Standards.
  • Medical writing in accordance with ICH guidelines

Master's Degree (Year 2)

  • Project management, planning, and coordination in the conduct of international clinical trials
  • Feasibility study, human and financial resource requirements
  • Clinical Data Management, Data Management, Risk-Based Monitoring, and GDPR
  • Statistical Methods Applied to Clinical Trials
  • Pharmacovigilance, Adverse Event Management
  • Subcontractor Management

SPECIFIC SKILLS GAINED THROUGH THIS PROGRAM

  • Mastering Project Management: Planning, Cost Management, Schedule Management, and Risk Management
  • Develop, coordinate, monitor, and conduct clinical trials
  • How to Conduct a Feasibility Study
  • Have a thorough understanding of international regulations (ICH, FDA, CTD, etc.).
  • Be familiar with standard procedures
  • Ensure compliance, quality, and data management
  • Understanding the statistical methodology of clinical trials
  • Managing Adverse Events, Pharmacovigilance
  • Knowing how to write a clinical study report in accordance with ICH guidelines
  • Managing Subcontracting in the Developer-CRO Relationship
  • Adhering to ethical standards in clinical trials

TEACHING SKILLS AND PROFESSIONAL EXPERIENCE

  • 3D Printing Education Hub for Healthcare. Learning Lab, flipped classroom, interactive seminars, company visits, project-based learning…
  • Many external professionals
  • M1 and M2 programs are open to apprentices, with tailored schedules designed to optimize hands-on training

CAREER OPPORTUNITIES

ARC, ARC Manager | Clinical Trial Coordinator | Clinical Trial Manager | Clinical Project Manager

Download the route description for the route

Video: Interview with a student who is both in a 6th-year pharmacy student and an M2 student in Clinical Operations Management as part of INSIDE IS ISMA

ACADEMIC CALENDAR: 2025/2026/2027

All courses in the M1+M2 core curriculum (download)

All specific units of m² (download)

The specific courses for the first year of the Master's program ( ):

SEMESTER 1:

TU : THERAPEUTIC INDICATIONS – PHARMACOKINETICS – MANAGEMENT

Number of ECTS credits = 5 – TU Coordinator TU  Patrice Ravel

Prerequisites:Physiology Course(Bachelor’s Degree), Understanding the clinical trial process

Course details:   43.5 hours of lectures + 6 hours of tutorials

Objectives

    • To provide students pursuing careers in clinical research with a basic understanding of the various therapeutic areas currently being studied in clinical trials
    • Understanding the pharmacokinetic profile
    • Knowing how to present yourself verbally and in writing

CONTENTS of theTU

THERAPEUTIC APPROACHES

Oncology, Cardiovascular, CNS, Pulmonology, Thrombosis, Diabetes, Hypertension, Hematology, Rheumatology, Psychiatry, Analgesics, Malaria, Infectious Diseases, Vaccine Trials, Medical Device Trials

PHARMACOKINETICS

Definition of the key variables involved in the conduct of Phase 1 clinical development

PEC
Oral presentations by English and French students
CV and cover letter review

Teaching methods:
Lectures and tutorials

Assessment method: Written exam

Speakers

Montpellier University and External Professionals

SEMESTER 2

TU : CLINICAL TRIAL MONITORING AND LOGISTICS

Number of ECTS credits = 5 – TU Coordinator TU   Patrice RAVEL

Prerequisite: This TU cannot TU separately from the other TU to this program.

Course details: 41 hours of lectures + 6 hours of tutorials This TU required hours (APP + hospital internship)

Objectives

  • To provide students pursuing careers as Clinical Research Coordinators with the basic knowledge required to set up and monitor clinical trials in accordance with good clinical practice.
  • Define the different phases of clinical trials.
  • Provide an overview of the role of a Clinical Research Associate (CRA) and all of their responsibilities.

Contents

Phase I, II, and III clinical trials

Clinical Trial Monitoring and Logistics

  • Trial setup, protocol, observation log, e-CRF,
  • Tracking of monitoring visits from the first visit through to the final visit.
  • Investigators: recruitment, training, brochures
  • Essential documents for conducting tests (before, during, and after the test)
  • Documents for submission to the HAS (ANSM, CPP, CNIL, etc.)
  • Allocation of clinical groups

Key players and roles in clinical research

  • The Arc Laboratory/Arc Hospital Program
  • Organizations involved in clinical research (CIC, URC, CRC, CRB, etc.),

Bioequivalence Studies

  • Testing of medical devices

Hospital Internship (4 weeks)

Speakers: External professionals

TU : REGULATORY AFFAIRS, GCP, PHARMACOVIGILANCE

Number of ECTS credits = 5 – TU Coordinator TU  Patrice RAVEL

 Prerequisite: This TU cannot TU separately from TU other TU to this program

Terms and Conditions: 32 hours of lectures + 6 hours of lectures + 3 hours of tutorials

Objectives

  • To provide students pursuing careers in clinical research and development with a basic understanding of the regulatory environment.
  • Mastering Good Clinical Practices—ICH, CTD, FDA, EMEA, ANSM, CPP standards …
  • Learn the basics of pharmacovigilance and adverse drug reactions.
  • Provide an overview of the basics of clinical trial planning.

Contents

  • Regulatory environment for clinical trials
  • Good Clinical Practice – ICH, CTD, FDA, EMEA, ANSM, CPP, and other standards
  • Quality Assurance and Quality Control in Clinical Research and Audits
  • Pharmacovigilance, serious and non-serious adverse events
  • Operational Planning

Teaching methods:

  • Lectures, tutorials, and projects supervised by professionals.

Assessment methods:Written exam – Case study

Speakers

University of Montpellier and External Professionals

TU : INTRODUCTION TO CLINICAL DATABASE MANAGEMENT – DATA MANAGEMENT

Number of ECTS credits = 5 – TU Coordinator TU    Patrice RAVEL

Essential prerequisite: 

This TU cannot TU taken separately from TU other TU to the program.

Prerequisites in Statistics: Bachelor's degree in Health Engineering.

Objectives

  • An Introduction to Clinical Database Management
  • Know how to create a database from a CRF and understand the key data quality controls.
  • An Introduction to Data Management and the Key Responsibilities of a Data Manager.
  • Understand the various tools and methods for entering source data.
  • Master the fundamentals of statistical analysis as applied to clinical trials.

Contents

Data Management

  • Definition and Responsibilities of a Data Manager
  • Database structure, data quality control, database freeze

Introduction to SAS

  • Creating tables, importing data files, and using simple procedures for the statistical analysis of clinical data.

Statistical Methods Applied to Clinical Research

  • Statistics Overview
  • Experimental designs: parallel designs, paired-series designs, crossover designs, bioequivalence tests

Epidemiological Studies

Medical Writing

Teaching methods:

  • Lectures, tutorials, lab sessions, and application of course material through a supervised project using ACCESS
  • 5 three-hour practical sessions on SAS software per student

Assessment criteria:

  • Written exam – SAS practical exam and ongoing assessment
  • Supervised project and written report

Speakers

University of Montpellier and External Professionals