Parcours MODM – Coord Essais Cliniques-english

Parcours MODM – Coord Essais Cliniques-english2017-01-17T16:38:05+00:00

CLINICAL OPERATION MANAGEMENT AND DATA MANAGEMENT – Speciality CLINICAL TRIALS MONITORING

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renseignements : Patrice Ravel

FROM KNOWLEDGE TO PERFORMANCE
TOWARD THE HEALTH AND ENVIRONNEMENT PROFESSIONS

A training course combining clinical trials methodology to project management

TO ACQUIRE KNOWLEDGE
  • Clinical trials monitoring and logistics, good clinical practices,
  • Clinical development: methodology, experimental planning, protocol,
  • International regulations, submission procedures and registration, drug monitoring,
  • Pharmacovigilance,
  • Clinical trials management, operational planning, deadlines management, resources and budget management, subcontractors’ management.
clin1 main
TO ACQUIRE SKILLS
  • Double competence: Clinical research and project management,
  • Mastering the tools necessary to clinical trials management and to clinical studies,
  • Mastering the project management tools: operational planning and resources management,
  • Communication, relational techniques and team work,
  • English.

CLINICAL RESEARCH WORK EXPERIENCE

1 + 5 MONTH WORK PLACEMENT IN MASTER 1 • APPRENTICESHIP IN MASTER 2

EMPLOYMENT OPPORTUNITIES
Clinical research associate manager – Clinical studies coordinator – Clinical studies manager– Clinical project manager

REGULARLY UPDATED CLINICAL RESEARCH AND DATA MANAGEMENT SITES:

scdm

Society for Clinical Data Management

ASDMB

Association Française de Data Management Biomédical

cercle

Cercle Languedoc-Roussillon


Interview of two students

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CLINICAL OPERATION MANAGEMENT AND DATA MANAGEMENT
CLINICAL TRIALS MONITORING

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SKILLS ASSESSMENT GUIDELINES :

GOALS, CONTENTS AND TEACHERS FOR ALL TEACHING UNITS IN THIS COURSE :

MASTER 1 – prog 2015-2016

SEMESTER 1

COMMON CORE(S1)

TU 101 : REGULATORY AND FINANCIAL ASPECTS – QUALITY AND SAFETY

Goals:

Pharmaceutical law:

  • To know the various texts applying to the field of medicines, their origin, their legal value, their articulation
  • To have some knowledge of the various health products
  • To know the basics of innovation protection control, manufacturing, marketing and monitoring of medicines

Quality :

  • To know the quality demands and management tools

Security :

  • To know the regulations of ICPE classified installations
  • To know the classification and labelling of chemical products’ hazards

Marketing :

  • To integrate the marketing’s global approach
  • To know the diagnostic tools and the strategic directions

Financial analysis

  • To be able to analyse the profitability, the solvency and the liquidity of an economic activity (industrial company)

Content:

  • Pharmaceutical law (18hrs-Lecture)
  • Financial analysis (12hrs-Lecture)
  • Marketing (6hrs-Lecture)
  • Quality (10hrs-Lecture)
  • Safety (6hrs-Lecture)

Teachers:

  • V. RAGE-ANDRIEU
  • C. LE GAL
  • R. BARTHES
  • N. DELELIGNE
  • A. ESCANDE
  • V. BOISSERIE LAPORTE
  • O. VEYRET
  • A. GARD

TU 102: DATABASES – EPIDEMIOLOGY AND ENVIRONNEMENTAL HEALTH

Goals:

To comprehend epidemiological studies:

  • To identify epidemiology as public health tools
  • To know the epidemiological surveillance tools
  • To know the different types of epidemiological surveys
  • To be able to interpret descriptive epidemiology indicators
  • To be able to calculate and interpret the results of risk calculation (RR and OR) from analytical epidemiology
  • To be able to describe and criticise the strategies and protocols of studies implemented in epidemiology
  • To be able to assess the validity of screening tests
  • To know the behaviour and the impact of organic pollutants present in the environnement and to understand the related legislation

Databases:

  • To discover the basics of databases management
  • To understand how the information is structured thanks to the relational model
  • To recognise the different database usage patterns (administrator/client)
  • To be able to build a database including a few tables
  • To be able to define the main confines on a database
  • To be abe to use the main commands of the SQL language
  • To be autonomous on the data management system ACCESS (Microsoft)

Content:

  • Database (4hrs-Lecture+ 15hrs-Tutorial)
  • Epidemiology (12hrs-Lecture)
  • Environmental health (18hrs-Lecture)

Teachers:

  • M. VIVIEN
  • P. RAVEL
  • H. FENET
  • A. ESCANDE
  • F. COURANT
  • C. CASELLAS
  • E. GOMEZ

TU 103: HEALTH PRODUCTS DEVELOPMENT STRATEGY– PROJECT MANAGEMENT AND CLINICAL DEVELOPMENT

Goals:

  • General knowledge of the sectors of medicines, cosmetology and medical devices
  • Knowledge of the regulatory and socio-economic specificities of the medicines, cosmetology and medical devices
  • Initiation to the project management of health products development
  • Initiation to the proceedings of clinical trials in accordance with the Good Clinical Practices (GCP)

Content:

  • Development strategy: Medicines (12hrs-Lecture), Cosmetology (6hrs-Lecture) and Medical Devices (6hrs-Lectures)
  • Regulations in Europe, Japan and the United-States (6hrs-Lecture)
  • Clinical development (9hrs-Lecture)
  • Project management (6hrs-Lecture + 3hrs-Tutorial)

Teachers:

Montpellier University

  • B. BATAILLE
  • S. BEGU
  • J. COUDANE
  • X. GARRIC
  • A. EL GHAZOUI
  • P. CREMADES
  • W. AGOUMI

TU 104: BIOTECHNOLOGIES APPLIED TO HEALTH

Goals:

  • To know the various health products produced by biotechnologies
  • To acquire the notions of therapeutic targets and biomarkers
  • To acquire the notions of medium and high throughput screening
  • To know the technologies of recombinant DNA (GMO notion) and protein engineering
  • To know the production and quality control processes
  • To have a concrete overview of the conditions of production of a recombinant protein and of the development of a cellular model that is compatible with medium throughput screening (practical works carried out)

Content:

  • Identification of the molecular or cellular targets and of the biomarkers (8hrs-Lecture)
  • Production/Quality control (3hrs-Lecture)
  • Industrial applications/examples (11hrs-Lecture)
  • Virtual cloning (6hrs-Tutorial)
  • Production, purification, characterisation of a recombinant protein (12hrs-Practical work)
  • Preparation of a cellular model for medium throughput screening– visit of a high throughput pharmacological screening platform (10hrs-Practical work)

Teachers:

Montpellier University

  • S. CHAUMONT
  • A. CHOQUET
  • F. COURANT
  • S. DELBECQ
  • A-D. LAJOIX
  • X. GARRIC
  • S. MARY
  • F. MACARI-FINE
  • M.A. POUL

External professionals

  • ARPEGE Platform, IGF Montpellier

TU 105: FOREIGN LANGUAGES AND COMMUNICATION

Goals:

  • To develop communication skills in foreign languages
  • Specialized vocabulary
  • Knowledge of the companies and health matters in the countries of the target language
  • Cultural approach

Content:

  • Foreign languages (40hrs-Tutorial)
  • Communication (9hrs-Tutorial)

Teachers:

Montpellier University

  • I. MAITRE-DEVALLON
  • Y. ZAMBRANO
  • G. NICKSON
  • P. WEINMANN

Teachers extérieurs

  • Communication consultancy

SPECIFIC TU: CLINICAL OPERATION MANAGEMENT AND DATA MANAGEMENT (S1)

TU 107: THERAPEUTIC APPROACHES – PHARMACOKINETIC – PEC

Goals:

  • To acquire the basic knowledge related to the different therapeutic approaches which are subject to clinical studies (clinical research professions)
  • To understand the pharmacokinetic file
  • To be able to introduce oneself orally and in writing

Content:

Therapeutic approaches

  • Cancerology, Cardiovascular disorders, SNC, Pneumology, Thrombosis, Diabetes, High blood pressure, Haematology, Rheumatology, Psychiatry, Analgesics, Malaria, Infectiology, Vaccine trials, Medical devices trials

Pharmacokinetics

  • Definition of the main variables included in Phase 1 of the clinical development’s proceedings

Teachers:

Montpellier University

  • B. BAÑULS
  • S. KHIER
  • G. CROS
  • P. DRAKULOVSKI
  • S. HANSEL
  • M. MAILLIE

External professionals

  • Médecins hospitaliers et cliniques
  • Professional speakers

SEMESTER 2

COMMON CORE(S2)

TU 201: ENGLISH AND SECOND LANGUAGE

Goals:

  • To develop communication skills in a foreign language
  • Specialised vocabulary
  • Knowledge of the companies and health matters in the countries of the target language
  • Cultural approach

Content: 40hrs

  • Work on all communication skills: written and oral expression and comprehension
  • Knowledge of the professional and cultural international environment
  • Job interview simulation, oral presentation using PowerPoint, meetings simulation, writing letters and emails, debates, documents reading etc.
  • Methodological aspects (according to the groups’ needs)
  • Practice on digital platform aiming at revising and strengthening language skills

Teachers:

  • I. MAITRE-DEVALLON
  • Y. ZAMBRANO
  • G. NICKSON
  • P. WEINMANN

TU 202: 3 to 5 MONTH WORK PLACEMENT

Goals:

  • To put into practice the skills gained during the training course
  • To achieve a concrete professional project within one’s context of activities

Content:

  • Preparation and instruction to find and complete a work placement (3hrs-Lecture)
  • 3 to 5 months full-time in a public or private company

Teachers:

  • B. BAÑULS
  • B. BATAILLE
  • S. BEGU
  • A. EL GHZAOUI
  • P. RAVEL
  • M. VIVIEN
  • A. ESCANDE
  • E. GOMEZ
  • B. NOTTELET
  • X. GARRIC

SPECIFIC TU: CLINICAL OPERATION MANAGEMENT AND DATA MANAGEMENT (S2)

TU 209 : CLINICAL TRIALS MONITORING AND LOGISTICS

Goals:

  • To acquire the basic knowledge related to clinical trials implementation (profession of Clinical research associate)
  • Good Clinical Practices
  • The profession of Clinical research associate (CRA)

Content:

Clinical trials Monitoring and Logistics:

  • Trial implementation, protocol, case report forms, e-FIU
  • Monitoring visits follow-up from the first visit to the closing
  • Investigators: recruitment and training, brochures
  • Essential documents for conducting trials (before, during and end of trial)
  • Documents for submission to HAS (ANSM, CPP, CNIL…)
  • Distribution of clinical batches

Clinical research key players and professions :

  • The profession of laboratory CRA / hospital CRA
  • The structures involved in clinical research (CIC, URC, CRC, CRB..)

Clinical trials in Phase I, II, III

Bioequivalence tests

Epidemiological studies

Preparation to work placements

Hospital work placement (4 weeks)

Teachers:

Montpellier University

  • B. BAÑULS
  • V. BOISSERIE LAPORTE (PAST)

External professionals

  • Pharmaceutical industry professionals, of CRO and UHC

TU 210: REGULATORY AFFAIRS, PCB, DRUG MONITORING

Goals:

  • To acquire the basic knowledge in the regulatory environment (profession of Clinical Research and Development)
  • To master the Good Clinical Practices – standardisation ICH, CTD, FDA, EMEA, AFFSAPS, …
  • Drug monitoring, adverse effects

Content:

  • Quality assurance and quality control in clinical research and audits
  • Regulatory environment Europe, US, Japan
  • Protocol implementation
  • Good Clinical Practices – standardisation ICH, CTD, FDA, EMEA, AFFSAPS …
  • Drug monitoring, adverse effects

Teachers:

Montpellier University

  • V. BOISSERIE LAPORTE (PAST)

External professionals

  • Pharmaceutical industry professionals, of CRO and UHC

TU 211: INTRODUCTION TO CLINICAL DATABASES MANAGEMENT – DATA MANAGEMENT

Goals:

  • Introduction to DATA management
  • To know the different clinical data entry methods
  • To give the students who wish to pursue a career in the CRA professions the basic knowledge related to clinical databases management: to be able to create a database from a FIU, to know the main controls
  • To understand the main statistical analysis associated to clinical trials

Content:

DATA Management:

  • The profession of data manager
  • The context of data management

Introduction to the SAS language:

  • Creating tables
  • Importing data files
  • Using simple procedures for the description of statistical data
  • Using some statistical procedures

Statistical methodology applied to clinical research:

  • Stastistics reminder
  • Experimental plans: parallel plans, matched series plans, ‘cross over’ plans, Bioequivalence tests

Medical writing

Teachers:

Montpellier University

  • P. Ravel
  • M. Vivien
  • R. Sabatier

External professionals

  • Effi-Stat and ESISMP school
MASTER 2 – prog 2016-2017

SEMESTER 3

COMMON CORE(S3)

TU 301: HEALTH PRODUCTS PROJECT MANAGEMENT, MANAGEMENT CONTROL AND PERFORMANCE MANAGEMENT

Goals:

Project management:

  • To understand the concepts, processes and project management methods within the frame described by the Project Management Institute
  • Operational planning: from analysing a project to the preparation of a feasible work schedule
  • To know the basic framework of innovation protection, manufacturing, the marketing and surveillance of medicines

Management control:

  • To assess and understand through an account of company’s results, the items of profitality and performance

MS Project:

  • To be able to use the MS Project software

Content:

  • Project management (12hrs- Lecture + 12hrs-Tutorial)
  • Management control and performance management (6hrs-Lecture + 6hrs-Tutorial)
  • MS Project software (12hrs-Tutorial)

Teachers:

Montpellier University

  • P. CREMADES
  • R. BARTHES

External professionals

  • Service provider

TU 302: QUALITY MANAGEMENT, MARKETING

Goals:

Team management:

  • To clarify the missions, roles and function of a team manager (project)
  • To understand the influence of one’s leadership of the team’s performance
  • To identify one’s management style, one’s negotiation style
  • To be able to lead a meeting

Quality management :

  • To master quality management

Marketing:

  • To understand the market’s mechanisms
  • To be able to identify the relevant stakeholders and to analyse the influence factors
  • To know the various strategic manoeuvres (by comparison with the demand and faced with the competition)
  • To be able to define the appropriate operational modes

Content:

  • Team management (12,5hrs-Tutorial)
  • Quality management (14hrs-Lecture + 12hrs-Tutorial)
  • Marketing (12hrs-Lecture)

Teachers:

  • R. BARTHES
  • N. DE LELIGNE
  • L. KABBARA BARDINA

SPECIFIC TU : CLINICAL OPERATION MANAGEMENT AND DATA MANAGEMENT – Speciality CLINICAL TRIALS MONITORING (S3)

TU 303: HEALTH PRODUCTS PROJECT MANAGEMENT

Goals:

  • To understand, through concrete industrial projets examples, the project management concepts related to the control and management of deadlines, resources, risks and the budget

Content:

  • The projects, why and how
  • Company projects’ localisation and typology
  • Organising the projects – the conception approaches
  • Resources and risks management
  • Deadlines and costs control

Teachers:

Montpellier University

  • P. CREMADES

External professionals

  • Pierre Fabre
  • Sanofi
  • GSK
  • Bayer

TU 311 : DATA MANAGEMENT 1

Goals:

  • To know the basics of CDISC and STDM standards
  • To know the regulations regarding patients’ data
  • To be able to design a plan for the validation of a clinical study
  • To be able to carry out the « data cleaning » stages
  • To know the basics of risks management
  • To know and understand the issues encountered during the coding of the undesirable events and concomiting treatements, and the coding dictionary

Content:

  • CDISC – SDTM
  • Data Privacy
  • Validation plan
  • Data Cleaning
  • Risks management
  • Coding undesirable events and concomitant treatments

Teachers:

  • External professionals: QuanticSoft, Effi-Stat, Laboratory of International Research Servier, Sanofi, MedDRa correspondant

TU 312 : CLINICAL OPERATIONS MANAGEMENT

Goals:

  • To coordinate and supervise international clinical studies in accordance with regulations and deadlines
  • To define the human resources and financial needs for the clinical development projects
  • To lead and coordinate the international teams undertaking the monitoring in accordance with regulations and deadlines

Content:

  • Implementation of a clinical study in accordance with regulations and deadlines (Project management plan, monitoring plan, SAE flow plan….)
  • Feasability study, organisation and participation to investigators’ meetings, preparation of MEP, monitoring and closing visits…
  • Constitution of applications to be submitted to the relevant authorities
  • Provisional budget of a clinical study, subcontractors’ management
  • Medical writing
  • Operational planning of clinical trials
  • Risks management in clinical trials

Teachers:

Montpellier University

  • V. BOISSERIE LAPORTE (Past)

External professionals

  • Pharmaceutical industry professionals, of CRO and UHC, Sanofi, ESISMP

TU 313: REGULATORY AFFAIRS – DRUG MONITORING, MARKETING

Goals:

  • To coordinate and supervise the international clinical studies in accordance with the regulations and deadlines
  • Marketing and post marketing in clinical trials
  • Drug monitoring management
  • Supply chain management

Content:

  • International regulations
  • The essential documents (ICH 6)
  • Management of files submitted to HAS, ICH 8 documents
  • Quality assurance, audit
  • Marketing surveys
  • Post marketing surveys
  • Drug monitoring – SAE Data reconciliation
  • The generics – bioequivalence
  • IP circuit, Clinical Supply Chain
  • Interculturalism
  • Pharmacoeconomy, Competitive Intelligence

Teachers:

Montpellier University

  • P. RAVEL (MCU)
  • V. BOISSERIE LAPORTE (Past)

External professionals

  • Pharmaceutical industry professionals, of CRO and UHC

TU 314: LEARNING BY PROJECT

Goals :

  • Practice on Master 2 teaching contents through case studies supervised by pharmaceutical industry professionals

Content:

  • Launch of a new health or cosmetic product
  • Business plan, budget and resources management
  • Managing a clinical study’s subcontractors

Teaching methods :

  • Work in a group of 4 to 6 students according to the projects. At the end of his course, the professional presents the problem to be dealt with by the group of students. Within each group, the students share the work to be carried out. The project monitoring takes place regularly based on a previously established calendar.

SEMESTER 4

COMMON CORE- STAGE (S4)

TU 401: 4 TO 6 MONTH WORK PLACEMENT

Goals:

  • To carry out a concrete professional project within its context of activities

Content:

  • 2hrs Lecture: preparation and instructions to find and do a work placement
  • 4 to 6 months full-time in a public or private company

Teachers:

  • B. BAÑULS
  • B. BATAILLE
  • S. BEGU
  • A. EL GHZAOUI
  • P. RAVEL
  • M. VIVIEN
  • E. GOMEZ
  • X. GARRIC

SPECIFIC TU: CLINICAL OPERATION MANAGEMENT AND DATA MANAGEMENT(S4)

TU 406: ANALYSIS AND CLINICAL DATA MANAGEMENT TOOLS

Goals:

  • Introduction to VBA programming on spreadsheets
  • To understand and interpret a statistics analysis plan in clinical trials (ICH)

Content:

The VBA language:

  • The concept of algorithms
  • The macros
  • VBA’s main instructions: variable, typing, conditional structures, loop structures, procedures and functions
  • Examples on clinical research specific dashboards

The PAS:

  • Concept of risks, the main plans, main and secondary variables, number of topics and and type of population to include
  • The main types of trials in statistics
  • Quality of life and survival
  • ICH9

Teachers:

Montpellier University

  • P. RAVEL

External professionals

  • Pharmaceutical industry professionals, of CRO and UHC
  • Sanofi
  • Val d’Aurelle

TU 407: SPECIFIC CLINICAL TRIALS

Goals:

  • To know the specific clinical trials and their peculiarities compared with “classical” trials

Content:

  • Vaccine clinical trials
  • Clinical trials and medical devices
  • Clinical trials and rare diseases
  • Clinical trials on diagnostics
  • Clinical trials in cosmetic products
  • Clinical trials and contrast agents
  • Paediatric investigation plan
  • Quality of life in clinical trials

Teachers:

Montpellier University

  • V. BOISSERIE LAOPRTE (PAST)

External professionals

  • Pharmaceutical industry professionals, of CRO and UHC

TU 408: CASE STUDY

Goals:

  • Practice on the teaching contents of Marster 2 through case studies supervised by professionals of clinical research

Content:

  • Clinical study of a new medical device, submission of a clinical study to the health authorities, operational management of a clinicial study…

télécharger la fiche et la liste (2015-2016) des UE du parcours

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