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4Clinics Presentation Vaccine & Immunology CRO 2016

An exclusive business pitch 4Clinics
by

Mehdi Chelbi

on 17 November 2016

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Transcript of 4Clinics Presentation Vaccine & Immunology CRO 2016

4Clinics
Your Vaccine & Immunology CRO

FACTS
NEEDS
Pharmaceutical companies
Experienced and trained specialized resources
Expertise in biometry, writing and regulatory
Cross functional teams with experience in immunology
Biotechnology companies
Full operational support
Expertise in analysis of immunological clinical endpoints
PROBLEMS
How to choose immunological endpoints ?

How to collect and analyse immunological endpoints ?

How to interpret and publish associated results ?
EXPERTISE & SOLUTIONS
Clinical Development
Oncology
Vaccines
Cell Therapy
Immunology
Cardio-Vascular
BIOSTATISTICS
including CDISC / SDTM & ADaM services
DATA MANAGEMENT
Full Services from CRF Design to DB Lock
Project Management
CRF / eCRF Design
Data management plan / Data validation plan
Database design and set-up
Data Entry / Tracking /Cleaning
Check Programming
Data transfert / Data archiving
SAE Reconciliation
Medical term coding
Data Mapping ODM/Study Pooling

Project Management & Coordination
Statistical Analysis Plan - Writing & Review
Data Analysis Programming
Data Analysis
Blind Review Preparation & Follow-up
Analysis for ISS & ISE
Statistical Report
Anonymization
Statistical Section of the Protocol - Writing & Review
Sample Size & Statistical Power Calculation
Independant statistical center for IDMC & DSMB meetings




MEDICAL WRITING
Regulatory Affairs & Scientific Communication
Protocol development
Informed consent
Investigator brochures
Clinical reports
Narratives

Submission dossiers
CTD Format sections 2.2, 2.3, 2.5 and 2.7
US Format dossiers : ISS, ISE, ISBR
Clinical expert statements / Query management

Journal manuscripts
Literature reviews
Scientific brochures
Marketing support
Medical information support
PHARMACOVIGILANCE
including Clinical Safety
Initial review
Safety case tracking
Processing of cases in safety database
Management of adverse events
Coding of medical terms

CIOMS generation
DSUR & PSUR preparation
Narratives writing
Identification of cases reported in literature

Increase in vaccine clinical studies : 2 fold in 20 years

Increase in immunotherapies in clinical stages : 2 fold in 20 years

New therapies are based in immunological endpoints


NEXT
Development Strategy
in the US

US Office in 2017

Partners
Clinical Monitoring
Investigation centers
CROs

Tailored services for Biotech speciliazed in
Vaccines
Immuno-oncology
Cell Therapies

Remote platfoms for Pharma companies developping Vaccines

CLINICAL OPERATIONS
Study management / Staffing solutions
Clinical Project Management
Project Plan
Contract management / Investigator payments
Site selection and feasibility
Monitoring activities
EC & CA Submission
Training
Archiving
FSP Platform
Medical Writing
Biostatistics
Clinical Documentation
Data Management
Outsourcing
Full transcript