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4Clinics Presentation Vaccine & Immunology CRO 2016
Transcript of 4Clinics Presentation Vaccine & Immunology CRO 2016
Your Vaccine & Immunology CRO
Experienced and trained specialized resources
Expertise in biometry, writing and regulatory
Cross functional teams with experience in immunology
Full operational support
Expertise in analysis of immunological clinical endpoints
How to choose immunological endpoints ?
How to collect and analyse immunological endpoints ?
How to interpret and publish associated results ?
EXPERTISE & SOLUTIONS
including CDISC / SDTM & ADaM services
Full Services from CRF Design to DB Lock
CRF / eCRF Design
Data management plan / Data validation plan
Database design and set-up
Data Entry / Tracking /Cleaning
Data transfert / Data archiving
Medical term coding
Data Mapping ODM/Study Pooling
Project Management & Coordination
Statistical Analysis Plan - Writing & Review
Data Analysis Programming
Blind Review Preparation & Follow-up
Analysis for ISS & ISE
Statistical Section of the Protocol - Writing & Review
Sample Size & Statistical Power Calculation
Independant statistical center for IDMC & DSMB meetings
Regulatory Affairs & Scientific Communication
CTD Format sections 2.2, 2.3, 2.5 and 2.7
US Format dossiers : ISS, ISE, ISBR
Clinical expert statements / Query management
Medical information support
including Clinical Safety
Safety case tracking
Processing of cases in safety database
Management of adverse events
Coding of medical terms
DSUR & PSUR preparation
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
in the US
US Office in 2017
Tailored services for Biotech speciliazed in
Remote platfoms for Pharma companies developping Vaccines
Study management / Staffing solutions
Clinical Project Management
Contract management / Investigator payments
Site selection and feasibility
EC & CA Submission