Our teams are on hand to guide you on your projects. Our experts give you advice on which technology to choose and the best methodology to apply for collecting and leveraging your data, guaranteeing you excellent quality.

Our strengths:

Our team’s experience, the advice provided and the availability of key contactsclin

Solutions for each type of research issue (epidemiological, ATU, phase 1, etc.)

– Real expertise in data migration and/or transfer

Tried and tested software that is FDA 21 CFR part 11 compliant (electronic signature, audit trail, etc.)

– A system validated via a dedicated protocol: IQ/OQ/PQ/FDAQ

– A powerful system with virtual servers, a secure server room and external backups

Ennov Clinical Expert since 2005

Data Management

– Writing and following up of documentation: Data Management Plan and its appendices
Database set-up using Ennov Clinical’s CDMS
– A data entry platform and trained entry operators
Double comparative and independent data entry or single data entry
– Guaranteed error rate < 1/1000
Edit check programming and query management
– Coding of medical data using MedDRA & WHO-drug standards
SAS programming for patient listing and profile generation
Reconciliation between clinical and PV databases
Data review management (blind review) and database locking
External data imports (biological results, compliance, medical device, etc.)
Data exports (SAS, XML, TXT, etc. formats)
Secure clinical data transfers (sFTP)
SDTM mapping (CDISC)

eCRF

– Writing up of specifications
100 % FDA 21 CFR part 11 certified
Secure hosting
– Development on client servers with remote access See portal
– Dedicated and customised access portal (logo, graphic standard)
– Integrated Webmail
Study documentation loading
Online edit check system
Online manual creation of queries by CRAs
– Setting up of an independent medical validation workflow (adjudication)
Page display management with profile-based access (access rights)
– Possibility of adding attachments to patient folders
– Generation of CRFs in PDF format
– Implementation of an automatic alert and vigilance flow
Medical electronic signature
– ‘Cradle to grave’ audit trail
– Encryption of data sent via the internet (SSL up to 128 bits)
– Clinical studies combining both paper CRFs and eCRFs

Randomisation

– Setting up of an IVR system
– Web randomisation – IWRS
– Stratified randomisation with a minimisation algorithm
eCRF-integrated system
24 hour a day access
Dedicated hotline

Customised developments

Dynamic dashboards accessed via a project-specific website (downloads, graphic standards, profile-managed access rights, dynamic maps)
– Retrieval of your data via an FTP-secured data exchange system and data exploitation on websites available 24/7
– Creation and monitoring of photograph libraries
Vigilance flows: e-mail and text message alerts
– Design of e-learning sites
– Development of dedicated applications using different technologies
ePRO on tablets, smartphones (Patient Recovery Outcome)
ATU/RTU web portal, autonomous account creation, data entry and automatic vigilance flows to authorities

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Statistical methodology

– Calculation of the number of subjects required
– Writing of the protocol’s statistics paragraph
Randomisation list and plan
– Writing of the statistical analysis plan with a list of TFLs
Mock table preparation

 SAS programming

Certified SAS programmers
Validation via double programming
– Individual data listing and Clinical Study Report appendice

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Analytical and exploratory statistics

Descriptive statistics
Efficacy, tolerance and survival analysis
Linear, logistic and multifactorial regressions
– Write-up of statistical reports with a summary
Presentation of results

EURAXI

Euraxi is a project management specialist in clinical research and epidemiology, assisting clients with their projects since 1986. Our organisation and service offer have been perfectly tailored to meet the precise needs of our clients. We can take on all or part of your operations thanks to our multidisciplinary team. This team is organised into specialised units and is guided by quality procedures inherent to the requirements of your projects.

CONTACT

10 Rue Gutenberg
37300 Joué-lès-Tours
France

Tel: +33 2 47 74 32 00

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