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Laurent GIBEL

Laurent GIBEL

Head of Biometrics

Double training in Applied Mathematics and Computer Science at the University of Toulouse and Pau (France).
Experience in pharmaceutical laboratories (Rhône-Poulenc RORER, Pierre Fabre Médicament, AB Sciences), in IT services company (Altran Technologies), in university hospital (CHU de Limoges), and in association (GORTEC, cooperative group in oncology).
Associate professor at the Master of Physiological and Computer Engineering in Poitiers for 4 years.

Knowledge of SAS programming language (since 1993).

DATA MANAGEMENT - STATISTIQUES: À propos
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Services and Expertise

Your success : our challenge

DATA MANAGEMENT - STATISTIQUES: Services

Within Medical Initiatives, our expertise in Biostatistics and Data Management, from the design of a study project to the clinical study report  :

Methodology

  • Literature review, sample size calculation, statistical design

  • Writing of statistical and data management sections of the protocol

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eCRF development

  • Support for writing eCRF template

  • Design of the e-CRF on our Data Management software

  • Management of user profiles, sites and user's access for users (Investigators, CRAs, PMs...)

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Data Management

  • Programming of consistency checks, management of queries (automatic or manual), data validation listings

  • Management of the documentation according to GCP and Good Clinical Data Management Practices : annotated CRF, data entry guide, data management plan, database structure, data validation plan, data management report…

  • Data Review implementation, management of deviations and analysis populations

  • Import of external data (Lab data...), writing of data transfert specifications

  • Preparation of export tables

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Statistical analysis and reporting

  • Writing of statistical analysis plan

  • Manuscripts and posters writing support

  • Statistical analysis using SAS and R

  • Statistical analysis report writing

  • Preparation and participation in IDMC (Independent Data Monitoring Committee)

Our Quality System is based in Biometrics around twenty Standardized Procedures, Forms and Operating Procedures, under constant review.

MEDICAL INITIATIVES is in the process of ISO certification

Regarding the application of the GDPR * regulation to Biometrics, we ensure compliance with CNIL regulations and in particular the deletion of identifying or indirectly identifying data, limiting the collection of data to those strictly necessary.

* General Data Protection Regulation

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