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  1. Project management

 

Weprom guarantees that projects are carried out in compliance with " Bonnes Pratiques Cliniques " and the regulations in force with :

  • the implementation of feasibility studies,

  • evaluation of costs and deadlines,

  • drafting study documents:

    • drafting of the protocol,

    • observation book design,

  • the preparation and submission of regulatory documents for authorization : CPP ANSM, CNIL, ...)

  • the selection of investigation centers

  • preparation and participation in investigator meetings,

  • the setting up of visits to the investigation centers and individualized training for the actors of the study,

  • monitoring management,

  • the closure of centers at the end of the study,

  • management of other stakeholders or partners.

 

     2. Biometrics

      _cc781905- 5cde-3194-bb3b-136bad5cf58d_     2.1. data management

 

Data management is supported by ENNOV Clinical® software.   This tool allows complete data management of a study from the development of the database and the CRF to the production of a validated database for quality statistical analysis with :

  • development of the database,

  • data validation,

  • medical data coding,

  • quality control and end-of-study management.

 

This tool includes an audit trail ensuring optimal traceability of all actions carried out on the database. 

 

            2.2. Methodology and Biostatistics

 

Weprom, thanks to the experience of these collaborators, is able to manage :

  • methodological aspects (design of the research, calculation of the number of subjects required, drafting of the statistical part of the protocol),

  • randomization : Weprom manages the process of randomization (stratification, etc.) and product allocation and uses the same tool as for data management  ENNOV Clinical®,

  • statistical analyses.

 

The programming of the statistical analysis is carried out with SAS® or R®.

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Regulations applied (non-exhaustive list):

  • Law 2012-300 of 05/03/2012 amended by decree 2016-800 of 16/06/2016

  • Good clinical practices of 24/11/2006 (and ICH-E6)

  • EN14155 standard for medical devices

  • GDPR n°2016-679

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