1.Project Management

WeproM guarantees a realization of the projects in compliance with the "Good Clinical Practices" and the regulations in force with:

• the costs and deadlines assessment,

• the drafting of the study documents: protocol, case report form ...

• the preparation and submission of regulatory documents for authorization: Ethics Committee, Competent Authority, ...

• the selection of investigation centers,

• the management of investigators meetings,

• the setting up of investigation centers  and individual training for the actors of the study,

• the management of quality control at site,

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

• management of other partners.

 

2.Biometry

       2.1 . data management

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

• the development of the database,

• the validation of data,

• the medical coding of data,

• the quality control, database freezing and archiving.

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

 

       2.2 . Methodology and Biostatistics

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

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

• the randomization: Weprom manages the randomization process (method, design, stratification factors ...) and product allocation. For this we use the same tool as for data management ENNOV Clinical®,

• the statistical analyses.

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