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 assessement ,

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

• the preparation and submission of regulatory documents for authorization: Ethic Committee, Compétente 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 Biostastistics

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 analyzes.

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