Monitoring

The quality of Monitoring is one of the main elements of data quality of our trials or surveys.

We are aware of your demands and we are able to bring your projects to a very high quality data with a management of studies performed by qualified project leaders and dedicated CRA who are able to meet your expectations.

Expertise

Selection of investigational centers

Initiation visit - [Find out more]

Presentation of study related documents.

Pharmacovigilance (EIG).

Signature of study related documents (Protocol, Study related contracts, financial contracts ...)

Check that all materials/equipments necessary to the conduct of the study are available at each investigational site.

Routine on-site visit - [Find out more]

Review CRF and Queries data versus source documentations.

Review of Adverses Events and Serious Adverse Events.

Site closure visit - [Find out more]

Monitor the last queries answered by the investigator.

Check that all documents are duly signed on Investigator file.

Inform the sites of any potential contact for further request and of archiving the Study documents during 15 years at least.

Collect of all documents including study related accounts.

Our qualified CRAs are involved in all steps of monitoring during the study (CRFs, questionnaires, diaries, queries…) and being support to the investigators throughout the trial. The Project Leader, who is the guarantee of respect of your goal, manages the CRAs team dedicated to your project.