ClinInfo S.A., Lyon

ClinInfo S.A. (CLIN)

ClinInfo S.A. (CLIN)

99 Rue de Gerland- entre 7
69007 Lyon
France

www.clininfo.eu

 

Team Leader

Patrick Chevarier
Patrick Chevarier

Patrick Chevarier
Chief Executive Officer
Phone: +33 478 614 426
Fax: +33 478 583 167
Contact

Project Members

Vincent Pelletier
Vincent Pelletier

Vincent Pelletier
Programmer, Analyst
Phone:+33 4 78614421
Fax: +33 478583167
Contact

Thomas Chatenet
Thomas Chatenet

Thomas Chatenet
Programmer, Analyst
Phone:+33 4 78614420
Fax: +33 478583167
Contact

Khalid El Mechti
Khalid El Mechti

Khalid El Mechti
Data Manager Person in charge of Quality Assurance
Phone: +33 4 78614424
Fax: +33 478583167
Contact

Institute Presentation

ClinInfo S.A. is a French company specialized in the management of clinical studies data. It was created in 1998, originally as technical support to the Clinical Pharmacology Service at University Claude Bernard-Lyon 1 (Professor Boissel), the first in France to conduct large-scale, multi-centre clinical studies. Our expertise ranges from technical management of large-scale, multi-centre, controlled clinical trials to the development of software applications for the medical field.

We apply a rigorous approach and proven methodologies (including GAMP5) developed from our university clinical origins and through our partnership with C.R.O.s (Clinical Research Organization). Our scalable system can be adapted to any study, small or large, and put into place quickly to manage data from several dozen to tens of thousands of patients. This adaptability and flexibility are reflected in our products as well as in the proven skills of our team.

Background and facilities:

The robustness of the concepts of our multilingual electronic case report form (eCRF) were validated by more than 200 studies, clinical trials, epidemiology studies, pharmacoeconomic studies, and pharmacovigilances studies. The (non limitavive) field of operation are Paediatrics, cardiology, oncology, pneumology, neurology,medical devices. Users are either specialists or general practitioner, in hospital or not. The integrated procedures in production, development, test and maintenance were thoroughly audited and fully documented in compliance with CFR 21, Part 11.

Checks for occurrence, probability, and coherence are made simultaneously with data entry for complex controls. The investigator is warned of any errors detected and can take action immediately. In addition, the coordination centre can follow the quality of the data input in real time.

Data monitoring follows the same process. On-site audit of forms can be done on line. Each clarification is made by clicking on the item, which generates a query that the investigator respond electronically.

For paper based studies we has develloped a double data-entry software and a data entry team dedicaced to medical forms.

Forms can then be controlled using our Data management software. Ths softwar allow easy writing of consistency check ( missing value, range controls inter item controls).

A bridge between our software and SAS ensure the quality of transfer for statistical analysis.