Partner 8 - Clininfo S.A.
Clininfo SA is a French company specializing 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 developed from our university clinical origins and through our partnership with the C.R.O (Clinical Research Organization). This has ensured reliable data management for the past 20 years for some of the largest studies ever done (n=50000). Our scalable system can be adapted to small or large study, 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. ClinInfo has computerized 800 studies including 280 eCRF including 150 RCT.
Background and facilities
Our multilingual electronic case report form (eCRF) is built on more than two decades of experience with databases dedicated to clinical trials. The robustness of the concepts and the data structures we use were validated by several dozen studies, following phase IV tests in oncology (both hospital and specialist). 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, or as quickly as possible after, 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. Management monitoring follows the same process. On-site audit of forms can be done on line. Each modification is made by clicking on the item, which generates a change that the investigator validates electronically.
ClinInfo has strong skills in providing eCRF for pan European projects Like CFMATTERS, ClinInfo was successfully involved in 5 FP7 projects as partner or service provider. After a first FP7 project 3 years ago ClinInfo has built a strong and productive partnership with UCC who is also involved in CFMATTERS. ClinInfo is currently involved in 2 US project, and will be involved in 5 in 2013. This is an advantage because many investigators of CTMATTERS will be US based.
Patrick Chevarier has 25 years of experience on IT for clinical trials in France and Canada.
Nicolas Monté and Vincent Pelletier have respectively 5 and 10 years of experience in setting up eCRF for internationals studies