ClinInfo S.A. (CLIN)
99 rue de Gerland - entrée 7
69007 Lyon
France
www.clininfo.eu
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Mr. Patrick Chevarier CEO, eCRF, Data management Phone: +33 478 614 426 Fax: +33 478 583 167  Contact |
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Mrs. Corinne Chevarier Boutinet
Management Assistant Phone: +33 4 78 61 44 20 Fax: +33 4 78 58 31 67 Contact
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Mr. Vincent Pelletier
Programer Analyst Phone: +33 4 78 61 44 21 Fax: +33 4 78 58 31 67 Contact
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Mr. Thomas Chatenet
Programer Analyst Phone: +33 4 78 61 44 20 Fax: +33 4 78 58 31 67 Contact
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Mr. Khalid El Mechti
Data Manager - Person in charge of Quality Assurance Phone: +33 4 78 61 44 24 Fax: +33 4 78 58 31 67 Contact
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Clininfo SA is a French company specializing in the data 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 or epidemiological studies 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.s (Clinical Research Organization). This rigour has ensured reliable data management for the past 20 years for some of the largest controlled studies ever done. 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
Our multilingual electronic case report form (eCRF) is built on more than two decades of experience with databases dedicated to clinical trials and epidemiology. 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, the recruitment rate, and usual reports 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.
Automated alert can be set up, for example on adverse event detection.
Our helpdesk is available each working day, in English or French.
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