Arnoult.org

Our consultants will help you to reach the optimal use of new IT technologies in the process of collecting critical and sensitive data (electronic data capture "EDC"):

E-CRF, Patient Diary Lab e-book, LIMS Electronic Signature Data Management & Data Coding (MedDRA) Audit Trail Sensitive Data Hosting (security) Storage and long term Archiving of digital data Systems Validation according to regulations, guidances, guidelines and standards: GxP, ICH FDA (21 CFR part 11), UE (Annex 11), CNIL GAMP PIC/S CDISC, HL7 Quality Assurance