Your projects in good hands
Our Contract Research Organization has a dedicated department watching over:
- Strict compliance with regulations (New European regulations, EMA, FDA, ICH, 21 CFR Part 11, GCP)
- Perfect compliance with ethics and confidentiality
- Validation of internal IT tools or in conjunction with software publishers
- Conducting internal audits of all the company’s departments
- The drafting and monitoring of operational procedures for all activities
- Follow-up of staff training.
We are regularly audited by our customers either during qualification audits or during study audits. The conclusion of these audits always shows a high level of quality for all our services and our support functions allowing us to offer our services in clinical development of drugs from phase I to phase III.
Your data secured
In addition, IT security is ensured by hosting and backing up all data and programs developed within the company in two separate and distant French data centers.
Our host is certified as a “Health Data Host”.
Our references
ELSAN
