Follow-up of VICH recommendations for clinical studies in animal health
The study protocols are set up with the collaboration of veterinary investigators who will administer the product under development to their clients’ animals. The explicit and written consent of the animal’s owner, who will have been informed by the veterinarian about the clinical trial, is essential.
Pre-clinical studies can also be supported.
The Data management department adapts its online applications to the reality of veterinarians who must enter data often at a distance from their practice.
Our medical writers produce pre-clinical and clinical study reports, publications or any other medical document in compliance with the regulations, in particular ICH, in English or French.
They can also prepare numerous clinical regulatory documents from the initiation of the study to the final report.
The experience acquired by the ATLANSTAT team in the drafting of protocols, submissions and obtaining regulatory authorisations guarantees a controlled start of the studies. The monitoring allows to keep this quality requirement.
A crucial step in a trial, randomisation allows to avoid selection bias, to ensure comparability between the different groups and to legitimise the use of statistical tests. ATLANSTAT has a proven statistical methodological expertise as well as an operational know-how in the implementation of IWRS (Interactive Web Response System).
ATLANSTAT masters the clinical data management process in compliance with international recommendations (EMA, ICH, FDA). It allows the complete management of the data of a study, from the elaboration of the CRF with the help of the protocol to the final database, validated, for a statistical analysis of quality.
With a highly qualified biostatisticians and statistical programmers team, we are regularly asked to define statistical methodology, write protocols, produce and interpret statistical results or participate in DSMBs (Data Safety Monitoring Board)