Assessment of health benefits for patients
The new European regulation on medicinal products does not apply to clinical studies outside health products.
ATLANSTAT has acquired a solid expertise in the management of clinical studies in nutrition and cosmetology.
The specificity of these studies is that the direct measurement of the efficacy on the health of the volunteers is often not directly measurable. Either it takes time to be quantifiable or it requires indirect measurements using markers.
The use and analysis of quality of life questionnaires has also developed significantly in clinical studies in health nutrition for the same reason.
Authorised health claims are listed in the EU Register of Nutrition and Health Claims. This is regularly updated to incorporate EU decisions to authorise or refuse new health claims.
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)
We have been working with ATLANSTAT for many years. We appreciate their reactivity, our constructive exchanges and their constant reliability. The team is well established and experienced. In 2 words, our collaborations are simple and efficient, and we appreciate them.