Implementation of the new European regulation 2014/536
Since its creation, ATLANSTAT has worked with major pharmaceutical companies, particularly for its Data Management and Biostatistics missions and has a strong experience in Oncology in this context.
The company has also developed its missions in clinical operations, in particular in connection with the new European regulation 2014/536.
It has also been able to contribute to the obtaining of Temporary Use Authorizations (TUA) or Temporary Use Recommendations (TRI).
In recent years, large pharmaceutical groups have increasingly changed their strategies and directed their research towards rarer diseases and more individualized applications.
Indeed, the rise of generic drugs and biosimilars coupled with the rise of Biotechs has changed the panorama of research in human health.
Recently, new paths of research have been opened up, notably through bioinformatics and more generally through data science.
Thanks to its experience in statistics and computer science, ATLANSTAT develops new models in line with these new ways of proving the efficacy and tolerance of products.
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)
After a 23 years career in a CRO specialized in early clinical development, leading me to design, develop protocols and conduct Phase I studies for big and medium size Pharma but also for many biotech companies, I started a consulting activity which led me to build a network of CROs specialized in conducting Phase I studies.
It is in this context that I selected ATLANSTAT for the activities of Data-Management, Statistics and Monitoring. After a very fast and constructive bilateral learning phase, during the first two projects, I thank the ATLANSTAT teams for their professionalism, reactivity, flexibility and quick capacity to adapt to the unexpected situations inherent to Phase I studies and especially to the first administration in humans. From my point of view, this partnership is a success thanks to their reactivity and flexibility without impacting the respect of rules and good practices, which is rare.