Biotechs, innovative health research companies
If the aim of the new European regulation is to better control and secure patients’ health, it introduces an additional regulatory complexity.
Biotechs are companies that use or modify living materials to create innovative products or services. They are related to the health sector: research for vaccines or gene therapies, manufacturing of drugs, etc.
More than 50% of French biotech companies were born as a result of academic research. Partnerships with the research world continue after the creation of the companies, which favors innovation.
ATLANSTAT plays an essential role in this context because its experience allows Biotech companies to be advised quickly on the various regulatory aspects for the development of their innovative product.
Indeed, these companies need a reactive, experienced and flexible partner.
The studies are carried out with the same missions and the same requirements as for a pharmaceutical client.
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)
Quantum-Genomics chose ATLANSTAT for the data management and the statistical analysis of its phase 3 studies. For a biotech company like Quantum-Genomics, it is very important to be able to work with a human-sized company, allowing a fast and direct access to the people involved in the project and able to understand the problems of a small structure like ours. Our experience on the two current studies meets our expectations, the ATLANSTAT team is particularly motivated and competent, interacts regularly with our teams and adapts easily to our new requests with a great reactivity.