Clinical investigations before and after CE marking
The new European Regulation on medical devices aims to ensure a high level of health protection for patients and users by taking into account the diversity of existing medical devices and the large number of companies active in this sector.
The regulation is based on four pillars: the reinforcement of the obligations of the notified bodies (NB), a European database of medical devices, a reinforcement of the cooperation between the member states as well as the reinforcement of the obligations to carry out clinical investigations before the marketing.
In this context, ATLANSTAT has been able to adapt its services to Medtechs by guaranteeing a quality level adapted to their regulatory requirements.
Many projects have been conducted by ATLANSTAT in this field with prospective or retrospective clinical investigations
These projects have involved both pre-CE marking investigations or plans in line with the requirements of the post-marketing clinical follow-up (PMCS).
ATLANSTAT also has experience with projects evaluating an in vitro diagnostic medical device (IVDD).
The implementation of prospective studies follows a quality level equivalent to that of drug development
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)
I had the pleasure of working with Atlanstat to establish the statistical analysis plans for several clinical studies (alcohol dependence and migraines) and to conduct the corresponding analyses. ATLANSTAT has perfectly fulfilled these missions with a lot of professionalism and a remarkable expertise and we were able to reach our objectives. Thank you very much!