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).

Randomisation- Randomization test

Randomization test to leave nothing to chance

ATLANSTAT offers a set of services to manage the randomization and product allocation process of
any study and uses the same tool as for data management: ENNOV CLINICAL.

A single web interface can therefore be set up for randomization (IWRS) and study data collection (eCRF).

Learn more about our other expertises : Data management, Biostatistics, Medical writing.

logiciel de randomisation ennov

A validated randomization process ensuring double-blinding

  • Expertise on the choice of randomization scheme (method, design, stratification factors, etc.)
  • Adaptability to the specificities of the study (inclusion/exclusion criteria, modalities of the randomization test and treatment allocation,)
  • Generation and validation of randomization/treatment lists
  • Randomization test by minimisation or by randomization list
  • Management of treatment stocks in the different sites
  • Provision of a secure web interface I.W.R.S. (Interactive Web Response System)
  • Quick and easy access (no software installation and/or purchase required),
  • Intuitive ergonomics designed to limit investigator input errors,
  • Progress reports
  • 24/7 support available via a hotline
  • Automatic audit trail recording all actions performed for the study

Testimony of the team

I am a Data Manager at ATLANSTAT and part of my job is also to put randomization applications online.

The first part of the work consists in setting up the IWRS (Interactive Web Response System) in order to take into account all aspects of the methodology described in the study protocol. Many parameters have to be considered: the number of sites, minimisation or block randomization, stratification factors and their coefficients, balanced or unbalanced distribution by treatment, number of allocations per patient, parallel group or cross-over design, and many others…

I may also be in charge of managing the supply of treatments to the investigating sites to ensure that they always have in stock the treatments that the system will allocate to them.

This implies a particular responsibility for the proper conduct of randomization and patient follow-up, as well as the obligation to maintain double-blindness, so that each patient can be treated with the planned treatment.

Virginie VALLAIS, Data Manager in charge of randomization

Our references

CHU Nantes