In the context of developing an immunosuppressive drug for post-renal transplant patient, a global leader in generic and biosimilar medicines outsourced the study of the benefits of the pharmacokinetics profile of its product to AIXIAL (specialized subsidiary of ALTEN Group).
As a company expert in clinical trial and vigilance services, AIXIAL provides a workpackage based service, covering the whole project in different sites in Europe:
- Clinical operations management: identification of 13 sites, feasibility studies, contract management, ethic and regulatory submission, risk based monitoring, project and vendor management…
- Clinical Data management (bio-statistics, CRF programming and management…)
- Medical writing (clinical study reports, statistical reports…)
With its strong know how in local regulations and offices in different European countries, AXIAL is able to assign local engineer teams to manage local activities in different sites and agencies.
This field office proximity allowed AIXIAL to be reactive to our customer’s requests and to provide a competitive and efficient clinical trial management solution.