Our mission

CEN’s mission is to bring evidence of efficacy and safety of your medical devices or medications in order to register them and/or to publish on them in peer review medical journals. For that we offer an integrated solution covering all stages of a clinical trial or an observational study from conception to publication of its results, including:

  • Study of the regulatory framework of the study and the administrative and legal steps that it will have to meet, as well as the promotion of the results;
  • Identification of the main objective and evaluation of its impact on the design of the study, the sample size and the costs.
  • Preparation of the study protocol and its annexes, submission to regulatory authorities that its implementation implies;
  • Investigators recruitment
  • Setting up studies according GCP ICH3 with the use of audio-visual techniques which is one of the  CEN Biotech specificity;
  • Monitoring of studies and data collection according to ICH3 GCP;
  • Double data entry on “Capture system” which is a software allowing auditability of all data acquisition and transfer operations;
  • Definition of the statistical analysis plan and implementation of the analysis with SAS statistical and report writing (ICH3);
  • Clinical report writing of clinical trials, pharmaco-epidemiology and health economics, studies and Risk Management Plan;
  • Administrative and financial management of the study and payment of medical fees;
  • Writing national or international abstracts and publications.