PUBLICATIONS, CASE STUDIES AND EXPERIENCES

Experience, reliability, responsiveness in clinical and epidemiological research

  • We design and implement any type of drug study

  • Phase I to phase IV clinical studies

  • Non-interventional studies in the form of registries, observatories and cohort studies

  • Cohort ATU and RTU, compassionate studies (Early Access Program)

  • Epidemiological, pharmaco-epidemiological and health economics studies

  • We have all the expertise and services internally

  • We are referenced by several major international groups

  • We conduct academic promotion studies, funded by the industry or otherwise

  • We design protocols and CRFs in collaboration with scientific committees and customers

  • We prepare and manage regulatory submission dossiers in all countries

  • We offer advanced technical solutions for data collection (eCRF, ePRO applications, specific scoring, pedagogical tools, mobile terminal applications)

  • We offer centralised and/or onsite monitoring depending on the study

  • We can help investigator sites by delegating CRTs on-site

  • Our biometrics department is composed of several data managers, statisticians, methodologists and data entry operators

  • We design and implement studies or data collection

  • We perform studies at the CE marking stage and post-marking, for requesting reimbursement in France, for meeting the post-registration requirements of HAS [the French National Health Authority]

  • We have all the expertise and services internally to perform a study integrally

  • We can support manufacturers preliminary to CE marking

  • Our internal and external consultants can prepare dossiers for marking and reimbursement in France

  • We design and hold seminars and training on topics related to our expertise in health studies and data analysis

  • We provide technical solutions (eCRF, ePRO, IWRS randomisation, apps on smartphones and tablets, development of specific applications)

  • Consulting and assistance to meet study demands by authorities

  • Methodological consulting in developing protocols

  • Medical writing: study reports, abstracts, posters, scientific articles

  • Help with finding study funding

  • We design and implement studies or data collection

  • We perform studies at the CE marking stage and post-marking, for requesting reimbursement in France, for meeting the post-registration requirements of HAS [the French National Health Authority]

  • We have all the expertise and services internally to perform a study integrally

  • We can support manufacturers preliminary to CE marking

  • Our internal and external consultants can prepare dossiers for marking and reimbursement in France

  • We design and hold seminars and training on topics related to our expertise in health studies and data analysis

  • We provide technical solutions (eCRF, ePRO, IWRS randomisation, apps on smartphones and tablets, development of specific applications)

  • Consulting and assistance to meet study demands by authorities

  • Methodological consulting in developing protocols

  • Medical writing: study reports, abstracts, posters, scientific articles

  • Help with finding study funding