02 Services / Products

A la carte solutions

Our CRO services are fully adaptable to your needs. You can contract us for direct individual services or associated with your other partners.

  • Regulatory Affairs

    Regulatory advice for clinical studies or investigations
    Preparation of the submission package (directive 2001/20/EC) or CTIS (European regulation n°536/2014)

  • Coordination with the PI
    Data entry and patient management
    Support the site during monitoring visits

  • Investigation
    site support

    Risk-based monitoring approach
    Remote monitoring
    Home-based in regions

  • Biometry

    Data Management (Ennov Clinical System)
    SAS programming platform
    Biostatistics team
    Tools validated according to Gamp5 recommendation

  • Medical Writing

    Synopsis, protocol, clinical investigation plan,
    Clinical Evaluation Report, Clinical Evaluation Plan,
    end of study report, scientific communications (abstract, poster, publications)

  • Vigilances

    Pharmacovigilance
    Materiovigilance
    Vigilance of clinical trials “Excluding health products”
    Cosmetovigilance
    Nutrivigilance

  • Project management

    Preparation and maintenance of the management plan
    Coordination of activities, resources, planning and budget
    Risk management approach

SOPs

Sponsor (industrial or academic) or Euraxi procedures, our teams will be flexible with a number of opportunities to work with various shared repositories (sharepoint…), eCRF (Medidata, Ennov…), eTMF and IRT systems (Calyx, Almac…).