02 Services / Products

Tailored solutions

Our CRO services can be tailored to your specific needs. You can contact us for direct services for you alone, or for you and your partners.

  • Medical Writing

    Document writing
    (synopsis, protocols, patient information leaflets, CRF, protocol for therapeutic use and data collection)
    Report writing
    (clinical reports, periodic reports related to early access programs)
    Showcasing of results
    (publications, posters, abstracts)
    Creation and revision of regulatory applications
    (CTDs, CERs)

  • Regulatory Affairs

    Regulatory advice on clinical studies or investigations
    Preparation of the submission package (Directive 2001/20/EC) or CTIS (European Regulation No. 536/2014)

  • Biometrics

    Data Management (Ennov Clinical software)
    Documentation (DMP, DVP)
    Data entry platform with edit check programming and query management
    Randomization (IVRS, IWRS)
    Data coding based on MedDRA & WHODrug
    Registry generation, data review (blind review) and database locking
    Import of external data (biological test results, compliance, medical device)
    SDTM Mapping (CDISC)
    Writing of the protocol’s statistics paragraph with calculation of the number of subjects required
    Writing of the statistical analysis plan with a list of TFLs
    Programming of analyses and generation of statistical tables
    SAS programming platform
    Tools validated according to Gamp5 recommendations

  • Monitoring (CRA)

    Site initiation
    on site or remote – individual or global
    On-site or remote monitoring visits
    with reports and action plan follow-up
    Quality control visits
    for observational studies
    Site management
    query management, motivation, reminders and site support throughout the study
    Site close-out visits
    on site or remote

  • Investigation site support (CRT)

    Screening, contacting patients, organizing appointments, patient follow-up
    Data entry in the e-CRF
    Help with managing DCFs
    Stock management (CRF, kit, forms)
    Various administrative tasks
    Presence during monitoring visits

  • Vigilance

    MD vigilance
    Vigilance for clinical trials on “non-health products”

  • Project management

    A dedicated team and a single point of contact for each project
    Experienced managers
    Quality assurance control
    Management plan preparation and updating
    Coordination of tasks, resources, scheduling and the budget
    Risk management approach


Our teams are flexible when it comes to using sponsor (industrial or institutional) or Euraxi procedures on a project. They are quick to adapt, having already worked with a variety of shared directories (sharepoint), eCRFs (Medidata Rave, Ennov), eTMFs (implemented in client systems) and IRTs (Calyx, Almac).