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.
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Medical Writing
Synopsis, protocol, clinical investigation plan,
Clinical Evaluation Report, Clinical Evaluation Plan,
end of study report, scientific communications (abstract, poster, publications) -
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) -
Biometry
Data Management (Ennov Clinical System)
SAS programming platform
Biostatistics team
Tools validated according to Gamp5 recommendation -
Investigation
site supportRisk-based monitoring approach
Remote monitoring
Home-based in regions -
Coordination with the PI
Data entry and patient management
Support the site during monitoring visits -
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…).
