Epidemiology

Pharmaco-economic studies, PAS studies, studies required by HAS, observatories, or non-interventional studies; i.e. the regulation is evolving, the administrative approaches are changing, requirements are being made more stringent.

• Is the project in or out of the scope of the Public Health Law, and what are the requirements that might make it applicable?
• What are the administrative steps to be followed (CCTIRS, CNIL, Afssaps, CPP, CNOM, etc.)?
• Should the hospital directors be informed?

SUNNIKAN Consulting:

• Gives punctual answers to specific questions (regulatory assistance)
• Ensures monthly distributed regulatory intelligence
• Designs and writes procedures, standard documents, specific job descriptions that are applied to the epidemiological field, and ensures that documents are in compliance with current French and European regulations
• Conducts audits of systems (the management of epidemiological studies, data management, etc.); of providers (qualification or follow-up); and of studies (documentation audits and site audits)
• Trains teams on procedures and on regulations applicable to the epidemiological field (internal or external training)