DRIVING FOR SUCCESS

Talented and Enthusiastic Consultants from QUINTESSYS will support your projects for the following roles:

MEDICAL WRITING

  • Our MEDICAL WRITERS are experts in the preparation of all types of Regulatory documents.
  • Expertises in the preparation of clinical development documents (protocols, investigator brochures, informed consent forms, clinical study reports), packages for marketing authorisation request (clinical overiew and clinical summaries, ISS, ISE) and life-cycle management documents (addendum to clinical overviews, updated clinical overviews)
  • Experts in the preparation of various briefing documents (PIP, meeting request to Agencies) and of various safety documents (RMP, DSUR, PSUR/PBRER).

Biostatistics & Programming

  • Our BIOSTATISTICIANS & PROGRAMMERS have deep experiences in tailoring the right analyses to your studies.
  • Reliables and flexibles

« Being flexible, listening to colleagues and making decision on-time, this is how QUINTESSYS will support you in addition to our expertises. »