We help you design and produce all your clinical research project documents:
As per current formatting standards (ICH)
– With utmost rigour and clarity
– In French, English and other languages

Our medical writers (Doctors of Science or Pharmacy) examine in depth the health issue addressed by your project to advise you and create the relevant documents:
– Regulatory documents
– Materials for investigators and field staff
– Medical communication tools

Project groundwork

We offer to:

Analyse medical and scientific literature related to your research subject
Contact experts and bring together the scientific committees providing the scientific stamp of approval for your project
Produce a synopsis including:

  • A short bibliographic summary
  • Study design
  • A definition of the objectives
  • The main evaluation criteria and the data to be collected (scales, scores, questionnaires, etc.)

Methodology support

– We advise you on the study design most adapted to your objectives (interventional or observational study, longitudinal or transversal, comparative or descriptive, etc.)
– We calculate the number of trial subjects required to attain study objectives (superiority, non-inferiority and equivalence hypotheses for comparisons, descriptive hypothesis, etc.)
– We offer statistical analyses in relation to your objectives enabling you to exploit collected data effectively:

  • Descriptive analyses (efficacy, tolerance, compliance, survival, etc.)
  • Exploratory analyses (correlations, logistic regression, analysis of variance, principal component analysis, etc.)

We also assist in other types of project:
Bibliographic summary, scientific monitoring
– Clinical evaluation reports to accompany CE marking applications for medical devices (MEDDEV format)
Consumer surveys, medico-marketing and pharmacoeconomic studies, etc.

Study initiation

We produce all the documents required to initiate your studies:
– Synopsis
– Protocol (ICH or customised format)
– Case Report Form
– Patient information sheet
– Informed consent form
– Investigator’s brochure
– Statistical analyses plan
Regulatory submission documents

Documents are written directly in French, English or other languages (linguistic validation by a specialist translator on request).

End of study

At the end of the study, when the data management steps have been completed, we produce the following documents:
– Data review listing
Statistical report
Clinical study report (ICH or customised format)
Presentation of results (slide show)

Documents are written directly in French, English or other languages (linguistic validation by a specialist translator on request).

Medical communication

To exploit the results of  your study, we also produce:
Newsletters for investigators, during or at the end of the study
Abstracts to be submitted for congresses
Posters or ePosters
Slide shows for giving live presentations of results
Articles for peer review committees (complying with CONSORT, STROBE, etc. standards)
Brochures for marketing/sales teams
– Press releases/kits
– Etc.

Documents are written directly in French, English or other languages (linguistic validation by a specialist translator on request).