Due to the constantly increasing requirements for study documents of all kinds (concerning form and content), the professional preparation before study start is becoming more and more a decisive factor. Documents that are not only accurate and correct, but also clearly structured, facilitate cooperation with authorities, ethics committees, study sites and patients.

We will be glad to support you in preparing:

  • Study protocols (Phase I – IV)
  • Observation plans (NIS / PASS / PMOS)
  • Clinical investigation plans (CIP) for medical devices
  • Additional study documents, e.g. patient information and informed consent, manuals, etc.
  • Data collection forms, other than the CRF, such as questionnaires or patient diaries
  • Documents for submission to ethics committees or competent authorities
  • Standard operating procedures (SOPs) - tailored to meet your specific needs
  • Interim reports
  • Final reports / Clinical study reports for clinical trials with medicinal products and medical devices
  • Reports for non-interventional studies, questionnaire studies, retrospective data collections and many other research projects
  • Study progress reports
  • Investigator’s Brochure (IB)
  • Lay Summaries

The work with study participants often represents a special challenge. If required, we also provide patient information and informed consent or patient diaries in "simple language" according to current guidelines in order to avoid communication problems or misunderstandings. Through our cooperation with certified translation service providers, documents for study participants can be prepared in all common languages.

CW-Research & Management GmbH is member of the European Medical Writers Association.