Services

Medical Writing

The GCP ICH E6 (R3) and EU Regulation 536/2014 describe essential documents which are crucial prior, during and after conducting clinical trials. With our great expertise in all relevant document types, we can support you in your project:

Prior to approval

  • Trial Design Outline (TDO) & Trial Protocol (CTP)
  • Investigators Brochure (IB)
  • Informed Consent (IC)
  • Clinical report form (CRF/eCRF)

During the trial

  • Amendment (e.g. changes to the protocol)
  • IB update

After trial conduct

  • Clinical trial report (CTR)
  • Biomarker Report
  • Publication
  • Slide deck generation

Quality control of documents

  • Completeness and consistency
  • Fulfilment of sponsors requirements
  • Formatting and layout
  • In-text tables/figures

We would be happy to answer your questions about our services personally.

contact@marco-institut.de