IDDI, Biostatistical and eClinical Services for Clinical Trials

TRIAL DESIGN - RANDOMIZATION - DATA MANAGEMENT - BIOSTATISTICS
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Medical writing

Medical Writing is more than a service - it's a skill and an art!

IDDI has long recognized this and chosen to work with external medical writers who have the expert scientific background, the knowledge of the therapeutic domain and the skills to structure documents clearly and accurately while also adhering to the appropriate guidelines and regulations.

The statistical analyses performed will be used to prepare a registration dossier for marketing approval, a presentation at a medical conference, or a publication in the medical literature.
 

Services:
 

  • Protocol Writing
    IDDI provides the best statistical design for your trial and will work with the relevant clinicians to provide the treatment schemes into a full protocol written by a dedicated Medical Writer.
  • Investigator Brochures
  • Clinical Study Reports and appendices according to the ICH-E3 guideline "Structure and Content of Clinical Study Report"
    Clinical data are presented with a statistical analysis and complete appendices in an integrated report, using either your standard template or IDDI's template following ICH guidelines. At your convenience the final integrated reports are delivered in PDF format or as hard copy.
  • Publications
    From your raw data, we produce a publishable manuscript that follows "instructions to authors" of the journal you have selected. After submission, we will also handle the corrections and the response to the reviewers
  • eCTD for submission
    When applying for a product license, we can help you prepare the clinical parts of the Common Technical Document (CTD) submitted to regulatory authorities in the US, Europe, Japan and Canada

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