Assessment & Recommendations on Improving Clinical Documents

Ten tips for medical writers – for improving your Clinical Documents

  1. Know the purpose/reader of the document.
  2. Start with good precursor documents
    (CSP for CSR, CSR for summaries etc.).
  3. Make sure conclusions reflect objectives/aims.
  4. Use document hierarchy to provide navigation
    (TOC, headers, cross-references).
  5. Check for consistency of technical writing style – terms, formatting, presentation etc.
  6. Present main messages using tables and graphs – effectively label all parameters.
  7. Define study/analysis populations – use flow charts to explain patient populations.
  8. Demonstrate efficacy – how does the treatment benefit the intended patient.
  9. Explain safety precautions – what is the risk of the treatment, signal among the noise.
  10. Analyze subgroups with caution due to their lack of statistical power.

Do you have clinical documents you’re unhappy with but don’t know how to fix? Then let Trilogy help you…

Set up a CDA and send us your document! We will review it and provide practical recommendations for communicating your results effectively and concisely… you can act on our advice, or have your medical writer or us do it for you. We will typically send you our assessment within 3-5 working days. Since your documentation is the only part of a development the regulatory reviewers ever see – it’s worth investing to make sure it’s right.

Contact us to discuss your document and what we can do to review it in more detail.