AKP

Medical Writing

In close collaboration with the sponsor we support you in developing a feasible study design through combining your ideas with our experience.

When planning clinical trials (AMG / MPG), IITs or NIS, clearly structured study documents are required right from the start to optimise the time for review and approval as well as to facilitate the implementation of the study procedures.

In cooperation with our sub-contractors we can offer the writing of the following study documents:

• Protocols, including synopses and amendments
  
• Observational plans
  
• Submission documents to national authorities and Ethics Committees
  
• Patient information sheets / Informed Consent Forms
  
• (Electronic) Case Report Forms / (e-)CRFs
  
• Patient diaries
• Study manuals (laboratory, investigators, monitoring)
• Newsletters
• Clinical Study Reports (CSRs)
• Training materials
• Publications
• Abstracts

Additionally we can support you in:

• Professional literature research
  
• Proof-reading of existing documents
  
• Medical review of safety data
  

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