Litto Communications LLC

Literature Searching

• Comprehensive searching of the medical literature
• Critical evaluation and interpretation of the medical literature using principles of evidence-based medicine

Analytical Services

• Critical evaluation of technical data
• Drug and medical device reviews
• Disease state and therapeutic category reviews
• Drug label reviews and comparisons

Medical Writing

• Preparing annotated outlines
• Creating new documents and updating existing documents
• Assembling bibliographies
• Designing tables and figures for data display
• Regulatory writing for CTD-compliant documents 
• Experience with AMA style, ICH and GCP guidelines, and AMCP dossier format

Editorial Services

• Fact checking, copyediting, and proofreading
• Designing document templates 
• Application of style guidelines
  • AMA Manual of Style
  • AMCP Format for Formulary Submissions, Version 4.1
  • ICMJE recommendations

Medical Education Programs

• Planning, designing, and managing pre-and post-launch programs for healthcare professional audiences

Consulting

• Designing and implementing special projects in medical affairs and drug information

Project and Document Experience 

Clinical Development

• CTD clinical overview and clinical summary (ICH M4E)
• CTD clinical study reports (ICH E3)
• Clinical trial protocols (ICH E6)
• Investigator’s Brochures (ICH E6)

Medical Affairs

• Managed care formulary dossiers for submission to health systems (AMCP format)
• Publication writing
  • Manuscripts for peer-reviewed journals
  • Abstracts and posters for medical meetings
• Monographs   
• Slide lectures / presentations
  
• Article summaries

Medical (Drug) Information

• Medical response documents
• Response document formats and templates
• Product bibliographies
• Product claims compendia 
• Quality assurance support, including cyclical reviews and updates of response documents
• Response document planning