Patient Safety Narratives & White Papers Submission

Patient Safety Narratives & White Papers

E-Merge has several years of experience in preparing concise and well-structured patient safety narrative writing documents and white papers with data supported by facts, figures and statistics to explain the problem and its potential solution. Our patient safety narratives will have a brief summary of the adverse events practiced by the patients during a clinical trial of a drug along with the clinical study report to establish any causal relationship between the events practiced by the patient and the drug under investigation.

Our Expertise

  • Consistency in Patient Safety Narratives
  • Gain Quality, Consistency, and Standardization, Narrative Template Submission
  • To provide Persuasive and Factual / Technical Evidence
  • Develop and Document Compliant Risk Assessments to Comply under ICH GCP E6 (R2)
  • Areas Explored in this Whitepaper are
    • Information Sources
    • Future Directions
    • Additional Considerations
    • Individual Case Safety Reports