Clinical Executive Summary

A clinical executive summary (CES) is a concise document that provides a high-level summary of information regarding a specific product. It presents the most recent, relevant, scientifically accurate and balanced information regarding efficacy, safety, and health economic and outcomes research data. It includes key clinical differentiating factors such as pharmacodynamic and pharmacokinetic data that help with formulary decision-making. It may also provide additional information to supplement the Prescribing Information, such as patient satisfaction and compliance data, post-marketing safety updates, relevant advisory meeting decisions, and healthcare utilization. A standard CES typically includes on-label and published information, unless otherwise requested by the stakeholder. Key sections of the CES include:

  • Overview of the product
  • Indications and dosing
  • Distinguishing characteristics
  • Clinical data
  • Health economic and outcomes research data
  • Safety

Med Communications’ Scientific Content team is highly skilled at developing quality content for the CES. The team is also adept at reviewing and updating the CES when any of the following instances occur:

  • Changes to the prescribing information
  • New clinical or health outcomes research data
  • New safety information
  • Demonstration of real-world effectiveness

Our team of highly experienced and knowledgeable scientific writers can help facilitate and optimize evidence-based formulary decision making through communication of key clinical and health outcomes data. We are committed to helping our pharmaceutical industry clients and healthcare providers ensure the effective use of products that improve the overall quality of life of their patients.