Clarity and readability.
Deliver clear and concise safety narratives.
An effective subject narrative presents a clear and concise explanation of any deaths, Adverse Events (AEs) leading to study drug discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESIs) experienced by an individual subject during a clinical trial. The clarity in story and readability allows reviewers to properly assess the drug’s role in the occurred events. CDM is experienced in reviewing patient data listings and weaving in information from CIOMS reports to write comprehensive subject narratives. CDM works with clinical teams to establish formatting guidelines that meet both project-specific and regulatory expectations. Our team implements a rigorous QC/QA process to ensure the accuracy of all reported data.