Medical Writing and Quality Control

Medical writing and quality control (QC) services are a core offering at inSeption. We custom build our teams from an elite group of medical writers who have extensive experience in all phases of clinical development and across a broad range of therapeutic areas.

Submission planning requires an experienced, fully dedicated partner who can integrate within the organization to credibly manage the complexities of timeline creation, project and resource management, interdependencies, writing, QC, and publishing.  We can prepare documents using our suite of ICH-compliant templates and style guide, using Sponsor-provided materials, or with a custom solution that best fits a client’s needs.

Our highly skilled medical writers author clear and concise documents that are sound from both a scientific and regulatory perspective. We have standard operating procedures (SOPs) in place to ensure all documents undergo thorough QC reviews prior to delivery.

inSeption has extensive experience authoring clinical components of global marketing applications, including New Drug Applications (NDAs) and Biologics License Applications (BLAs) in the US, Marketing Authorization Applications (MAAs) in Europe, and rest of the world (ROW) submissions.

Overview of expertise:

  • Marketing Applications:
    • Integrated Summaries of Efficacy (ISE) and Safety (ISS)
    • Module 2 summaries (eg, Module 2.5, Clinical Overview; Module 2.7.3, Summary of Clinical Efficacy; and Module 2.7.4, Summary of Clinical Safety)
    • Nonclinical and Clinical Pharmacology Summaries and Overviews
  • Clinical Study Reports (CSRs) across all phases of development
  • Investigational New Drug Applications (INDs) and IND amendments
  • Orphan Drug Applications and Annual Reports
  • Investigator’s Brochures
  • Clinical protocols and amendments
  • Safety narratives
  • Development Safety Update Reports (DSURs)
  • Briefing documents to Health Authorities