Our Expertise

medical writing

Medical Writing

Medical writers are critical to the communication process of outlining the goals, strategies, analysis, and medical understanding of a clinical trial/program to patients, sites, sponsors, and regulatory agencies. Our successful clients cite these reasons for choosing to work with us.

  • We offer medical writing services in a wide range of therapeutics areas performed by experienced medical writers with PhD-level degrees in life science and over 10 years of experience. These include study-specific documents and development-program documents.
  • The medical writing service is fully integrated into multi-disciplinary clinical development teams, specifically safety, biostatistics, and data management.
  • Our scientific-minded writing team has significant experience preparing clinical documents, including protocols, clinical study reports (CSRs), and Investigator’s Brochures.
  • We excel in developing regulatory documents to support drug, biologic, device, and diagnostic marketing submissions to regulatory agencies worldwide.
  • We understand the complexities of writing in a highly regulated environment and the challenges of varied requirements of different regulatory agencies.

Medical Writing for Clinical Trials & Regulatory Submissions

medical writing

We provide medical writing support for the full life-cycle of a product’s development, beginning with early-stage development through marketing application and post-approval. We offer rapid turnaround to meet tight timelines, and flexible, efficient processes for any project large or small. Using in-house or sponsor-supplied document templates, we apply best practices for content, format, and style to meet global technical and regulatory requirements. Our expert medical writing team supports the development of the following types of documentation:

Clinical Trial & Program Documentation

  • Protocol Synopsis, Protocols, and Amendments
  • Informed Consent Forms
  • Clinical Study Reports (CSRs)
  • Safety Narratives
  • Clinical Development Plans
  • Investigator Brochure and Patient Information Leaflets
  • Annual reports
    • Periodic safety update reports (PSURs)
    • Development safety update reports (DSURs)
    • Periodic benefit-risk evaluation reports (PBRERs)

Regulatory Submission Documents

  • Marketing Applications in eCTD format (including IND, CTA, NDA/sNDA, MAA, NDS, jNDA)
  • Clinical & Non-Clinical Summaries (Module 2)
  • Integrated Summaries of Efficacy and Safety (Module 5)
  • Responses to Agency reviewers
  • Regulatory Briefing documents for Agency meetings, including:
    • Pre-IND, End of Phase 1,  End of Phase 2/3, Pre-NDA  and  Advisory Committee
  • Orphan Drug Designation Applications
  • Risk Management Plans

eCTD services

medical writing
  • Create and edit eCTD documents according to ICH and national regulatory authority guidelines.
  • Manage documents and eCTD sequence lifecycles on a  dedicated Document Management System in accordance with regulatory requirements.
  • Create and publish eCTD sequences on a dedicated eCTD compilation system in accordance with regulatory requirements.
  • Validate eCTD sequences using specialized validation tools in accordance with ICH and national regulatory authority validation criteria.
  • Submit eCTD sequences to regulatory agencies.

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