Medical Writing for Submission-Ready Results
Clear, accurate documents support regulatory success. Our medical writers deliver everything from a single document to full writing programs, from protocol synopsis to clinical study reports and journal publications.
Choose How You Work
Full service
Medical writing delivered as part of your full-service Worldwide clinical trial across the program.
Functional service (FSP)
A dedicated writing team for your portfolio, working with your templates and style guides or ours.
Individual specialists
Resource augmentation with experienced medical writers who join your team to provide added capacity and specific expertise.
Services
Regulatory and clinical documents
Protocols, clinical study reports, investigator brochures, DSURs, narratives, and briefing documents
Publications
Journal manuscripts and scientific communications
Transparency and disclosure
PPD redaction rule tables, CCI consultation, redacted CTIS Part I and II packages, EMA Policy 0070 compliance, and GDPR redaction of TMF documents
Plain language
Plain language summaries, patient recruitment materials, and public health information
Evidence and market access
HEOR, real-world evidence, and health technology assessment support
Technology-enabled authoring
Machine-augmented authoring and literature searches by expert writers
Why worldwide
Built-in quality.
Every first draft goes through QC, writer peer review, and subject matter expert review before it reaches you, with a full QC before finalization.
Your standards or ours.
ICH-compliant templates and a comprehensive style guide, or your own.
Global team.
Writers across Europe and North America, all members of EMWA or AMWA, supported by document coordination specialists.