Medical Writing Across the Drug Development Lifecycle
From preclinical reporting through commercialization, Maven delivers world-class medical writing across therapeutic areas and document formats. Our writers manage timelines, coordinate authorship meetings, and reconcile sponsor feedback to produce scientifically cohesive materials with minimal supervision.
Flexible Engagement Models
We offer standalone document support or full-service writing programs, including functional service provider (FSP) partnerships. Our team collaborates with in-house writers to offload routine tasks and focus on strategic content development.
Services for Individual Studies
- Protocols and amendments
- Informed consent forms and patient information leaflets
- Clinical trial reports (full, abbreviated, interim, synoptic)
- Safety narratives
Regulatory Writing Across Studies
- Briefing documents
- Annual reports
- Investigators’ brochures
- IND, NDA, CTD submission dossiers
- Risk profiles and regulatory responses
Aggregate Safety Reports
- DSURs, PSURs, PBRERs
- Signal analyses and line listings
- Local safety summaries (LSSs)
- Risk management plans (RMPs)
Publication Writing
- Medical publications and review articles
- Primary publications and strategic support
- Resubmissions and reviewer responses
- Manuscripts, slide kits, literature reviews
- Oral presentations, posters, abstracts
Medical Editing
- Formatting and editing using style guides
- Grammar, spelling, and readability improvements
- Quality checks against source data
- Submission-ready regulatory documents
Specialized Services
- Clinical trial registry support
- Medical information letters
- Document redaction and publishing
- Advisory committee slide creation
- Lay language documents
- Clinical trial transparency and disclosure
- Document project management
