Regulatory writing
- Statistical Analysis Plans (SAPs)
- Clinical Study Reports (CSRs)
- Protocols and protocol synopses
- Statistical reports
"There's no precedent for this approach in our indication."
SAPs, CSRs, and publications written the way reviewers read them: documents that match the analysis exactly and hold up under scrutiny, on your budget and your timeline.
Discuss a document
We frequently partner with client teams at any document or publication development stage. Our team understands regulatory agency expectations and is expert in AMA-style writing. Involvement can range from creating initial outlines to conducting final validation and managing regulatory or journal submissions.
Comprehensive outline planning
Statistical interpretation
Section-by-section reviews
Overall flow, objective analysis & formatting
Statistical analysis plans (SAPs), clinical study reports (CSRs), literature reviews, abstracts, posters, presentations, and original publications.
Our medical writing team is flexible: we can use Pentara templates or sponsor templates, and customize our work based on your needs and budget.
We may provide the framework to start your team off, or the final review to validate a document your team produced. We offer statistical reviews, comprehensive reviews, section-by-section content review, and journal submission with appropriate formatting.
Least expensive point to bring us in · Regulatory meeting
Briefing package and anticipated questions. Later, it is a question you can't answer on the day.
Tell us the document, the deadline, and the budget, and we'll scope the right level of support.