Multiple tools. One workspace. Built around regulated documents.
Every ProWriter feature was designed to answer the same question: how do we get a clear, well-grounded, submission-ready document out of a team of experts, faster, with fewer errors, and with the references, figures, and revisions all in one place?
Templates.
FDA-grade, from draft one.
Every ProWriter template lays out the sections for the document you are writing, with per-section instructions and grounding so each section stays anchored to your sources rather than the open internet.
- Templates for CSR, CSP, IB, NDA , ICF, narratives, and more
- Section structure and instructions built into each template
- Always grounded in your reference library, never the open internet
- Build your own template & share with your team
The primary efficacy analysis was conducted on the Full Analysis Set (FAS), comprising all 240 randomized subjects who received at least one dose of study drug.[protocol Sec. 6.1]
Expert Consultations.
Vetted. By the hour.
Book regulatory experts, medical writers, and biostatisticians by the hour, straight from inside ProWriter. Browse the bench, pick an open time, choose a session length, and pay securely through the platform.
- Specialists across regulatory, clinical, CMC, and biostatistics
- Applications reviewed before an expert is listed
- Hourly rate listed up front
- Sessions and bookings managed inside the workspace
bench
Secure Messaging.
End-to-end encrypted. For your workspace.
Direct messages and channels for your team, end-to-end encrypted and built into the same workspace as your documents. Messages are encrypted on your device, so ProWriter can never read your chats.
- Channels and direct messages, end-to-end encrypted
- Encryption keys live on your device, not our servers
- Live typing, presence, and read receipts
- HIPAA-grade, 21 CFR Part 11 infrastructure
Electronic Notebook.
A daily journal for protocols, observations, and figures, organized into notebook books and dated entries. Capture the protocol, attach the evidence, and link an entry to the document section it supports.
- Notebook books with dated entries
- Attach figures, images, and data files (PDF, CSV, XLSX)
- Tags and custom fields on every entry
- Link entries directly to the documents they support
- HIPAA-grade, 21 CFR Part 11 infrastructure
14:22
09:48
11:05
Teams.
Roles. Workspaces. Seats.
Shared workspaces, role-based and document-based access, and member and project assignments. Built for the way regulatory and clinical teams actually work, where two writers, three reviewers, and one QA lead all need to see the same source of truth.
- Owner · Manager · Member · Associate roles
- Shared workspaces for documents and templates
- Pooled team plan with seats you can add as you grow
Auto Update.
Diff, then decide.
For when you've drafted a section and want to revise it without losing voice. Select a section, write a prompt, and see exactly what changes, removals struck in red, additions in green. Accept or reject the change, or revert an individual edit in the diff. The reference grounding stays attached through the rewrite.
- Side-by-side diff for every prompt
- Accept or reject per section, with granular control
- Reference grounding carries through the edit
- Works inside any template
In this study, the participants were administered the investigational compound, which was given to them in a randomized fashion across visits.Participants received the compound in randomized order across visits. The primary endpoint that was being measured throughout the study(measured at week 12) was symptomatic improvement.[3]
Data Analysis &
Visualization.
More than fifty statistical tests on your data, with assumption checks, descriptives, and a plain-language interpretation, exported to CSV or XLSX, alongside publication-ready figures.
t-tests, ANOVA, regression, and survival analysis like log-rank and Cox proportional hazards, run on your data with assumptions checked and the result interpreted, plus charts to visualize it.
Multiple products. One Workflow. One Subscription.
Individual from $24.99/mo · Teams $39.99/seat.