Protocol writing for clinical teams,
with structure built in
For teams who write protocols as a shared document, not a Word pile
Protocol writing is collaborative, regulated in tone, and version-sensitive. The failure mode is familiar: five drafts in an inbox, a sponsor redline nobody can reconcile, and no reliable answer to which version is current. Protowrit is for sponsors, CROs, and writing teams that need section-level ownership, review and approval by department, and a way for sponsors to comment without email carrying the workflow.
It is not an eTMF and not an eCTD publishing suite. Layouts and paper formats are configurable for regulated clinical documentation. Submission packaging sits outside this product.
What Protowrit actually covers
Protocol authoring
Protocol master records with study metadata, sponsor or CRO, phase, periods, and investigators. Nested HTML sections carrying sequence codes, titles, mandatory flags, and synopsis blocks. Writing instructions per section sequence guide authors inside the form. A reference library extracts source text into the editor from PDF, DOCX, DOC, ODT, XLSX, and TXT, and find-and-replace runs across protocol fields.
Templates and the generate wizard
Reusable protocol templates seed sections on create. A guided wizard collects study, product, population, and dosing inputs and builds the protocol from the selected template.
AI-assisted drafting
Optional Gemini-based generation fills template section contents from the wizard's study data in a single pass, and can generate Informed Consent content from the protocol. This is drafting acceleration. Review, approval, and sponsor lock stay with people.
Role-based review and approval
Per-section workflow: draft, waiting for review, waiting for approval, approved or rejected. Review and approval departments, manager and section-edit rights, and user and manager groups. Protocol status rolls up from its sections rather than being set by hand.
Sponsor portal collaboration
Portal users read the full protocol, leave text-selection comments and replies, track review progress, and navigate by section. Finalizing comments locks the protocol against new ones while replies stay open.
Versioning and Word round-trip
Revising a protocol archives the prior version, bumps the version, copies sections and comments, and keeps supersedes links between them. Upload the DOCX sent to the sponsor and the sponsor's response, and import Word comments into a revised protocol.
Export and Informed Consent
QWeb PDF with confidential headers, footers, and page rules, plus programmatic DOCX with table of contents and section content. ICD section masters and templates generate ICF documents from the protocol as DOCX or PDF. Layouts are configurable for regulatory-style clinical documents.
Audit and session controls
Field-level audit logs on protocol and section writes, HTML field history, password confirmation on sensitive saves, and idle-session auto-logout. Writing progress and comment-resolution dashboards sit over the top.
The protocol, its reviews, and its versions in one place
The value of Protowrit is that the protocol, its reviews, its sponsor comments, and its version history sit in one place. There is always a clear answer to which draft is current, who has signed off, and what the sponsor asked for, without reconstructing it from an inbox.
Writers, departments, and sponsors work off the same document, and the contacts, approvals, and export all run from it. When a protocol is revised, the prior version and the trail behind it are kept, so nothing about the decision history is lost.
Is Protowrit eCTD compliant?
We make no eCTD claim. Protowrit produces configurable PDF and Word protocol and ICF outputs suitable for regulated clinical documentation. eCTD packaging and submission tooling are outside this product.
Does AI write the whole protocol unsupervised?
No. AI drafting is optional and fills template sections from structured study inputs. Humans own review, approval, and sponsor lock. Treat it as acceleration, not a substitute for scientific or regulatory judgment.
Can sponsors comment without a backend login?
Yes. Sponsors and sponsor contacts use the portal review experience, with comments, replies, progress tracking, and optional lock after final comments.
Who is it for if we are not a CRO?
Any clinical research writing team that needs structured protocol authoring with department review and sponsor collaboration. If what you need is a generic document management system, this is heavier than the job.
See Protowrit against your own workflow
Book a demo and we will walk a protocol template, a review path, and the sponsor comment flow through how your team actually writes. Not a slide deck of screenshots.