Every Vertex template ships with section structure, production-grade Word formatting, and draftable example text. Tailored to sponsor branding on delivery. Designed to work together as one coherent suite.
Why example text matters. The hardest part of regulatory writing is the first draft. Writers stare at instructional placeholders such as "describe X here" and lose hours generating text that's already been written, in some form, a thousand times before. Vertex templates ship with concrete plug-and-play prose so writers refine and adapt instead of authoring from scratch.
And it isn't generic. Every line of example text is grounded in decades of regulatory medical writing experience: what survives FDA review, what triggers information requests, and what reviewers actually accept. The phrasing is what works in real submissions, not what reads cleanly in isolation.
The public Solutions page focuses on the three documents regulatory teams pull first: the Protocol, the Investigator's Brochure, and the Module 2.7 / 2.5 pairing where cross-document reuse pays off most. Each ships as a Word document with structure, formatting, automation tooling, and concrete example text in every major section.
Vertex protocol template covers all M11 sections from synopsis through full body. Example text is included throughout. Numbering and cross-references hold across amendments.
The IB tells investigators whether to enroll the first subject, and it signals to reviewers and IRBs whether a trial is safe to begin. Vertex's IB template ships with example text across all sections so writers spend their time refining judgments, not staring at instructional placeholders.
Module 2.7 is where writers most often misplace content across the four sub-summaries. Module 2.5 is the document FDA reviewers read first. Vertex pairs the two so 2.7.3 efficacy summaries and 2.7.4 integrated safety summaries link cleanly into the 2.5.4, 2.5.5, and 2.5.6 sections that depend on them. Benefit-risk language ships in current FDA-acceptable phrasing, neither over-claiming on efficacy nor under-stating safety signals. Tables and listings cross-reference into Module 5 source CSRs.
More on request. Vertex's full template library extends across the regulatory authoring stack: CSR, DSUR, FDA correspondence, patient safety narratives, pediatric study plans, and more. Available on request.
Full-length regulatory templates you can download and compare against any incumbent suite. Most vendors keep their templates behind a sales call. Vertex publishes them.
Full ICH M11-aligned protocol template with example text across all sections.
View the templateFull IB template, all seven sections, with example text and Reference Safety Information structure.
View the templateThe demo focuses on whichever document type matters to you: protocol, IB, CSR, or Module 2.