Specialist DTP
Clinical Trial Document DTP
ICFs, CRFs, protocols, investigator brochures and CSRs formatted source-matched and submission-ready, in every trial language.
Documents we format
- Informed consent forms (ICFs) — among the highest-risk documents in a trial
- Case report forms (CRFs) and patient diaries
- Protocols and amendments
- Investigator brochures
- Clinical study reports (CSRs)
Why formatting matters in trials
Trial documents move across many sites and languages, and the layout itself carries meaning — a mis-ordered table, a broken cross-reference or an overflowing translated section can cause rework, delay ethics approval, or in the case of patient-facing instruments, affect how a question is understood. B2K rebuilds each version source-matched and verifies it element by element against the source.
Built for audit
Every file passes a four-stage QA — processor build, QC against source, QA final check and project-manager sign-off — and is delivered with a documented trail that supports submission integrity. Confidentiality is protected by NDA, role-based access and an audit trail; ISO 9001 and ISO 27001 certification is in progress with TÜV SÜD.
Request a free sample or pilot
Send us a sample document (or tell us the languages, formats and deadline) and we will scope the work, run a short pilot, and commit to a date we can hold.
Request a sample →Frequently asked questions
What clinical trial documents do you format?
ICFs, CRFs and patient diaries, protocols and amendments, investigator brochures, and clinical study reports (CSRs).
Can you handle all trial languages?
Yes; we produce source-matched output across 40+ languages, including RTL and CJK scripts, for multi-country trials.
Do you keep each language version matching the approved source?
Yes; every version is rebuilt page for page to mirror the approved source and verified element by element against it.
How is confidentiality handled?
NDA before any file moves, role-based access limited to the named team, encrypted transfer and an audit trail; ISO 9001/27001 certification is in progress with TUV SUD.
Can you support submission timelines?
Yes; we run 24x6 and commit to an agreed date. As a benchmark we delivered 1,626 pages across 394 files in 3.5 days.