Every language.
EC-ready.
Clinical Trial Content Governance
Consent, assent, translations and videos — version-controlled in one master record, reviewed by role and EC-ready.
Vera Content gives clinical trials one governed record for every patient-facing word — reviewed, version-controlled and traceable to EC approval.
“I need the links of the scripts, all in one mail.”
— a leading European paediatric academic centre
This is the pain Vera Content™ exists to eliminate. The product is one email with assets — reviewed, version-controlled, EC-ready.
Trial content is approved once, then drifts — and inspectors notice.
Amendment lag
The protocol is amended and the ICF is updated — but sites keep enrolling on the old version and the re-consent window slips. No dashboard flags it in real time.
TMF–site mismatch
The Trial Master File shows v4.0 approved. At the site, v3.0 is still in circulation. That version gap is exactly what an FDA or EMA inspector flags.
Re-consent you can't prove
No clean link between EC approval date, ICF version and each subject's signature — so consent validity is hard to evidence when it matters most.
Global template chaos
Across countries, translations, local compensation clauses and privacy language drift out of the master — and audit defensibility erodes with them.
They're not buying videos.
They're buying the process.
The product is one email with assets.
The moat is not software. It's a repeatable clinical-governance operating model — credentialed reviewers, paediatric quality processes, EC-ready packages.
The QC process
R1 linguistic, R2 medical, mandatory final QC. Defined gates. Documented escalation.
The reviewer network
Credentialed CVs — paediatrician, CTM, GCP inspector — disclosable to ethics.
The submission package
Every governed asset, age-banded, lineage-tracked, EC-ready by design.
One master record. Every dependent asset linked to it.
A change to the master flows to every translation, subtitle, video and EC package — automatically and traceably.
Future-proof your paediatric trial communication.
- Not sure which version was approved for EC submission
- Duplicated review effort across every language
- Email chaos and version drift
- No clear audit trail for ethics committees
- Assets scattered across drives, emails and folders
- Clear version control and approval tracking
- Review once, propagate across languages
- Structured workflows with role-based access
- Append-only audit trail, EC-ready
- One platform for all consent and assent materials
From protocol to EC-ready package.
Discovery
We review your protocol, communication objectives, target age groups, languages and EC submission requirements — mapping asset needs, review pathways and responsibilities before work begins.
Build from approved foundations
Reuse approved consent, assent, storyboard and educational libraries aligned to your study — cutting duplication across age groups, languages and studies.
Configure governance
Set reviewer roles, approval workflows, language adaptations, youth review and EC submission pathways to match your organisation.
Track, package & submit
Monitor review, hold version alignment across all languages and age bands, and generate EC-ready bundles with full approval traceability and audit history.
We delivered the work manually first. The platform formalises what we already know how to do.
Leading European paediatric academic hospital programme
EC-reviewed communication programme delivered. Methodology validated under real ethics-committee review.
Multiple research communication programmes delivered
Across academic, sponsor and patient-engagement settings — methodology refined through repeated delivery before being formalised in the platform.
Peer-reviewed in Pharmaceutical Engineering (ISPE GAMP, 2025)
Burgstaller et al., Reimagining Informed Consent: AI Avatars in the Era of Complex Clinical Trials. Methodology field-validated in a US clinical study.
The pressure on paediatric communication is rising. The infrastructure isn't.
Regulators are tightening
EU CTR 536/2014 has intensified scrutiny of multilingual ICF and assent quality across Member States. FDA, EMA and national regulators now expect paediatric assent to reflect age-appropriate comprehension — not adult-language translation.
Youth involvement is now expected
Ethics committees and youth advisory groups (GenerationR, eYPAGnet, KIDS Anti-Cancer) are increasingly part of sponsor-facing review. But their input has no governed system of record — it lives in workshops, spreadsheets and email.
No incumbent governance layer
eConsent platforms deliver consent; LSPs translate; eTMF systems store. None govern the multilingual, age-banded content lifecycle behind paediatric communication. The infrastructure layer is empty.
Land with implementation. Expand to platform subscription.
Take production from Bionabu or bring your own. The platform is the constant. Pricing scales with assets, languages and governance scope — figures shown are representative, not fixed package prices.
Build your package. See the saving.
Configure your scope
How many languages?
Short videos (≤40s)
Long videos (≤3.5min)
5 languages × 19 assets ≈ 21 min finished video
Estimated saving
Build your package
Tick what you want from Bionabu. Untick anything you'll handle in-house.
Part of the Bionabu system
Vera Content is the middle layer. Upstream, PrepStoriesAI prepares the patient; downstream, Vera Deviate controls what slips through. Same standard, end to end.
Book a walkthrough.
We'll map one of your studies to Vera Content and tell you whether it fits. If it doesn't, we'll tell you that too.
Book a walkthrough →