Life Sciences & Research
Protocol, Trial & Regulatory Document Operations
Research runs on documents that must be exact: protocols, consent forms, study reports, submissions and the correspondence that accompanies them. The work of keeping them consistent with each other, and with the regulation that governs them, is slow and unforgiving. Scalata's agentic AI platform reads across the whole document estate and shows where it disagrees with itself.
How it works
The four-step journey
The same shape every time: name what is going wrong, put the documents somewhere they can be read, let people ask questions of them, and then hand the repeating parts to agents that do not need asking.
- 01
Confronting Document Volume & Version Drift
A study generates protocols, amendments, consent forms, reports and submissions, each version of which must agree with the others. Reconciling them is manual, and drift is usually found late — during a submission or an inspection.
- 02
Building a Unified Research Document Core
The study estate is ingested with its version history intact, so every artefact is readable alongside the ones it depends on rather than as an isolated file.
- 03
Activating Intelligent Consistency & Evidence Analytics
Claims in a report can be traced to the data that supports them, and inconsistencies between a protocol, its amendments and the documents derived from them are surfaced as they appear.
- 04
Full Automation with Proactive Research AI Agents
Drafts are assembled from the approved source material, inconsistencies are raised while they are cheap to fix, and agents keep the submission checklist current as the estate changes.
Strategic Outcome
Documents stop disagreeing with each other quietly. Inconsistencies surface while a study is running rather than during a submission, and every claim can be shown back to the data underneath it — which is the difference between being ready for an inspection and preparing for one.
Who Scalata serves
- Medical writers assembling study reports and submissions
- Regulatory affairs teams tracking submission requirements
- Clinical operations teams managing protocol amendments
- Quality teams preparing for audit and inspection
- Study managers watching document status across sites
- Data managers linking claims to underlying evidence
What you can generate
- Cross-document consistency and drift reports
- Claim-to-source traceability matrices
- Draft study documents assembled from approved sources
- Submission checklists with current status
- Inspection readiness summaries
Turn weeks of expert work into minutes
See how Scalata fits your team, your data, and your controls.