Catch the consistency gaps, missing estimands, and unsupported claims that trigger information requests — before the document leaves your desk. Calibrated to a regulatory reviewer's eye and cross-referenced against ICH and regional frameworks.
Intercurrent-event handling (treatment discontinuation, rescue medication) is not defined for the primary endpoint — a predictable information-request trigger.
MAJORConsistency
Synopsis and statistical section define discontinuation differently
The synopsis treats discontinuations as non-responders; the analysis assumes data missing at random. These are not reconcilable.
MAJORRegulatory
EU CTR transparency requirement not addressed
Lay-summary and results-posting obligations under EU CTR 536/2014 are not referenced for the EU arm of the program.
MINORClaim support
Secondary-endpoint phrasing implies a confirmatory claim
Wording in the discussion implies confirmatory benefit on a secondary endpoint without pre-specified multiplicity control.
The review work that eats your week
Inconsistencies between the synopsis, body, and statistical sections that reviewers flag as deficiencies
Endpoints and estimands that don't align with ICH E9(R1) or the stated objectives
Claims in briefing documents that outrun the evidence and invite an information request
Cross-referencing FDA 21 CFR, ICH E6(R2), and EU CTR 536/2014 by hand under deadline
What TrialScope checks for you
Consistency sweep
Reconciles objectives, endpoints, estimands, and conclusions across the whole document and flags conflicts between sections.
Regulatory cross-reference
Tags content against the applicable framework — FDA 21 CFR, ICH E6(R2)/E9(R1), EU CTR 536/2014 — for the region you configure.
Claim support
Checks that statements in briefing and labeling content are supported by the cited results and flags overclaiming.
Submission-readiness verdict
A clear go / revise verdict with findings ranked by regulatory impact, not just a wall of comments.
SEE IT ON YOUR OWN DOCUMENT
Upload a protocol, CSR, manuscript, or briefing document and get an audit calibrated to regulatory affairs — findings, severities, and a verdict in under 90 seconds. Free to use.
Frequently asked questions
Can TrialScope review regulatory submission documents?
Yes. TrialScope audits protocols, briefing documents, clinical study reports, and submission-module content, cross-referencing ICH and the regional framework you select, and returns findings ranked by regulatory impact. It is decision-support — not a substitute for your regulatory judgment or a regulatory filing service.
Which regulatory frameworks does it cover?
You configure the region; TrialScope cross-references FDA 21 CFR and ICH E6(R2)/E9(R1) for the US, EMA and EU CTR 536/2014 for the EU, plus MHRA, PMDA, NMPA, Health Canada, and TGA for other regions, defaulting to the most stringent applicable standard for multi-regional work.
How is it calibrated for regulatory affairs?
Audits run through a regulatory-affairs persona, and corrections from verified regulatory professionals refine how the system reasons for that role over time — so findings are prioritized the way a regulatory reviewer would prioritize them.