01 / PRODUCT · CTD

Know when your trial documents disagree

CTD identifies which clinical-trial documents may be stale, which remain consistent, and why.

Assess the impact of a protocol amendment across consent forms, country versions, translations, and site materials—or let CTD monitor your public trial documents and alert you when a potential discrepancy appears.

SOURCE · AMENDED PROTOCOL
Protocol v4.0
AMENDMENT 3
§5.2 DOSING · CHANGED
“1500 mg per administration”
CTD TRACE
12 DEPENDENCIES
DOWNSTREAM · 12 DOCUMENTS 10 CONSISTENT · 2 REVIEW
Informed consent form
DE · GERMAN · v3.1
REVIEW
Participant information sheet
ES · SPANISH · v2.4
CHECK
Country protocol variant
FR · FRENCH · v4.0
CONSISTENT
Site instruction pack
JP · JAPANESE · v1.8
CONSISTENT
Pharmacy manual
GLOBAL · ENGLISH · v4.0
CONSISTENT
+ 7 MORE DOCUMENTS ASSESSED
EVIDENCE · CONSENT FORM (DE) v3.1 · §4 DOSING
AWAITING REVIEWER
SOURCE · PROTOCOL v4.0 §5.2
“1500 mg per administration”
DOWNSTREAM · CONSENT FORM DE v3.1
“1500 g per administration”
REVIEWER DECISION REQUIRED · NOTHING IS AUTO-APPROVED
Confirm discrepancy Mark expected
One amendment. Every affected document traced.
02 / PROBLEM · BLAST RADIUS

One change can affect hundreds of documents

A protocol amendment rarely stays within the protocol.

The change may need to reach participant consent forms, translated materials, country-specific versions, site documents, and other approved content. Today, experienced teams often have to find those dependencies through manual review, spreadsheets, and institutional knowledge.

That process is slow, difficult to reproduce, and vulnerable to one outdated sentence surviving in one document.

CTD provides the change-control layer between the source of a change and every document that depends on it.

03 / REVIEW SURFACE

Review what matters—not everything again

CTD calculates the downstream impact of a change and gives reviewers a focused, evidence-backed worklist.

FOR EVERY DOCUMENT, CTD SHOWS
What may be stale
What appears unaffected
The source and downstream values
The exact quotations supporting the finding
The dependency or rule that produced it
The document, country, language, and version involved

Your team remains in control of every decision. CTD makes the review surface smaller, clearer, and easier to defend.

04 / PRODUCT PROOF · FINDING

What a finding looks like

Every reported difference arrives with the quotations, the versions, and the reviewer decision still open.

FINDING 004 · TRIAL NCT0000000 · PUBLIC RECORD
HIGH PRIORITY
Potential dose discrepancy
PROTOCOL
“1500 mg per administration”
PARTICIPANT DOCUMENT
“1500 g per administration”
COUNTRY: DE LANGUAGE: GERMAN SOURCE VERIFIED
STATUS: AWAITING REVIEWER
Assign reviewer Open evidence

CTD does not send a generic notification that two files are different. Each finding carries the exact quotations from both sources, the country and language involved, and a link to the public source.

Anonymised example based on a public trial record. Presented as a review signal, not a determination of noncompliance.
05 / MONITORING

Continuous monitoring of your public trial record

Important discrepancies do not only appear during a planned amendment workflow.

A new consent form may be published in one country. A translated version may retain an earlier value. A document may be replaced without the corresponding protocol or participant material being updated. These changes can remain difficult to see when documents are spread across registries, countries, languages, and versions.

We keep watching after the assessment is complete.
PUBLIC SOURCES · CONTINUOUS
DAY 0
Baseline established
CTD reads the available public documents for the trial and records the current values, versions, countries, and languages.
DAY 42
New document published
A revised consent form appears in one country while the protocol on record stays at its previous version.
DAY 42 · +6H
CTD detects a changed value
The participant-facing dosing value no longer agrees with the current public protocol. The finding is categorised by seriousness.
DAY 42 · +6H
Alert sent with exact quotations
Both passages, the source links, the country and language, and the previous CTD assessment travel with the alert.
DAY 43
Reviewer confirms or resolves it
A named reviewer decides whether the difference is expected, country-specific, already controlled internally, or requires corrective action.

CTD can monitor the supported public sources for your trials and alert your team when:

A new or revised document is published
A public protocol or consent version changes
A participant-facing value disagrees with the current public protocol
Country or language versions describe different values
A change appears to have reached some documents but not others
A potentially serious discrepancy requires prompt review
Previously verified evidence disappears or changes

This gives clinical operations, regulatory operations, and quality teams an independent early-warning system for the public trial record.

Every alert includes the evidence

CTD does not send a generic notification that two files are different.

Each alert can include:

The trial and affected document
The new document or version detected
The seriousness category
The potentially inconsistent values
Exact quotations from both sources
Country and language
A link to the public source
The previous CTD assessment
The reason the issue was flagged

Your team can quickly determine whether the difference is expected, country-specific, already controlled internally, or requires corrective action.

06 / ONBOARDING

Start without an internal integration

Public-document monitoring provides a simple way to begin using CTD.

You tell us which trials to monitor. CTD builds an initial baseline from the available public documents, identifies existing questions, and then checks new or revised publications against that baseline.

No access to internal systems is required for the initial service.

If a potential discrepancy is found, your team receives an evidence-backed alert for review. Internal documents can later be added to provide earlier detection and a more complete change-control record.

07 / PRIORITISATION

Prioritise the discrepancies with the greatest potential impact

Not every inconsistency deserves the same urgency.

CTD helps teams prioritise differences involving:

Medication doses and dosing intervals
Administered exposure
Clinical and eligibility thresholds
Safety risks and adverse events
Pregnancy and contraception instructions
Participant procedures and burden
Consent rights, privacy, and data retention
Study design and document-version integrity

Routine administrative differences do not compete with potentially important participant-facing issues for attention.

08 / MECHANISM

From change to review-ready evidence

1 DETECT
CTD identifies a protocol amendment, document revision, new publication, or inconsistency in the monitored record.
2 TRACE
The affected facts are mapped to the consent forms, translations, country variants, and other documents that depend on them.
3 CHECK
Every finding is tested against exact source and downstream quotations. Unsupported assertions are rejected.
4 PRIORITISE
Reviewers receive a focused list of actionable questions, ordered by potential seriousness.
5 RECORD
Findings, corrections, reviewer decisions, provenance, and versions form a reproducible change-control history.
Deterministic from trace to report. Nothing is automatically approved.
09 / TRUST

Deterministic where trust matters

CTD is not a black-box model making approval decisions.

Its repeatable comparison, evidence checking, dependency tracing, and reporting are deterministic: the same evidence produces the same result.

AI can assist with initial document reading or genuinely ambiguous passages inside an approved environment, but it cannot silently approve, overwrite, or bypass the evidence. Only a named human reviewer can approve a result.

10 / COMPATIBILITY

Works with the documents you already have

CTD sits above your existing clinical and regulatory systems.

There is no requirement to replace your authoring platform or migrate approved documents before CTD can help.

IT CAN WORK WITH
Protocols and amendments
Informed consent forms
Country and site variants
Translations
Tracked-change Word files
PDFs and scanned documents
Safety and operational materials
Documents published through supported public sources
11 / MULTINATIONAL

Built for multinational trials

A change can reach six language versions and still leave the seventh behind.

CTD treats every country and language version as an independently controlled document. It compares the underlying facts—not only identical wording—so it can assess values expressed through translation, paraphrase, different units, or numbers written as words.

This creates a systematic way to check whether the same clinical meaning reached every required version.

DE · GERMAN FR · FRENCH ES · SPANISH IT · ITALIAN PL · POLISH JP · JAPANESE BR · PORTUGUESE ! REVIEW
12 / ENGAGEMENT

Two ways to start

Monitor your public trials

We establish a baseline for the selected trials, monitor supported public sources for new and revised documents, and alert your team to potential discrepancies.

YOU RECEIVE
An initial public-document health check
Ongoing document and version monitoring
Seriousness-ranked alerts
Exact evidence for every finding
A record of changes over time
Periodic portfolio-level reporting

Assess a completed amendment

Give us one recently amended Phase II or III trial, including the previous and amended protocol and the documents your team reviewed.

We independently produce an amendment impact report before seeing your completed assessment. We then compare the results with what your team actually changed.

YOU RECEIVE
A seriousness-ranked findings register
Evidence for every reported discrepancy
A map of affected documents and passages
Findings caught, missed, and unnecessarily flagged
Review-volume and workflow measurements
An assessment of document lineage and traceability
Recommendations based on your own trial

Nothing is generated or approved during the assessment.

13 / MATURITY PATH

From public monitoring to internal change control

Public monitoring provides an independent external control. Connecting CTD to internal documents moves detection earlier—before potentially inconsistent material is published.

The service can grow with the organisation:

STAGE 1
Monitor the public trial record
STAGE 2
Assess a recent amendment
STAGE 3
Check document packages before release
STAGE 4
Integrate with internal document workflows
STAGE 5
Apply reusable controls across the portfolio

Document dependencies, sponsor templates, approved relationships, and reviewer decisions become controlled assets that improve future assessments.

Change control for the clinical documents you already have

Know what changed.
Know what it affects.
Know when the public record disagrees.
Keep the evidence.

Public-document findings are review signals, not determinations of regulatory noncompliance. Public sources may be incomplete or appear after an internal change has already been controlled.