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Dashboard Protocols8 Amendments7 Tasks Library Audit log

Before we draft anything

Let's design the study before we write the protocol.

Identity

What should we call this study?

What is the investigational drug?

What condition is this study for?

Which therapeutic area?

What phase is this study?

On-treatment period, in weeks?

Objective

What decision does this study need to support?

Cardinal checks the numbers against each other before drafting.Generate Protocol

Protocols / MERQ-RA-202

Merqutinib In Rheumatoid Arthritis Draft

OverviewSections15ScheduleDocumentsDesign studioRisk analysis13IntelligenceReviewHistory

1 Synopsis

2 Abbreviations

3 Background And Rationale

4 Objectives And Endpoints

5 Study Design

6 Study Population

7 Study Interventions

8 Assessments

9 Statistical Considerations

10 Safety Monitoring

5. STUDY DESIGN

5.1 Overall Design

This is a Phase 2b, randomised, double-blind, placebo-controlled, parallel-group study of Merqutinib in adults with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate.

5.2 Number Of Participants

Approximately ~~320~~ 360 participants will be randomised 1:1 across the treatment arms. Tracked change

5.3 Duration

The on-treatment period is 24 weeks, followed by a 4-week safety follow-up.

sections generated

WordPDF

Grounded in your IBEvery clinical claim traced to its source.

ICH M11 structureEditable, with tracked changes.

Protocols / MERQ-RA-202

OverviewSections15ScheduleDocumentsDesign studioRisk analysis13IntelligenceReviewHistory

Schedule Of AssessmentsClick a cell to toggle a procedure at a visit

Procedure	V0D-28	V1W0	V2W4	V3W8	V4W12	V5W16	V6W20	V7W24	V8W28
Primary Endpoint
ACR20 Response
DAS28-CRP
Adverse Events
Vital Signs
Concomitant Medication
Complete Blood Count
Blood Chemistry

Audit Log

Removed Vital Signs at V8Medical Writer, just now

Added ACR20 Response at V1Medical Writer, just now

Regenerated ScheduleCardinal, version 3, today

Sample size 320 to 360Medical Writer, version 2

Accepted flag: Operational BurdenBiostatistician, version 2

Generated 15 sectionsCardinal, version 1

Protocols / MERQ-RA-202

OverviewSections15ScheduleDocumentsDesign studioRisk analysis13IntelligenceReviewHistory

AMENDMENT RISK SCORE

72%High

2PENDING

3ACCEPTED

1DISPUTED

Operational Burden75%[67–83%]Source

High amendment risk linked to "Assessment burden in the first 12 weeks"

Advisory: Consolidate low-yield assessments or enable remote visits.

Enrollment Feasibility69%[61–77%]Source

Elevated amendment risk linked to "Sample size (n=360)"

Advisory: Pressure-test enrollment against realistic site activation timelines.

Endpoint Precedent68%[60–76%]Source

Elevated amendment risk linked to "ACR20 as primary endpoint"

Advisory: Confirm regulatory precedent in this indication before lock.

All flags are advisory. Cardinal never finalizes a clinical or statistical decision.

Protocols / MERQ-RA-202

OverviewSections15ScheduleDocumentsDesign studioRisk analysis13IntelligenceReviewHistory

Enrollment BenchmarkerCaution

Based on 16 completed or terminated trials from ClinicalTrials.gov

264Median n

12325th pct

34675th pct

360Your target

≤ 2526–5051–100101–200201–500> 500

Your target of 360 is above the median (264) for similar trials. Achievable, but check site feasibility.

Trial Survival RateOn track

16 comparable trials analyzed

15Completed

1Terminated

0Stopped

Patient Competition RadarOn track

Currently recruiting trials, same indication

0 active trials

Design StandardsOn track

16 similar trials analyzed

100% randomized. Yours: parallel group.

Protocols / MERQ-RA-202

Merqutinib In Rheumatoid Arthritis In review

8. STUDY ASSESSMENTS AND PROCEDURES

Study assessments will be performed at the visits specified in the Schedule Of Assessments. Participants attend nine scheduled visits, with up to eight procedures at each.

Efficacy is assessed by ACR20, ACR50 and ACR70 response, DAS28-CRP and DAS28-ESR at each scheduled visit from Week 4 to Week 24.

Safety assessments include adverse event reporting, vital signs, concomitant medication review and laboratory evaluations.

Laboratory evaluations comprise complete blood count and blood chemistry at each visit from Week 0 to Week 24.

Ask Cardinal

Why is the schedule flagged?

Section 8Schedule Of AssessmentsRisk flag: 75%

What is the primary endpoint?Which sections still have TBD items?Summarise the eligibility criteria

Ask about this protocol

Product screens shown with example data.

76%: of trials need a protocol amendment
45%: of those amendments are avoidable
$535K: median cost of one Phase 3 amendment
587K: real trials behind every Cardinal check

Amendment figures: Tufts Center for the Study of Drug Development.

Same protocol. Nothing left unchecked.

See the same page before and with Cardinal.

MERQ-RA-202 ProtocolAmendment Risk 72%With Cardinal

5.2 Number Of Participants

Approximately 360 participants will be randomised 1:1.

75th PercentileAbove the median of 264 in matched trials.

4.1 Primary Endpoint

The primary endpoint is ACR20 response at Week 12.

Weak PrecedentElevated amendment risk for this endpoint.

9.1 Sample Size

A total of 320 participants is planned.

ContradictionSection 5.2 says 360.

8.1 Schedule

Up to eight procedures at each of nine visits.

High BurdenConsider consolidating assessments.

BeforeRisk UnknownMERQ-RA-202 Protocol

5.2 Number Of Participants

Approximately 360 participants will be randomised 1:1.

Not CheckedNo evidence behind this number.

4.1 Primary Endpoint

The primary endpoint is ACR20 response at Week 12.

Not CheckedNo evidence behind this number.

9.1 Sample Size

A total of 320 participants is planned.

Not CheckedNo evidence behind this number.

8.1 Schedule

Up to eight procedures at each of nine visits.

Not CheckedNo evidence behind this number.

Six reviewers. Before the real one.

Cardinal rehearses the review, so the first hard question is never a surprise.

Write the protocol once.

Cardinal carries the same facts into five more documents.

MERQ-RA-202 ProtocolICH M11

Phase: 2b
Sample Size: 360
Treatment: 24 weeks
Primary Endpoint: ACR20

SAPStatistical Analysis Plan

N = 360, randomised 1:1

ICFInformed Consent Form

24 weeks on treatment

SynopsisProtocol Synopsis

Phase 2b, N = 360

EDC SpecEDC Specification

ACR20 at each visit

AmendmentProtocol Amendment

320 to 360, tracked

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Indication

Phase

Target Enrollment (N)

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Cardinal Design CheckAwaiting parameters

Enrollment Feasibility —

P10P50 (median)P90

Also in the full checkEligibility BurdenEndpoint PrecedentAmendment Risk

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15 sections drafted from your IB
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