Your agentic edge in clinical development

Bring evidence, reasoning, and action together so your team can make better decisions, faster.

Book a demo → See how it works

One prompt sets the workflow in motion

RecordDesignReadinessWorkflowsHistory
New trial designDraft
+
Ready

Wired into
the stack you
already run

ARX-247 / Type 2 Diabetes Draft
Design
Study design
Randomized, double-blind, parallel group
Comparator
Metformin + placebo
Endpoints
Primary endpoint
adjudicated MACE as a safety endpoint
Primary timeframe
52 weeks
Primary unit
MACE events
Population
Sample size
300 participants
Inclusion criteria
No items yet. Add one below.
+ Add item✓ Save
Exclusion criteria
No items yet. Add one below.
+ Add item✓ Save
Operations
Treatment duration (weeks)
52 weeks
Regions
US, EU
Process
History
Design created3m ago, by You v0, current
Open full log ›
TeamOpen team ›
LPYouClinical Development LeadOwner
JSJess SmithBiostatisticsMember
MAMarcus AdeyemiRegulatory affairsMember
MHMariam HaddadClinical operationsMember
MCMaya Chenteammate@your-org.com Add member
MCMaya ChenMedical reviewerInvite sent

Every proposed change stays in one shared record

Your SOPs and standards guide every step

Bring every function into the workflow when it matters

Agents do the research and bring you the evidence

Trace every insight to its supporting sources

Turn the work into a decision-ready view

ARX-247 / Type 2 DiabetesDesign
LP

How does this compare to similar trials?

Checked 23 sources

Your design is more complex than 19 of the 22 closest comparators.34 It scores 52 against a median of 41.5 The 52-week window and the MACE follow-up account for most of the gap.68

Evidence Artifact

Sources23 cited in this answer

Comparable trials22

1

GLP-1 agonist, early phase

Phase 1N=154 wk

2

Incretin, cognitive impairment

Phase 3N=42076 wk

3

Weekly GLP-1 agonist, dosing

Phase 2bN=28812 wk

4

Dual GIP/GLP-1 add-on

Phase 2bN=40224 wk

5

Oral GLP-1, dose-finding

Phase 2bN=26012 wk

6

SGLT2 inhibitor add-on

Phase 2bN=31212 wk

7

Glucokinase activator

Phase 2N=19012 wk

8

GLP-1/glucagon co-agonist

Phase 2bN=34626 wk

9

Weekly basal insulin

Phase 2N=20516 wk

10

Amylin analogue combination

Phase 2N=17620 wk

11

Oral small-molecule GLP-1

Phase 2bN=41126 wk

12

Triple agonist, dose-finding

Phase 2N=28124 wk

13

GPR40 agonist

Phase 2N=22412 wk

14

Fixed-ratio combination

Phase 2bN=33024 wk

15

Glucagon receptor antagonist

Phase 2N=16612 wk

16

FGF21 analogue, fatty liver

Phase 2N=19816 wk

17

Insulin sensitiser add-on

Phase 2N=21412 wk

18

SGLT1/2 inhibitor, renal

Phase 2bN=30226 wk

19

Weekly DPP-4 inhibitor

Phase 2N=24012 wk

20

PPAR agonist, dose-response

Phase 2N=18812 wk

21

DPP-4 inhibitor, older adults

Phase 2N=15212 wk

22

11β-HSD1 inhibitor add-on

Phase 2N=17412 wk

Reference documents1

23

Background therapy labelling

Clinical studies section

Complexity vs. comparable trials

ARX-24752

Median41

Rank4of 23

Median 41ARX-2472065

By domain

  • Study design58
  • Operations66
  • Regulatory54
  • Site burden38
  • Patient burden44

Closest comparators

SourcenReadoutScore
328812w35
440224w47
526012w33
ARX-24730052w52

Readiness checks run on every change

∧∧ARX-247 / Type 2 DiabetesRecordDesignReadinessHistory
ARX-247In designEndocrinology

ARX-247 in Type 2 Diabetes

Predicted amendments6
Operational2 Endpoint2 Safety1 Eligibility1
How to fix them
Complexity score52/100
Operational execution66 Study design58 Regulatory oversight54 Patient burden44 Site burden38
How to reduce
Regulatory gaps26
FDA13 EMA10 PMDA1 NMPA2
Review gaps

Explore decisions in parallel without losing context

Carry every approved change forward with clear ownership

From predicted amendments

LPDr. Lena ParkTrial design

↑Is 52 weeks out of step with comparable trials?

12 of 22 comparators read out by week 12. The tail is carrying MACE, not the primary.

Treatment duration52 weeks→12 weeks

From complexity score

MAMarcus AdeyemiRegulatory affairs

↑What renal floor applies to metformin add-on trials?

Metformin is contraindicated below eGFR 30.

Exclusion criteriaNot set→eGFR ≥ 30

From regulatory gaps

JSJess SmithBiostatistics

↑Is MACE powered as a primary at n=300?

No. Too few events at this sample size. It belongs one level down.

MACE endpointPrimary→Key secondary

History
LPTreatment duration52 weeks→12 weeks14:02
MAExclusion criteriaNot set→eGFR ≥ 3014:19
JSMACE endpointPrimary→Key secondary14:41

Nothing moves forward without the right sign-off

Sign-off In Design
  • LP Trial design
  • MA Regulatory
  • JS Biostatistics
  • MH Clinical ops
  • MC Medical review

Turn your expertise into agents that work continuously

∧∧ARX-247 / Type 2 DiabetesRecordDesignReadinessWorkflows

New agent

Describe the reviewer. It reads every draft from then on.

Role

Cardiac safety reviewer

What it looks for, and on whose behalf.

Rulebook

PDFSOP-0142.pdf DOCDiabetes TA guidance.docx XLSLessons learned 2024.xlsx + Add source

Scope

Objectives Endpoints Schedule of assessments Safety
Route findings toSafety & PV ▾
Cancel Create agent

Agentic workflows from strategy to execution

ARX-247 / Workspace Study design v2.1 updated 2d ago
Review changes
Integrations

1.1 Synopsis

A Phase 2b, randomized 1:1, double-blind study of ARX-247 added to metformin in type 2 diabetes.

  1. Treatment for 12 weeks, with HbA1c change from baseline as the primary readout at week 12. 5
  2. eGFR of at least 30 at screening. 23
  3. MACE is collected as a key secondaryco-primary endpoint. 14
  4. About 300 participants across sites in the US and EU. 9