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        • R-009-001 US Sagimet ICON 20250113
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R-009-001 US Sagimet ICON 20250113

  • Contract sign date: YYYY MM DD (YYYY MM DD)
  • Deal id: 29460765043

Project details​

  • Customer name: Sagimet Biosciences Inc.
  • Project ID: 29460765043
  • Project name: US Sagimet ICON Alopecia Clinical Trial
  • Phase: 3
  • Sites number: 340
  • Subjects: 3260
  • Assessments: aprox 13,870 assessments
  • Participation duration in months: 36 months

Study timeline​

General Study Setup timeline​

To achieve the goals, the parties agree on the following timeline.

Detailed Study setup timeline​

To achieve the goals, the parties agree on the following timeline.

Training sessions​

The following table outlines the scheduled and to-be-determined (TBD) group training sessions for different regions. It provides a clear breakdown of the training sessions by location.

Training Sessions Breakdown​

RegionGroup Trainings numberStatus
United States/Canada (US/CA)12 group trainingsScheduled
Europe (EU)12 group trainingsTBD
Australia/New Zealand (AU/NZ)4 group trainingsTBD
South Korea (SK)4 group trainingsTBD
Mexico (MX)4 group trainingsTBD
Total36 group trainings

Training sessions schedule time​

Training sessions schedule time table​

PST (Pacific Standard Time), EST (Eastern Standard Time),CST (Central Standard Time) and CET (Central European Time)

DateRegionSite local timeLegit.Health local time (CET)
2025-02-18US/CA9:00 am US PST18:00 CET
2025-02-19US/CA8:00 am US EST14:00 CET
2025-02-19US/CA3:00 pm US CST22:00 CET
2025-02-20US/CA9:00 am US CST16:00 CET
2025-02-20US/CA3:00 pm US EST21:00 CET
2025-02-21US/CA11:00 am US EST17:00 CET
2025-02-24US/CA9:00 am US CST16:00 CET
2025-02-24US/CA3:00 pm US EST21:00 CET
2025-02-25US/CA9:00 am US PST18:00 CET
2025-02-26US/CA8:00 am US EST14:00 CET
2025-02-26US/CA3:00 pm US CST22:00 CET
2025-02-28US/CA11:00 am US EST17:00 CET
2025-03-01US/CATBDTBD
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TBDAU/NZTBDTBD
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TBDAU/NZTBDTBD
TBDAU/NZTBDTBD
TBDSKTBDTBD
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Time Zone Conversion Table​

CET (Central European Time)PST (Pacific Standard Time)EST (Eastern Standard Time)CST (Central Standard Time)More
3:00 PM CET (15:00)6:00 AM PST9:00 AM EST8:00 AM CSTTBD
4:00 PM CET (16:00)7:00 AM PST10:00 AM EST9:00 AM CSTTBD
5:00 PM CET (17:00)8:00 AM PST11:00 AM EST10:00 AM CSTTBD
6:00 PM CET (18:00)9:00 AM PST12:00 PM EST11:00 AM CSTTBD
7:00 PM CET (19:00)10:00 AM PST1:00 PM EST12:00 PM CSTTBD
8:00 PM CET (20:00)11:00 AM PST2:00 PM EST1:00 PM CSTTBD
9:00 PM CET (21:00)12:00 PM PST3:00 PM EST2:00 PM CSTTBD
10:00 PM CET (22:00)1:00 PM PST4:00 PM EST3:00 PM CSTTBD
11:00 PM CET (23:00)2:00 PM PST5:00 PM EST4:00 PM CSTTBD

Alerts workflow​

Information extracted from protocol: 7.3.8.Alopecia assessment​

Project tasks​

TaskDescriptionResponsible
Investigator's manual web platformDeveloping and providing access to the investigator's manualJD-013, JD-016
Set up of the platformSetting up the platformJD-007, JD-010
Account accessProviding access to relevant accountsJD-016, JD-007, JD-010
Certified training sessionsConducting certified training for team membersJD-016
Custom dashboard developmentDesigning and implementing a custom dashboard for the studyJD-014
Defining Data Transfer Agreement (DTA) specificationsCreating and defining the Data Transfer Agreement for sharing dataDeal Owner, JD-003, JD-013
TranslationsTranslating materials into the required custom languageJD-007, JD-010
Data TransferManaging and securing the transfer of study dataJD-016, JD-014, JD-003, JD-013
OversightOverseeing the study’s progress and ensuring complianceDeal Owner, JD-016
Technical and clinical supportProviding ongoing technical and clinical supportJD-016, JD-013, JD-003, JD-005, JD-007, JD-018, JD-004
Image anonymisationEnsuring anonymisation of images used in the studyJD-003, JD-005, JD-009
Customer SupportProviding assistance and answering questions from study participantsJD-016
Project CloseFinalizing the study, reviewing results, and preparing the final reportJD-016, JD-021

Note: All details are in the contract. The following roles will be present in all project stages and tasks: Deal Owner, JD-013, JD-003, JD-001.

Project leads​

TeamCodeLeader of
Legit.HealthJD-002, JD-008, JD-019Sales Manager, Business Development Manager, Sales Development Representative, Digital Health Manager
Legit.HealthJD-003, JD-013Design and Development Manager, Project Manager
Legit.HealthJD-018Clinical Research Manager
Legit.HealthJD-004Quality Manager & PRRC
Legit.HealthJD-007, JD-010Technology Manager, Software developer
Legit.HealthJD-005, JD-009Machine Learning Manager, Medical Data Scientist
Legit.HealthJD-014Data Analyst
Legit.HealthJD-016Customer Success Manager
Legit.HealthJD-021Account Manager
Company NameName SurnameProject Director
Company NameName SurnameProject lead

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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R-009-001 ES Licitación SESPA 20250101
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GP-010 Suppliers
  • Project details
  • Study timeline
  • General Study Setup timeline
  • Detailed Study setup timeline
  • Training sessions
    • Training Sessions Breakdown
    • Training sessions schedule time
    • Training sessions schedule time table
    • Time Zone Conversion Table
  • Alerts workflow
    • Information extracted from protocol: 7.3.8.Alopecia assessment
  • Project tasks
  • Project leads
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)