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Macro at Organon Ritte Dijkstra

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Introduction Organon. Founded in 1923. Global company present in ... Training of Organon personell by InferMed. Meeting to review all OC details with InferMed ... – PowerPoint PPT presentation

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Title: Macro at Organon Ritte Dijkstra


1
Macro at OrganonRiëtte Dijkstra
2
Contents
  • Introduction Organon
  • Selection process
  • Organization of implementation
  • Preparations trials

3
Introduction Organon
  • Founded in 1923
  • Global company present in 60 countries
  • Operates from shared head offices in Oss, The
    Netherlands and Roseland, New Jersey, USA
  • Number of employees worldwide 15,000
  • Products sold in over 100 countries

4
Introduction Organon
  • Therapeutic areas
  • Contraception
  • Menopause and Andropause
  • Mental health
  • Fertility
  • Anesthesia

5
A selection of Organon products
6
Selection process
  • 354 Business and User Requirements
  • Resulting from pilot trials
  • 17 high level criteria
  • 3 major criteria
  • EDC product on market
  • On/offline product
  • OC interface

7
Organization of implementation
  • Representatives Global EDC Implementation team
  • Oss (Europe) and Roseland (US)
  • Departments involved
  • Data Quality Control
  • Project Data Management
  • CDM Systems Programming
  • Clinical Data Systems Programming
  • Monitoring Organization
  • Clinical Development Department
  • Data Capture Systems

8
Preparations trials
  • FSH-CTP two IVF trials
  • Trial 1
  • 1400 subjects, sites in Europe and USA
  • Clinical start in August
  • RDE
  • Trial 2
  • 300 subjects, sites in Europe and Australia
  • Clinical start in July
  • RDE

9
Preparations trials
  • Development of Macro database
  • Training of Organon personell by InferMed
  • Meeting to review all OC details with InferMed
  • Project planning and action steps
  • Training CRAs (30)
  • First training emphasis on site preparations
    and decision laptop needed
  • Second training emphasis on monitoring process
    and in-depth Macro knowledge CRAs will train the
    investigators

10

Preparations trials
  • Documentation
  • Process description
  • Training manuals CRAs/Investigators
  • General CTT manual
  • Database test document
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