Macro at Organon Ritte Dijkstra

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Macro at OrganonRiëtte Dijkstra
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Contents

• Introduction Organon
• Selection process
• Organization of implementation
• Preparations trials

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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

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Introduction Organon

• Therapeutic areas
• Contraception
• Menopause and Andropause
• Mental health
• Fertility
• Anesthesia

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A selection of Organon products
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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

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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

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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

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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

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Preparations trials

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