Real World EDC Benefits

Post on 09-Jun-2015

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Transcript of Real World EDC Benefits

Late-phase study names

Observational, Evidence Based Medicine

Outcomes, REMS

Phase IV, Post Approval

Post Marketing, Real World Studies

Real World EDCUnique focus on late-phase studies

The Clinical Site

• Organise the workflow

• Minimise time inputs

• Quality: right data first time

• Shorten the study timelines

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Monitoring

• Achieve site

recruitment targets

• Track source data

validation, fulfilling

compliance

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Project Manager

• Fast set-up

• Local language

• Rapid access to

information

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Medical Director

• Fast track real world

outcomes

• Mitigate risk

• Drive lower costs

• Get actionable data-driven

insights

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Marketing Director

• Support product launch

• Speed outcome and maximise impact

• Prove product value

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eCRF Build

• Do I have the skills,

time and tools to build

the CRF?

• Self-build or CTEP

build options

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Data Manager

• Minimal rule and query

processing

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