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Issue No. 5 |
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June 2009 |
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Industry News:
Medical Imaging Emerges in Clinical Trials: A 2007 Assessment
CenterWatch 2007
The FDA, in an effort to increase new drug approvals, has identified imaging as an important technology for assessing new therapeutics and accelerating drug development in the future.
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Events
We invite you to visit PAREXEL at these upcoming industry events. Events are a great way to get to know our experts, discuss your outsourcing challenges, and learn how PAREXEL’s global reach, technology and expertise can help your organization.
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| Cover Story:
Making the Right Imaging Choices for Clinical Trials |
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Scientific and technological advances across a broad range of therapeutic areas are fueling a rapid increase in the utilization of medical imaging throughout the clinical trial process. Many study sponsors now rely on advanced imaging modalities such as computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), and positron emission tomography (PET) for primary and surrogate endpoints to assess novel therapies at every stage of development: validating early-stage drug candidates; establishing safety and efficacy during pivotal trials; and supporting regulatory submissions.
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| Expert Profile: |
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Barbara E. Tardiff, M.D., M.B.A., Corporate Vice President, Data Sciences, PAREXEL International
Dr. Tardiff joined PAREXEL in 2007 with a unique background in medicine, information management, business administration, clinical research, and science. She is an expert in the integration, deployment, and evaluation of biomedical data, and has participated in a broad range of scientific and operational development activities.
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| Best Practices: Evaluating ePRO Tools for Clinical Trials |
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The migration from paper based questionnaires to electronic formats for the collection of patient reported outcomes (PROs) represents a significant advancement for improving the accuracy and timeliness of PRO data. There are two common forms of electronic PRO (ePRO) data collection: handheld electronic devices that patients use to enter their outcomes information; and interactive voice response (IVR) systems that utilize standard telephones to record patient data entries.
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