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The document is intended as a practical guide to assist clinical research site personnel in: Understanding and complying with regulations when participating in clinical research; Selecting or upgrading an EHR system to hold data which could potentially become source data to support regulations applicable to drug or medical device clinical trials or development activities; Identifying best practices in implementing and maintaining an EHR system, especially if it may hold data that could become source for clinical trials; and Clearly differentiating system-supported requirements from requirements that must be met through site processes. Howells, Senior Vice President, Product Development, Omni Comm Most clinical research applications are now outsourced, but we still need to share data between them.

Conventional integration strategies via batch loading no longer work, because the applications are in physically separate data centers.

Craig Lipset, Head, Clinical Innovation, Pfizer Worldwide Research & Development The time, cost, and complexity of clinical trials today is largely unsustainable -- the future of clinical trials is dependent upon innovation.

Mobile, health information technology, and telemedicine are just some of the key tools to enable clinical innovation.

A Medical Data Portal Surfacing Multi-Source Content and Visualizations Catherine Celingant, Senior Director, Medical Systems Innovative Technologies, Millennium: The Takeda Oncology Company To enhance drug development efficiency, Millennium’s Medical Informatics team and R&D stakeholders delivered a portal with multi-source content that is able to provide clinicians with advanced visualization capabilities.

It will also describe the challenges and benefits of the program 6 years from its initiation. H., President, Anolinx LLC Secondary use of healthcare data as real world evidence has become a forefront for clinical research.

The perspective is that of an academic medical center, so DF/HCC’s EDC experience both as a site and sponsor will be highlighted. This presentation will describe approaches to effectively leverage rich sources of electronic healthcare data for a variety of drug development activities.

D., Head, GPRD, Medicines & Healthcare Products Regulatory Agency Separate silos of CT and EHR data are not in the best interest of patients. Such a system enables many types of clinical trials.

Interactive Question and Answer Session with Speakers Coffee Break in the Exhibit Hall Chairperson’s Remarks Adrian Hsing, Senior Director, Clinical Operations, Elan Pharmaceuticals EDC has brought tremendous benefits for clinical trials: improved quality, shortened timeline and ultimately lower cost.

522 comments

  1. Electronic Data Capture in clinical trials– interface. source document. necessity of validating all computerized systems used in regulated environments.

  2. Such electronic source data. This guidance finalizes the draft guidance for industry entitled Computerized Systems Used in Clinical Trials, dated September 2004.

  3. It is a practical source. FDA's acceptance of data from clinical trials for regulatory decision-making purposes. or the method of electronic data collection

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