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An Electronic Data Capture (EDC) system is a programmed system intended for the compilation of clinical data in electronic arrangement for use mainly in human clinical trials. EDC replaces the conventional paper-based data gathering methodology to reorganize data assortment and accelerate the time to promote for drugs and medical devices. EDC resolutions are broadly adopted by pharmaceutical companies and clinical research organizations.
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Scope and Importance:
EDC can increase the data accuracy and decrease the time to collect data for studies of drugs and medical devices Typically, EDC systems provide:
EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research,but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance.
Clinical research data—patient data collected during the investigation of a new drug or medical device is collected by physicians, nurses, and research study coordinators in medical settings (offices, hospitals, universities) throughout the world. Historically, this information was collected on paper forms which were then sent to the research sponsor (e.g.,a pharmaceutical company) for data entry into a database and subsequent statistical analysis environment. However, this process had a number of shortcomings:data are copied multiple times, which produces errors
To address these and other concerns, RDE systems were invented so that physicians, nurses, and study coordinators could enter the data directly at the medical setting. By moving data entry out of the sponsor site and into the clinic or other facility, a number of benefits could be derived:
These early RDE systems used "thick client" software—software installed locally on a laptop computer's hardware—to collect the patient data. The system could then use a modem connection over an analog phone line to periodically transmit the data back to the sponsor, and to collect questions from the sponsor that the medical staff would need to answer.
The report provides an overview of clinical development phases, the regulatory issues involved, and the factors influencing clinical trial costs. An overview is provided of new technologies that will be affecting the clinical trial process in the near future. Major product pipelines are provided by physiological system and company. New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period. Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014.
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This page was last updated on 11th Sep, 2015
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