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| home > epc > spring 2003 > archiving edc data: further challenges for compliance |
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European Pharmaceutical Contractor
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The last 15 years has seen a gradual yet inexorable growth in the adoption of electronic data capture (EDC) by both pharmaceutical and medical device industries. Estimates vary on the uptake rates with some references suggesting a figure between four and 15 per cent on a global scale (1). Undoubtedly the increase in the enterprise-wide adoption of systems has cemented the commitment of the industry to such technology. To date, the focus of attention has very much been on front-end trial set-up activities such as edit check and screen design rather than planning for end-of-life archiving.
However as the regulatory framework is becoming established, company polices and procedures towards archiving need to be developed. It is clear that many companies are proving slow to prepare for the regulatory challenge, with an independent survey indicating that only 50 per cent of responders were aware of specific US rules on electronic records (2). This article will examine several of the key factors concerning the archiving of EDC data and it seems appropriate to commence by revisiting the use of paper records.
The Established Model
The archiving of paper records is a well-defined and established model. Any move to EDC needs to successfully challenge this approach. Paper itself is a robust medium if treated correctly and testament to this fact is the collection of 12th Century documents held by the UK Public Records Office, amongst others. However the maintenance of paper records is subject to various risk factors such as environmental conditions (that is temperature and humidity), fire, flood and pest damage.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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