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By BIO-IT World
 THE TIMING OF THIS REPORT couldn't be better. For nearly six years, complying with 21 CFR Part 11 — the federal rules governing the use of electronic records and signatures for FDA submissions, as well as in manufacturing and production — has been problematic, to put it mildly, for any drug or biotech organization. Confusion has reigned inside the FDA and in the marketplace as to what's included in Part 11 and how the regulations will be enforced. Meanwhile, the cost of buying new compliant software and/or retrofitting systems is projected to run into millions of dollars per company by 2006. The result: the exact opposite of what the FDA wanted. Rather than encouraging companies to adopt new technology, for example, to submit New Drug Applications electronically, Part 11 has hobbled the introduction and full use of such technology. This is what economists call "the law of unintended consequences," and fortunately the FDA has recognized it. Our lead story, by Barbara DePompa Reimers, includes an interview with Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. Woodcock candidly explains the need for, and the steps toward, regulatory reform. Two attorneys from Hale & Dorr's FDA Group, Mark Heller and Stephanie Philbin, provide expert deconstruction of this reform effort and offer advice on avoiding citations amid the agency's shifting enforcement priorities. Deborah Ausman profiles the Baylor College of Medicine's successful Part 11 compliance with software it developed for managing paperless clinical trials. And for an industry perspective, Paul Bleicher, founder of Phase Forward, dissects the challenges of collecting clinical data electronically with no original paper records — the regulatory equivalent of working without a net. The regulatory climate is changing, apparently for the better, and we hope this report will help you better assess your compliance strategy. Tony Strattner
Special Projects Editor
ILLUSTRATION BY ALEX NABAUM
|  Next-Generation Technologies Revolutionizing Oncology and Diagnostics
underwritten by Definiens
This “Briefing On” collection of Bio-IT World features, commentaries and analysis, presents some of the latest thinking on high-throughput technologies that are being applied to the fields of research and drug discovery, with particular emphasis on oncology, diagnostics and imaging technologies. Download now at no charge compliments of the underwriting sponsor, Definiens. Download This Free Paper
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This Bio•IT World Briefing On “Next-Generation Sequencing,” underwritten by GenomeQuest, Inc.,
presents a selection of feature stories, interviews,commentaries, conference reports, and editorials on the emergence, opportunities, and challenges posed by high-throughput sequencing. Covered in this collection: the launch of new platforms from Applied Biosystems and Helicos; new applications of nextgen sequencing; the rise of personal genomics; and informatics solutions to vexing problem of managing the vast volumes of next-gen data. Download now
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GenoLogics
Enabling Translational Research Informatics
Learn about the challenges facing life sciences research labs to manage their translational research data:
- The trends for organizations to adopt informatics solutions for translational research.
- The unique requirements with managing complex data and workflow.
- What labs should consider when reviewing informatics solutions for translational research.
- Which life sciences research organizations are successfully adopting an informatics solution.
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