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Industry Trends
A Market Model for EDC in Clinical Trials
By Mark P. Mathieu
EDC vendors are positioned to benefit from the broad trend across the pharmaceutical industry to redesign the way drugs are discovered and tested. As clinical trials have grown in size, complexity, and geographic reach, the inefficiency of using multiple processes to collect data has been magnified. Read more.
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Contact the editors
Contributing Editor Deborah Borfitz covers development planning and protocol design; investigative site selection and management; and patient recruitment and retention.
Contributing Editor Ann Neuer covers project management, operations, and outsourcing, as well as data collection, data management, and electronic data capture. Ann has been writing in the clinical trials sector since 1995. |
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| IN THIS ISSUE |
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More Quintiles Work Going to 'Prime Sites' |
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PHT Scales for Global ePRO Business by Updating StudyWorks |
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The Reality of Medical Software Compliance |
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News Briefs |
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SITES
More Quintiles Work Going to 'Prime Sites'
By Deb Borfitz
 Quintiles has been quietly but diligently working with a few investigative sites on three continents-one each in the United Kingdom, United States, and South Africa-to improve the output of clinical research. These Prime Sites, as Quintiles has termed them, are focused on rooting out operational inefficiencies while creating the infrastructure necessary to expand into new therapeutic areas.
The initiative began more than two years ago at the University of London's Queen Mary College and expanded to Washington (DC) Hospital Center in 2008 and the University of Pretoria last July, says Adam Chasse, global head of Prime Sites at Quintiles. The sites are all large institutions with a sizeable patient population and high proportion of physicians potentially or actively engaged in clinical research. They also share Quintiles' vision about the role of clinical research within their respective organization. Read more.
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ePRO
PHT Scales for Global ePRO Business by Updating StudyWorks
By Ann Neuer
With the market for electronic patient report outcomes (ePRO) heating up, ePRO provider PHT Corporation is launching a significantly updated version of StudyWorks, its online portal. Sheila Rocchio, vice president of marketing, says that the portal's expanded capabilities are designed to accommodate the sector's growth, fueled by the December release of a final PRO guidance by the Food and Drug Administration (FDA). Several sections of the guidance are devoted to ePRO.
"We know that 25 percent of studies are now including PRO, and we believe that of those studies, approximately 25 percent are adopting ePRO. This is a global figure, and we are expecting that number to rise, especially with the final guidance now in place," Rocchio says.
To handle the anticipated upswing in the sector, the StudyWorks portal has come to market with several new features. The most significant is the inventory reports meant to reduce the challenge of tracking ePRO devices such as SitePad, which resides at the investigative site; and LogPad, which is distributed to study volunteers. Read more.
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EXPERT COMMENT
The Reality of Medical Software Compliance
By Kent Matthies
"It is estimated that 60% of the computer systems containing patient medical records currently in use within the United States are not in compliance with the industry standards for security, audit trails, and electronic signatures," states industry expert David Nettleton, FDA Compliance Specialist, of Computer System Validation.
With the Health Information Technology for Economic and Clinical Heath Act (HITECH Act) signed into law by President Obama last February, can health care organizations afford to be in that 60% group? The intent of the act is to use IT to improve health care quality and save money, while also strengthening privacy and security laws to protect the health information from misuse. The act provides both incentives for adopting meaningful electronic health records (EHRs) and penalties for not adopting EHRs. Furthermore, the HITECH Act now gives Health and Human Services (HHS) the ability to impose stiffer penalties for Health Insurance Portability and Accountability Act (HIPAA) violations. Read more.
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Most-Read Story from Previous Issue
Peddicord: New Privacy Concerns with 'HIPAA 2'
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An Analysis of NME Review Cycles to Approval to Mid-2009
From the U.S. Regulatory Reporter
A new U.S. Regulatory Reporter analysis of review cycles to approval for new molecular entities (NME) suggests that lower percentages of NMEs approved in 2009 may be gaining that approval in the first review cycle. This analysis comes amid reports of what has been, in terms of NME approvals, a highly active period for the FDA.
To read the full article, subscribe to the U.S. Regulatory Reporter or email customer.service@barnettinternational.com.
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SPONSORED LINKS
To have your product or service featured here, contact Lynn Cloonan for more information.
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Insight Pharma Reports 
Inflammatory Disorders: Therapies That Suppress or Balance the Immune Response Author: Lucy J. Sannes, Ph.D., MBA The human immune system can go awry, either attacking an individual's body or producing an exaggerated response to a foreign substance that is normally benign. In these situations, immunotherapies are needed to balance or suppress the unwarranted immune response. This report reviews the problems of insufficient efficacy, side effects, and adverse events associated with the small-molecule and biological drugs available today to treat these disorders. Read more . |
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FEATURED EVENTS
- Adopting R&D Informatics Systems
- Molecular Med Tri-Conference Short Courses
- Tufts Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation | Feb 8-12, 2010 | Boston
- Electronic Data in Clinical Trials, March 8-9, 2010, Philadelphia
- eCTD 2010 - One Day Forum, March 10, 2010, Philadelphia
- Summit for Clinical Ops Executives (SCOPE) - March 8-11, 2010 | Philadelphia
- Drug Development Latin America, March 10-11, 2010, Philadelphia
- Bio-IT World Conference & Expo • April 20-22, 2010, World Trade Center •Boston, MA
- Bio-IT World Web Symposia Series
- Barnett Educational Services
- Cambridge Healthtech Events
To have your event featured here, contact Lynn Cloonan for more information.
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BEST PRACTICES 2010
DEADLINE EXTENDED
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The deadline for the 2010 Bio-IT World Best Practices Awards Program has been extended to February 19, 2010.
Share Your organization's best practices with your peers. The Best Practices program recognizes individuals and teams for their novel and innovative uses of technology, business strategies, and solutions that improve some facet of the R&D / drug development / clinical trial process. Direct entries are encouraged as well as nominations from users and vendors.
"We're excited about this award and very honored to be a recipient of Best Practices from Bio-IT World." -Vanderbilt University; ActiveHealth Management
Submission details and entry form are available here . Deadline extended to February 19, 2010.
View the 2009 Best Practices Awards compendium today.
2010 Best Practices Categories
Basic Research & Biological Research Drug Discovery & Development Clinical Trials & Research Translational Medicine Personalized Medicine IT & Informatics Knowledge Management Health-IT Manufacturing & Bioprocessing
If you have questions, write to aproffitt@healthtech.com
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| FEATURED CONTENT |
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Protect Your Scientific Intellectual  Property: Proof of Lab Informatics Data Authenticity is Your Best Legal Defense
As a bio-technology or life sciences organization, your formulas, treatments and research and discoveries are the "lifeblood" of your business. But if you aren't protecting the integrity of your scientific data in your lab informatics systems, you risk losing IP ownership, revenue and consequently your business if you can't prove time-of-creation and data authenticity. Learn how you can implement simple, cost-effective and automated controls to protect your scientific intellectual property. Download Whitepaper (Sponsored by: Surety, LLC)
The Key to Life Sciences Data  Management: Transparent Migration Life sciences organizations face new data management challenges as the volume of research data grows and more data is kept online for longer times. Download Whitepaper (Sponsored by: BlueArc)
The Promise of Imaging Biomarkers  Imaging biomarkers are poised to join biochemical and molecular markers as drivers of drug development and disease management. They enable researchers and clinicians to see into the body without invasive procedures. They frequently provide earlier detection of disease and its progression than molecular markers. Researchers use them to see in detail how their candidate drugs behave such as determining the percentage of target receptors occupied by a drug or observing a drug's ability to cross the blood/brain barrier. They promise to save time and money too.
Download this white paper . (Sponsored by: Thomson Reuters )
To have your white paper featured here, contact Lynn Cloonan for more information
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| EXCLUSIVE WEBCAST |
Life Science Webcasts from Bio-IT World and Cambridge Healthtech Media Group
Moore's Law and the Future of Genome Sequencing
Guest: Jonathan Rothberg, Ph.D., Founder/CEO Ion Torrent Systems; Founder Curagen, 454 Life Sciences, Rain Dance
Editorial inteview conducted by Kevin Davies, Ph.D., Editor-in-Chief of Bio-IT World with Jonathan Rothberg reflecting on the past decade of his accomplishments and a glimpse at his new project, Ion Torrent Systems. Interview conducted at CHI's Exploring Next Generation Sequencing conference in September 2009. Download Now .
Oxford Nanopore's Third-Generation Sequencing Technology
Guest: John Milton, Ph.D., Vice President Research, Oxford Nanopore Technologies UK
Editorial interview conducted by Kevin Davies, Ph.D., Editor-in-Chief of Bio-IT World with John Milton that offers insights into Oxford Nanopore's potentially revolutionary new sequencing technology, which marries exonuclease cleavage of DNA and protein nanopores. Interview conducted at CHI's Exploring Next Generation Sequencing conference in September 2009. Download Now .
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