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Industry Trends
Clinical Research Off-shoring
By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore. 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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Study Finds 'Operational Gap' in Clinical Trial Portfolio Management |
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Healogica to Exit Difficult Market for Online Trial Matchmakers |
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News Briefs |
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TRENDS
Study Finds 'Operational Gap' in Clinical Trial Portfolio Management
By Deb Borfitz
For most biopharmaceutical companies, the pressure to improve clinical trial portfolio management efficiency has arrived sooner than their operational readiness to meet the challenge. Corporate intolerance for budget variances above 5% of target is now commonplace. But widespread absence of project-level operational metrics has made it all but impossible to drive planned-to-actual spending into alignment. Read more.
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PATIENT RECRUITMENT
Healogica to Exit Difficult Market for Online Trial Matchmakers
By Deb Borfitz
It's an ostensibly sound idea: give the Internet-savvy masses a simple, high-speed search tool for navigating a comprehensive but cumbersome clinical trials listing website. But industry sponsors have deep reservations about the concept, effectively taking down at least two otherwise promising trial matchmaking services. Read more.
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Most-Read Story from Previous Issue
More Quintiles Work Going to 'Prime Sites'
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Advocacy Groups Optimistic on Expanded Access Programs, Despite Recent Blows
From the U.S. Regulatory Reporter
Despite consecutive defeats in both early 2008 and late 2009, patient advocacy groups hoping to convince or force federal authorities to liberalize patient access to experimental drugs in clinical trials remain optimistic about their chances going forward. Much of this optimism derives from what they see as a seismic shift in the FDA's view of access programs due to the change in the agency's leadership team.
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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eCTD 2010
March 10, 2010 | Philadelphia |
| Finding new submissions is time consuming and costly to both regulators and drug development organizations. Global regulatory agencies are committed to improving the approval process and the electronic Common Technical Document (eCTD) is seen as a practical solution. It has been mandated in some countries and, to date, over 30,000 eCTD sequences have been submitted to the FDA alone. This inaugural conference is intended to cover how to achieve efficiency and compliance in electronic submissions. For further conference details and a brochure, click here . |
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| BEST PRACTICES 2010 Deadline Extended |
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 |
StorNext 4.0: Technical Product Brief 
Proven in the world's most data intensive industries, Quantum StorNext is a scalable, high-performance file system which allows data sharing across Linux, Mac, Unix, and Windows operating systems and manages data in enterprise storage environments. Download Whitepaper (Sponsored by: Quantum )
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)
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)
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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