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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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Peddicord: New Privacy Concerns with 'HIPAA 2' |
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Informed Consent Errors a Global Phenomenon |
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StudyOptimizer 4: Leveraging History to Improve Enrollment |
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News Briefs |
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PATIENT PRIVACY
Peddicord: New Privacy Concerns with 'HIPAA 2'
By Deb Borfitz
 A new set of federal privacy and security requirements, introduced by legislation promoting the adoption of electronic health records (EHRs), "may make the investigator-CRO interface more complicated for some time," says Doug Peddicord, executive director of the Association of Clinical Research Organizations. The new data use restrictions "go well beyond the privacy rules established by HIPAA [Health Insurance Portability and Accountability Act] in 1996 and constitute a de facto transition to HIPAA 2."
It took physicians and hospitals several years to adjust to "HIPAA 1," Peddicord notes, and nerves are unlikely to calm any faster on this go-round-especially for worry-prone academic organizations. "Criminal penalties can be enforced against individuals, not just covered entities [CEs] and their employees." In cases of willful neglect, civil monetary penalties have shot up from $100 per violation with an annual maximum of $25,000 to as much as $50,000 per violation with a $1.5 million annual cap. Read more.
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CLINICAL TRIAL MANAGEMENT
Informed Consent Errors a Global Phenomenon
By Deb Borfitz
The informed consent process for clinical trials is intended to be relatively constant site to site and nation to nation, in accordance with the ethical principles set forth by the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice (ICH-GCP E6) Guideline. But as regulatory agencies have repeatedly acknowledged, the process in actual practice suffers from "chronic deficiencies," says Chris Brouillard-Pierce, director of Toronto-based consultancy CQA Solutions.
The deficits are related to content as well as the manner and timing of consenting, says Brouillard-Pierce, who has conducted GCP audits for trial-sponsoring pharmaceutical and biotechnology companies in Canada, the U.S., the U.K., and Eastern Europe. Read more.
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SOFTWARE
StudyOptimizer 4: Leveraging History to Improve Enrollment
By Deb Borfitz
 After a "light release" in the fall of 2008, DecisionView finally has version 4 of its StudyOptimizer clinical trial software "market-ready"-this time, with a fourth top-ten biopharmaceutical company in the queue for the upgrade. The reward for the wait is a new foresight capability, allowing trial-sponsoring companies to leverage information about their completed trials to more accurately plan for their future patient recruitment efforts, says CEO Jim Scullion.
The company's flagship product now includes advanced historical analysis and templates capabilities, as well as more predictive analytics functionality, says Scullion. Coupled with StudyOptimizer's existing features, including rear views of enrollment patterns and metrics plus real-time enrollment status of active trials, the application offers clinical trial managers a "comprehensive 360 degree view" of their organization's patient recruitment performance. Read more.
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Most-Read Story from Previous Issue
Strong Uptake for Site-Specific CTMS
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FDA Releases New Investigator Responsibility Guidance
From the U.S. Regulatory Reporter, September 2009 issue
CDER and CBER have released a new guidance that uses stronger and more specific language to detail clinical investigator and sponsor responsibilities in overseeing a clinical investigation. The guidance includes new FDA warnings regarding investigator and sponsor responsibilities when site management organizations (SMO) are used, and when SMO staff fill the study coordinator or site/nursing staff roles.
To read the full article, subscribe to the U.S. Regulatory Reporter. |
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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
Approaches to Reducing Phase II Attrition 
Author: Allan B. Haberman, Ph.D.
There is a high rate of attrition in the drug development process that severely limits the numbers of high quality novel drug candidates. To overcome this limitation, the Pharma industry needs to develop strategies to reduce attrition during Phase II. Read more .
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FEATURED EVENTS
- Molecular Med Tri-Conference Short Courses
- Adopting R&D Informatics Systems
- 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 |
Bio-IT World's 2010 Best Practices Awards Program
Entry forms are now available for Bio-IT World's 2010 Best Practices Awards program. The program is intended to spotlight companies whose use of innovative technologies is making a positive difference in biomedical R&D and drug discovery and development.
Bio-IT World is also making available a free compendium of Best Practice entries from 2009 to help ensure the lessons learned are widely spread. The compendium can be downloaded here .
Full details of the entry process and the entry form are available by clicking here . The deadline is January 18, 2010.
2009 Best Practice 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 |
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 ) Beyond EDC…Optimizing ROI by  Streamlining Clinical Research Processes
Although EDC brings tremendous efficiencies to clinical data collection, numerous repetitive clinical development activities exist beyond its scope which are in need of more efficient processes. As these activities move from paper-based to electronic, the transition can be eased through the use of intelligent PDF forms. Using XML capabilities, intelligent forms can follow workflows while leveraging established point solutions such as EDC, CTMS and IV/IWRS to optimize return on investment. Download Whitepaper (Sponsored by: Adobe)
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)
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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