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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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Kay O. Christopher
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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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You are welcome to link to articles on our website. Contact Allison Proffitt for details.
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| IN THIS ISSUE |
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Oracle Clinical Development Analytics Could be Game Changing. |
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clinicalRSVP Detects and Stops Attempted Dual Enrollers |
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Implementing Core Clinical Trial Technologies |
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Pen-Based Site Visit Reporting Solutions |
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TRIAL MANAGEMENT
Oracle Clinical Development Analytics Could be Game Changing
By Deb Borfiz
 A clinical trial intelligence tool newly released by business software giant Oracle appears destined to boost R&D productivity and reshape interactions between industry sponsors and their multitude of partners aiding drug development.
For years now, the key players-pharmaceutical companies, clinical research organizations (CROs), and investigative sites-have navigated their way through clinical studies as special-interest camps with "misaligned objectives," says Nick Giannasi, vice president of life sciences product strategy in Oracle's health sciences division. Oracle Clinical Development Analytics, launched in November, is designed to clarify what the targets are and bring visibility to how well they're being met in real time. Read more.
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PATIENT ENROLLMENT
clinicalRSVP Detects and Stops Attempted
Dual Enrollers
By Ann Neuer
 One of the more intractable problems in clinical research is identifying which subjects are attempting to enroll in more than one study at once or have failed to meet the required waiting period between studies. Independent Data Integrator (IDI), a Florida-based provider of IT solutions, is addressing the longstanding challenge of identifying these so-called dual enrollers head on. With its Clinical Research Subject Verification Program, or clinicalRSVP, a Web-based subject registry, dual enrollers can be easily spotted and stopped from entering a study.
ClinicalRSVP uses fingerprint biometric identification technology and a handful of other pieces of identifying information, such as subject's initials, date of birth, sex, and last four digits of the social security or tax-ID number. The subject is fingerprinted at the time of screening, after which the fingerprint is scanned, a code is generated and then stored in a database along with the other identifiers. Then, the database is searched for the potential subject and his or her most recent dose history. Read more.
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EXPERT COMMENTARY
Implementing Core Clinical Trial Technologies
By Bill Byrom
In the clinical space today, more technology solutions are being used, and investigational sites often employ multiple solutions within a single study to perform their responsibilities. Solutions include clinical trials management systems (CTMS), electronic data capture (EDC) systems, electronic patient reported outcomes (ePRO) solutions, randomization and trial supply management (RTSM) solutions (typically deployed using IVR/IWR technology), medical imaging technologies, central ECG management and reporting solutions, adverse event and safety systems to name but a few. Read more.
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EXPERT COMMENTARY
Pen-Based Site Visit Reporting Solutions
By Gautham Pandiyan
The preferred workflow of most health care professionals continues to be pen-based, not keyboard-based. Several technologies have been developed recently that address this issue of EDC in a clinician-friendly manner with electronic pen-on-paper systems, including the Digital Pen and Tablet PC. Read more.
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Most-Read Story from Previous Issue
Study Finds 'Operational Gap' in Clinical Trial Portfolio Management
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CDER 2009 New Drug Approval Performance Summary
From the U.S. Regulatory Reporter
Without the typical flurry of new drug approvals late in the year, CDER finished 2009 with 19 new molecular entity (NME) approvals, down from 21 in 2008. The 19 NME approvals last year represent CDER's second-highest total in a five-year stretch that has seen comparatively low levels of new drug approval output. From 2005 to 2009, CDER has approved 92 NMEs, compared to 120 during the previous five-year period (2000 - 2004).
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 
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
- 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
- The Post -Approval Summit, May 11-12, 2010, Boston,MA
- Beyond Sequencing Strategies for Success, June 22, 2010, San Francisco, CA
- 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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| eCliniqua Reader Survey |
eCliniqua is conducting a brief survey to gather information on the eCliniqua eNewsletter and its companion web site, eCliniqua.com. Access and complete the survey and your name will be entered into a drawing to receive a $10 Starbucks gift card. Thank you in advance for your participation.
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eCTD 2010
March 10, 2010 | Philadelphia |
The inaugural eCTD conference-- hosted by CHI, Bio-IT World, and eCliniqua-- will cover how to achieve efficiency & compliance in electronic formats.
A sampling of featured presentations:
- How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submissions
- Global Submission Management from Concept to Realization
- Taking eCTDs off the Critical Path to Drug Development
- Electronic Signatures & Regulatory Processes, What Agencies are Saying
View conference details and register today. Mention key code ECL & save $300 off your registration! |
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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.
Submission details and entry form are available here. If you have questions, write to aproffitt@healthtech.com
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| FEATURED CONTENT |
Curing Life Sciences Data Management  Challenges with Scalable Storage
High performance storage systems are a given to meet today's life sciences R&D computational challenges. But with the explosive growth in data produced by next-gen lab equipment, scalability and long-term data management issues must also be addressed. Read this paper to learn:
Why new lab equipment will impact R&D workflows
How to avoid the hidden costs of long-term data management
What approach you should take to accommodate today's data while having the flexibility to scale to meet future demands. Download Whitepaper (Sponsored by: Panasas)
 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 )
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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