February 8, 2010
| eCliniqua



Industry Trends

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Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials

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



Clinical News & Analysis


Feb 8 | Canadian Business | Phase Forward's stock prices fell last week, and the company registered four quarter losses of $68,000 compared with last year's fourth quarter gains of $2.7 million.

  more

Feb 3 | eCliniqua | 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.

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Feb 3 | eCliniqua | 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.

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Jan 27 | RFP Connect | OmniComm Systems has announced its TrialMaster EDC is now connected to Microsoft HealthVault.

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Jan 22 | News Brief | Quintiles and invivodata, inc., have announced a collaboration agreement  to transform the way Patient Reported Outcomes (PRO) are used in clinical research to speed drug development.

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Jan 19 | Expert Commentary | “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.

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Jan 19 | eCliniqua | 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.   more

Jan 19 | eCliniqua | 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.

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Jan 15 | News Brief | Practice Fusion has announced the launch of its free e-prescribing system for physicians. Doctors now have the ability to electronically transmit prescriptions to pharmacies at no cost.

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Jan 15 | News Brief | Almirall, an international pharmaceutical company, has chosen Perceptive Informatics to provide core solutions in its eClinical Suite for several clinical trials in the respiratory therapeutic area.

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White Papers & Special Reports

Quantum
StorNext 4.0: Technical Product Brief
Sponsored by Quantum

 
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. In this Technical Brief you'll learn:

  • How a high-performing file system can accelerate your business
  • How to simplify your data management
  • How a tiered storage approach can save you money
SURETY-IP_WPx108
Protect Your Scientific Intellectual Property: Proof of Lab Informatics Data Authenticity is Your Best Legal Defense
Sponsored by Surety, LLC

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. Consider:

  • IP protection requirements in bio-pharma and other science-oriented industries can extend out 20, 30, 40 or more years
  • Most electronic lab management solutions include generic authenticity controls, so how "legally defensible" is yours?
  • Only standards-compliant, independent controls can future-proof your approach to long-term IP integrity protection and authenticity.
  • Learn more - get the free whitepaper now
BlueArc_WP_DataMigration.jpg
The Key to Life Sciences Data Management: Transparent Migration
Sponsored by BlueArc

Life sciences organizations face new data management challenges as the volume of research data grows and more data is kept online for longer times. Read this paper to learn about:

  • The benefits of transparent data migration (TDM)
  • How TDM technologies can simplify data management.
  • How using TDM can help increase storage utilization, improve computational workflow performance, and optimize the use of storage resources.


Life Science Webcasts & Podcasts

adobe_i3_btn_webinarNext-Generation Clinical Trial and Data Management Applications
Sponsored by Adobe

This webinar introduces i3Cube - a web-based, fully integrated, clinical trial and data management system built on Adobe’s LiveCycle® Enterprise Suite.  I3 cube provides end-to-end automation that delivers unprecedented visibility into information that sponsors need to accelerate the study process and complete trials efficiently. Viewers will learn more about:

  • Creating faster and more efficient trial processes
  • Reducing investigator burden 
  • Real-time sponsor transparency into study information
  • Enterprise solutions based on Adobe LiveCycle® ES utilizing cross-platform clients of Reader, Flash and AIR

    Download now.




Related Web Sites

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Bio-IT World
Indispensible technologies
driving discovery,
development, and
clinical trials 

Insight Pharma Reports
Reports evaluating issues in pharmaceutical technology, business, and therapeutic markets

Barnett Educational Services
Leaders in
quality training
resources

 

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eCliniqua is Sponsored by:

ERT Medidata
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Drug Development & Clinical Research Reference Guides

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New Drug Development 

New Drug Development:
A Regulatory Overview

An authoritative reference book that addresses the most cutting-edge developments redefining how new drugs are developed and regulated today.  New Drug Development is pharma/biotech’s “go-to” resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA’s drug development approval processes.  View book details here. 




Insight Pharma Reports

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Inflammatory Disorders: Therapies That Suppress or Balance the Immune Response
Author: Lucy J. Sannes, Ph.D., MBA
ipr_immu
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.


Job Openings

Employers -- Don't miss this opportunity to reach well-qualified life science candidates.


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