March 18, 2010
| eCliniqua > Trial Designs



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



Trial Design

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Rosenberg: Make Adaptive Clinical Trials More Agile

Mar 15 | eCliniqua | Companies that actively embrace adaptive methods will be tomorrow’s leaders in the biopharmaceutical industry, says Michael Rosenberg, president and CEO of Health Decisions, and author of the recently released book, The Agile Approach to Adaptive Research.

Oracle Clinical Development Analytics Could be a Game Changer

Feb 16 | eCliniqua | 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.

clinicalRSVP Detects and Stops Attempted Dual Enrollers

Feb 16 | eCliniqua | 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 problem with its Clinical Research Subject Verification Program, or clinicalRSVP.

Healogica to Exit Difficult Market for Online Trial Matchmakers

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.

Engaging E-Patients the BBK Way

July 20, 2009 | Clinical trial sponsors are largely unaware of the conflict that arises when dealing with the new, increasingly Internet savvy e-patient who is highly motivated, well educated, self-advocating, and self-informing, says Bonnie Brescia, of BBK Worldwide. “But the Internet is undermining that whole model.”

The Case for Making All Studies Operationally ‘Adaptive’

July 20, 2009 | The time- and cost-saving benefits of adaptive clinical trials (ACT) will be lost on companies unless they can generate an uninterrupted flow of information on which adaptations will be based, says Mike Ford, head of data management at Health Decisions.

Archimedes Turns Clinical Trial Models into Reality

June 22, 2009 | The Archimedes Model is a mathematical model that simulates human physiology (and the surrounding health care system) by creating virtual trial populations.

Genentech’s Clinical Trial Portal Tightens Bond with Investigative Sites

June 15, 2009 | Genentech's relationship with investigative sites—from initial protocol and feasibility surveys to study training, site activation, patient referral tracking, and safety letter distribution—is being wholly managed through a single-sign-on Clinical Trial Portal (CTP).

Wyeth’s Best Practices Winner Boosts Adaptive Clinical Trials

June 5, 2009 | Wyeth Research brought home this year’s Bio-IT World Best Practices Award in the Clinical Trial Design category for developing trial simulation software to streamline the process of designing and running adaptive clinical trials (ACTs).

Trial Planning: Drug Development's Unsung Hero

May 26, 2009 | Clinical trials are incredibly complex and costly endeavors—in fact, clinical research and development is arguably the most inefficient industrial activity in the world.

White Papers & Special Reports

oracle_clinical
eClinical Visions - Clinical Trial Management: Enabling Operational Efficiency
Sponsored by Oracle

Read how contributors from Genzyme, Duke Clinical Research Institute, Accenture, Oracle Health Sciences and others address some of the most pertinent challenges facing the biopharmaceutical industry including... Globalization of clinical trials driven by the need to reduce costs and recruit participants; greater outsourcing; escalating regulatory demands; increased trial complexity; and post-marketing studies. Download this paper to gain new insight into:

  • Recent progress made in addressing these challenges
  • Expert opinion on clinical trial management systems (CTMS) for improving trial efficiencies
  • How to cut trial costs and enhance the productivity of trial participants


oracle_RDC
Remote Data Capture – Acquisition and Analysis
Sponsored by Oracle

Today nearly half of all clinical trials are conducted electronically, and rising! Electronic Data Capture (EDC) technology provides industry-wide opportunities, along with challenges, that are being addressed. In this informative report industry experts and users from Pfizer, PPD, C3i and Oracle Health Sciences discuss the impact of EDC and its newest zero footprint; online iteration.  It can used anywhere, world-wide, where the Internet is available while placing greater onus on global trial support. The critical focus of this new technology is that it must support the work of the person at the heart of the clinical trial system– the investigator. Download this report to learn more about:

  • Trends and Issues in an Electronic Clinical Data Management World
  • The New Remote Data Capture Paradigm 
  • Improving and Monitoring Clinical Data Management in the eClinical Age
  • Optimizing and Supporting Remote Data Capture


oracle_video
Technology Video Report: A Day in the Life with Remote Data Capture (Next-Gen EDC)
Sponsored by Oracle
See why Oracle Remote Data Capture (RDC) Onsite is the next generation in electronic data capture with its user-friendly method to collect, clean, review, and verify clinical trial data. Providing unprecedented performance with real-time data capture, Oracle RDC Onsite simplifies source data verification. With a clear, consistent view of study data across all sites, the benefits include reduced monitoring time, decreased queries and discrepancies, and less time to database lock.



Life Science Webcasts & Podcasts

Predict or Perish! Shaping the Practices of Clinical Trials
Decisionview webinarSponsored by:  DecisionView

Predictive Analytics are a key differentiator in running your clinical trials successfully through 2010 and beyond. They will help you to optimize your patient enrollment, reduce your clinical operations costs and minimize your financial liability in the clinical supply chain. In this session, you will:
• Learn what predictive analytics are and what they are not
• Understand why you need predictive analytics to run your clinical trials, and
• Explore how predictive analytics will shape the future of clinical trials

Download Now. 

 



More Podcasts

Job Openings

The University of Washington Department of Genome Sciences is seeking a LINUX SYSTEMS ENGINEERING MANAGER to lead a team in a diverse scientific computing environment that includes multiple HPC systems, petascale storage, and custom application servers. Apply online at UW Hires for req number 61505.  http://www.washington.edu/admin/hr/jobs/



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