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
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Mar 18 | eCliniqua | SINGAPORE—Launched yesterday, the Pan-Asian Clinical Research Association (PACRA) aims to promote clinical research training and continuing professional development for clinical researchers across Asia. more Mar 18 | News Brief | ACM Global Central Laboratory has appointed a general manager of Asia Pacific, reflecting an increased focus on building ACM Global's partner labs in the region. more Mar 15 | eCliniqua | Pharmaceutical companies are beginning to embrace meaningful development of “companion diagnostics” in response to both the realities of applied genomics and the market disruption posed by personalized medicine. more 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. more Mar 15 | Expert Commentary | The aim of integration of technologies is certainly the sharing of common datato ensure that all systems have the most up to date information, data don’t need to be re-keyed, and discrepancies are reconciled between applications. more Mar 8 | News Brief | Acurian has announced that for all of the trials it supported in 2009, 54% of the patient referrals it generated came from online sources, including large health networks and ubiquitous social media platforms like Facebook and MySpace. more eCliniqua | As of this year, Eli Lilly and Company is converting to a new operating model designed to streamline drug development and better “capture the value” of a record-setting number of new medicines in its pipeline. The enablers include a flexible project management approach, routine use of advanced analytics and adaptive trial designs, and a focus on tailored therapies, says Tom Verhoeven, PhD, senior vice president and co-leader of the Development Center of Excellence. more eCliniqua | A two-year-old question could get answered this year when the Clinical Trials Transformation Initiative (CTTI) publishes a position paper on how best to improve trial monitoring. “The document will be the stance of the public-private partnership’s thinking on the matter that could lead to new FDA monitoring guidance, says Mark Behm, compliance advice and assurance regional director at AstraZeneca and member of a CTTI monitoring work stream. more Mar 1 | Business Week & IBJ | Eli Lilly and Covance plan to add a biotech element to their 10-year research agreement that started in 2008. Covance will begin early-stage testing of biotech drugs for Eli Lilly at a new biotech facility in Greenfield, Indiana. more
 | eClinical Visions - Clinical Trial Management: Enabling Operational Efficiency 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
|  | Remote Data Capture – Acquisition and Analysis 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
|  | Technology Video Report: A Day in the Life with Remote Data Capture (Next-Gen EDC) 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.
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Predict or Perish! Shaping the Practices of Clinical Trials
 Sponsored 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.
Indispensible technologies
driving discovery,
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Reports evaluating issues in pharmaceutical technology, business, and therapeutic markets
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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.
Bio-IT Weekly Update
eCliniqua
Pharma Services News
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.
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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