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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Aug 27 | eCliniqua Commentary | When researchers at the Cancer Vaccine Center (CVC) at Dana-Farber Cancer Institute (DFCI) began to study the cancer vaccine field, they gathered data from more than 645 vaccine trials, including cancer types, incidence, and survival rates, in order to identify relationships, trends and patterns. more Aug 23 | eCliniqua Commentary | The health care industry has long known the day would come when it would move to electronic medical records (EMRs), but has been slow to make this transition. Now those delays are over. The American Recovery and Reinvestment Act mandates adoption of EMRs by 2011, but providers needn’t take this as bad news. In fact, using EMRs across the health care spectrum will yield enormous benefits for providers and patients alike.
more Aug 16 | eCliniqua | Interest in orphan drug research has picked up noticeably in recent months, with both Pfizer and GSK opening up R&D units devoted to rare diseases earlier this year. The biggest impetus may well be expiring patents on more commonly used drugs and no potential blockbusters in the pipeline, theorizes Peter Saltonstall, president and CEO of the National Organization for Rare Disorders (NORD). Possibly, drugs developed for a rare disease can also be “leveraged” to treat more typical conditions. more Aug 16 | eCliniqua | In the past decade, clinical trial technology has undergone considerable evolution in its design, capability and deployment. From the early days of remote data capture, to full-suite clinical trial management solutions, this technologic evolution is redefining clinical research. Nevertheless, clinical research technology has suffered from significant resistance at the study site level, and this can be traced to a deficit in one basic element: user-centered design. more Aug 12 | News Brief | The Children's Hospital of Philadelphia has created a free app for the iPhone to help doctors record side effects in clinical trials. more Jul 27 | News Brief | ICON has announced the appointment of Jonathan M Fishbein, M.D. as Vice President and Global Head for the Infectious Disease Therapeutic Area Group at ICON Clinical Research. more Jul 27 | News Brief | Health Decisions has named Bryan Minihan as its new Chief Technology Officer. Minihan will strengthen Health Decisions’ proprietary HD360° technology platform more Jul 19 | eCliniqua | The 46th Annual Meeting of the Drug Information Association (DIA) held last month in Washington, D.C. sported a decidedly optimistic tone. A whole host of sessions and exhibits highlighted strategic partnerships among multiple stakeholders, the growing role of payers and comparative effectiveness research, electronic health records, continued globalization, and of course, the latest technological solutions. more Jun 23 | New York Times | The inspector general of the HHS released a report stating that 80% of the drugs approved for sale in 2008 had trials in foreign countries and 78% of all subjects that participated in clinical trials were enrolled at foreign sites. more Jun 21 | eCliniqua | Medidata announced two new products at the Drug Information Association (DIA) meeting this week in Washington, D.C.: an updated version of Grants Manager and Medidata Balance.
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 | eClinical Trial Technologies Revolutionizing Clinical Development Efficiency This Bio-IT World BriefingON report, sponsored by ClearTrial, presents a selection of recent stories from Bio•IT World and sister publication, eCliniqua, that illustrate how new technologies and approaches can have a profound impact on the management and execution of clinical trials.
|  | Remote Data Capture:Acquisition and Analysis See why Electronic Data Capture (EDC) is gaining traction in the pharmaceutical
clinical trials arena. Today approximately half of all clinical trials are conducted
electronically, and the figure is rapidly rising. Report includes contributions from
Oracle Health Sciences, Pfizer, PPD, and C3i. |  | The Role of Analytics in Transforming Healthcare Sharing many of the data challenges and opportunities faced by Healthcare, the Life Sciences industry remains focused on delivering new, innovative therapies and solutions to patients in a cost effective, timely and safe way. With spiraling R&D costs, new methods such as adaptive trials, and never ending need for deep pharmacovigilance, the Life Sciences companies that effectively use analytics to explore, monitor and optimize their business will rapidly become the new leaders. Oracle’s strategy—built upon Enterprise Health Analytics and Health Data Warehouse Foundation—provides a powerful, practical, and extensible approach to delivering the IT analytics infrastructure required to confront the worldwide healthcare challenge. |
Bio-IT World & CHI
Impact of the 1000 Genomes Project on the Next Wave of Pharmacogenomic Discovery
 Interview with M. Eileen Dolan, Ph.D., Professor, Medicine, University of Chicago and Speaker at Next-Generation Sequencing Data Management, September 27-29, 2010, Providence, RI
The 1000 Genomes Project aims to provide detailed genetic variation data on >1000 genomes from worldwide populations using the next-generation sequencing technologies. Some of the samples utilized for the 1000 Genomes Project are the International Hap-Map samples that are composed of lymphoblastoid cell lines (LCLs) derived from individuals of different world populations. The detailed map of human genetic variation promised by the 1000 Genomes project will allow a more in-depth analysis of the contribution of genetic variation to drug response. Future studies utilizing this new resource can greatly enhance our understanding of the genetic basis of drug response and other complex traits.
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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
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.
Software Engineer – Computational Biology Center
Memorial Sloan-Kettering Cancer Center seeks an Engineer to design and develop complex data analysis systems in support of cancer genomics research projects at the Computational Biology Center. Qualified candidate will have a BA, 5+ years of software development experience and expert knowledge of Java, SQL, and HTML.
Apply: www.mskcciscareers.org. Equal opportunity and affirmative action employer.
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