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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DIA 2010 – Innovation, Issues-Driven, Upbeat
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.
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DIA Bits & Pieces
Jun 15 | Announcements and products from the Drug Information Association meeting in Washington, D.C., June 13-17.
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A Social Approach to Patient Recruitment
Jun 7 | eCliniqua | Better use of Web 2.0 sites like Twitter, Facebook and PatientsLikeMe could be a boon for enrollment.
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Dana-Farber Chooses Clinical Research Management System
May 20 | News Brief | Dana-Farber/Harvard Cancer Center has chosen OnCore as their integrated clinical research management system.
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Quanticate Selects Oracle Argus Safety for Pharmacovigilance Database
May 17 | eCliniqua | Quanticate has selected Oracle Argus Safety as its safety database to offer comprehensive global adverse event management and reporting for its customers.
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Covance Launches Translational Services
May 13 | News Brief | Covance has created a Discovery & Translational Services group, which will integrate its discovery services, antibody products and immunology services.
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Reforms to Help Australia Maintain its Share of Global Trials
Apr 19 | eCliniqua | Australia is in the process of reforming itself to better accommodate the clinical trials industry amidst competition from emerging markets in Eastern Europe, Latin America, and Asia.
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Pen-Based Site Visit Reporting Solutions
Feb 10 | Expert Commentary | 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.
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Study Finds ‘Operational Gap’ in Clinical Trial Portfolio Management
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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Moonbay Sells Document Management Services Via Cloud Computing
Oct 20 | Moonbay Technology entered the field of regulatory document management and electronic submissions in June with an option affordable even to small biotechnology firms heretofore reliant primarily on homegrown, error-prone systems.
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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.
BPM-Based Case Management Approach to Optimizing Clinical Trial Efficiency Business Process Management (BPM) software offers liberation in the planning and management of clinical trials today. SmartBPM provides the components for automating critical clinical trial processes ranging from protocol development and patient enrollment to site management and investigator payments. Advantages are: - Potentially stunning return on investment at multiple levels.
- A 500%, or better, increase in application development time by directly executing business requirements
- Improved customer retention
- A 50% possible reduction in training time
Discovered is opportunity to enhance relationships with investigators, subjects, and regulators while bringing momentum to a technology-impaired study startup phase. Learn more about SmartBPM in this complimentary white paper.
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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More Podcasts
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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