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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invivodata: FDA’s New PRO Guidance Highlights Patient’s Perspective
May 17 | eCliniqua | Evidence is mounting that the Food and Drug Administration (FDA) wants to hear the voice of the patient in clinical trials. "They want to make sure PRO data are collected in a reliable way so they can make reasonable judgments based on those data,” says Doug Engfer, president and CEO of invivodata.
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Harnessing (and Securing) Meaningful Health Data
May 3 | eCliniqua | “There isn’t going to be some massive database in the basement of the White House run by Sarah Palin,” promised John Halamka, the CIO of Harvard Medical School, in his keynote at the Bio-IT World Expo.
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The Reality of Medical Software Compliance
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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Peddicord: New Privacy Concerns with ‘HIPAA 2’
Jan 4 | eCliniqua | A new set of federal privacy and security requirements, introduced by legislation promoting the adoption of electronic health records (EHRs), “may make the investigator-CRO interface more complicated for some time.”
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Adverse Event Reporting Begins at Clinicaltrials.gov
Sep 21 | Starting on September 27, sponsors of industry-, academic- and government-run clinical trials will have to begin reporting adverse events on www.clinicaltrials.gov.
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BioClinica Acquires Tourtellotte Solutions
Sep 21 | BioClinica has acquired Tourtellotte Solutions, best known for its supply chain simulation and interactive voice (IVR)/interactive web (IWR) software.
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Will Regulated Product Submission (RPS) Trump eCTD?
June 26, 2009 | Just as the electronic common technical document (eCTD) is gaining traction as the required format for electronic regulatory submissions, the FDA is changing the game.
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Phase Forward Helps FDA, DoD Monitor Drug Safety
eCliniqua | The Department of Defense last year chose Phase Forward’s Lincoln Safety Group to support a new drug safety initiative, enabling it to provide the FDA with rapid assessment capabilities.
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Workgroup Sets Priorities to Harmonize Standards for EHRs and Research
eCliniqua | The much anticipated convergence of data between clinical trials and electronic health records (EHR) is heading toward reality with the recent formation of the EHR Clinical Research Value Case Workgroup.
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Etrials Purchase Would Make BioClinica Number Three EDC Player
May 8, 2009 | What reputable products and a succession of management teams couldn’t do for etrials Worldwide its soon to be owner most likely can boost stagnating sales and stem the red ink.
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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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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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