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| IN THIS ISSUE |
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TGen Targets Cancer with Molecular Directed Therapies
By Deborah Borfitz
Do cancer patients respond better to an onco-genomic guided therapy than a doctor's "educated guess"? Results of a landmark molecular profiling study will provide the answer and, if it's yes, will likely spur interest in the concept as a way to increase treatment success while lowering development time and expense, says Stephen Anthony, DO, director of TGen Clinical Research Services at Scottsdale Healthcare in Scottsdale, AZ.
The $6 million project is sponsored by TGen (Translational Genomics Research Institute) and Scottsdale Healthcare, the company's clinical unit, and funded through an endowment from the Stardust Foundation. The late Debi Bisgrove, who co-founded the foundation with her husband Jerry, was a patient of Scottsdale Healthcare and intrigued by the molecular profiling concept, says Anthony.
The molecular profiling study began in September 2006 and patient accrual will be completed by the first quarter of 2008, says Anthony. Nine investigative sites nationwide are participating in the 90-patient study. Qualifying criteria includes having completed at least two prior treatments in which cancer cells were non-responsive and being otherwise healthy and functioning well.
Read more.
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ISI Expands eCTD Options for Small and Mid-size Players
By Ann Neuer
Ready or not, here it comes.
Many large pharmaceutical companies are sitting pretty as the January 1, 2008, deadline approaches for required use of the electronic common technical document (eCTD) for electronic submissions to FDA. But the rest of the market -- small to mid-size players -- is in a very different place, says Lisa Meyer, director of marketing for Image Solutions Inc. (ISI), a provider of electronic submissions software and services.
"For a number of years, big pharma has been looking at the eCTD as a strategic trigger to examine how they conduct business and how they need to re-design processes to comply with changing regulatory requirements. Smaller players don't have the IT or regulatory resources to go through the process internally so they are turning to outsourcing," Meyer explains. Even bigger companies that have purchased publishing software are opting to outsource the preparation of electronic submissions to ensure that they are done in accordance with the FDA Guidance and in a timely manner rather than risk a "Refuse to File" decision or a protracted process.
Read more.
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| NEWS BRIEFS TrialStat expanded its international customer base with news that Notal Vision, an Israel-based medical device company specializing in the early detection of age-related macular degeneration (AMD), has selected ClinicalAnalytics 4.0 (CA) for a Phase II device trial that will occur in Israel and the United States. Notal Vision's flagship product is The Foresee Preferential Hyperacuity Perimeter (Foresee PHP), which is a non-invasive diagnostic tool for the detection and monitoring of wet AMD. The medical device company selected TrialStat for its on demand flexibility, the ability to attach images to eCRFs and import data from Notal Vision's medical devices. Read the press release.
OmniComm Systems announced that City of Hope (a recent license customer of OmniComm's TrialMaster product suite) and OmniComm are working together to develop a set of caDSR derived standardized case report forms and reporting tools to support National Cancer Institute (NCI) reporting requirements. These reusable forms and tools will be made freely available to other Cancer Centers by OmniComm and City of Hope following a formal process of user acceptance testing led by City of Hope staff. City of Hope intends to use these standardized forms and NCI reporting tools for the first trial that they put into production using their TrialMaster environment. Read the press release.
Octagon Research recently announced that it has completed the conversion of electronic clinical study data to CDISC SDTM format for over 100 studies across 8 therapeutic areas and 2,500 domains. The company also announced that the Clinical Data Interchange Standards Consortium (CDISC) awarded it STAR recognition "unwavering support of the CDISC mission and goals for the past five consecutive years." Read both press releases.
Eliassen Group, a consulting, staffing, and training firm, has received the 2007 Pfizer Development Operations' "Strategic Supplier Excellence Award." Eliassen's Bio-Pharma Consulting Solutions Group provides Pfizer with Functional Service Provider (FSP) solutions, supporting all therapeutic areas for clinical trials in Pfizer's global R&D operations, as well as Post Marketing Product and Commercialization support. This annual award recognizes FSPs working in support of Pfizer's Development Operations who have demonstrated consistent performance in the areas of quality, service delivery and reliability, innovation and business processes, as well as customer service and responsiveness. Read the press release.
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LIFE SCIENCE JOBS
Director of Strategic Business Management - SAIC-Frederick, Inc.
SAIC-Frederick, Inc. is seeking a leader to manage strategic business opportunities, initiatives, partnerships, alliances, and joint ventures associated with the Advanced Technology Partnerships Initiative (ATPI). The newly created ATPI seeks to accelerate delivery of effective therapeutic and diagnostic modalities to cancer patients using advanced technology platforms and public-private partnerships. Learn more at www.saic.com or http://ncifcrf.gov or contact Mary L. Siegle at sieglema@mail.nih.gov.
Director of Information Systems - SAIC-Frederick, Inc.
SAIC-Frederick, Inc. is seeking expert in all areas of information services, including security, disaster recovery, remote access, database administration, operations systems design, programming, and communication. Direct a staff of 40+ within the Advanced Biomedical Computing Center (ABCC) the National Cancer Institute's fully integrated supercomputing facility for biomedical research. Competitive salary/benefits package. Learn more at www.saic.com or http://ncifcrf.gov or contact Mary L. Siegle at sieglema@mail.nih.gov .
Software Engineer, Bioinformatician - Job #07-052
The Institute for Systems Biology's (ISB) Computational Core seeks qualified candidates to join its growing bioinformatics team. For a full description and application instructions, please visit http://www.systemsbiology.org/careers. ISB is an M/F/D/EOE.
To have your job openings featured here, contact Lynn Cloonan for more information.
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FEATURED EVENTS
Laboratory Informatics, March 25-April 3, 2008 San Francisco CA.
IQPC's 3rd Laboratory Informatics conference is timed to influence developments in a rapidly advancing field by bringing together the major users and providers in the broad field of laboratory informatics. The conference is targeted at decision makers, policy strategists, problem solvers, advisors, researchers and consultants in the fields of chemical and laboratory informatics. click here for more information.
Lean Six Sigma for Pharmaceutical, Biotech, and Medical Device Excellence
February 25-27, 2008, Philadelphia, PA
At the 5th Lean Six Sigma for Pharmaceutical, Biotech and Medical Device Excellence we will bring you case studies that tackle the problems you are encountering, provide you with real-world solutions to your problems and introduce you to industry peers who have been able to overcome many of the challenges that Lean Six Sigma presents. Click here for more details
The Association for Laboratory Automation (ALA) presents LabAutomation 2008, January 26-30, in Palm Springs, CA. LabAutomation2008, the world's largest conference and exhibition focused exclusively on the rapidly growing field of laboratory automation, brings together a diverse group of academicians, scientists, engineers, business leaders, post-docs and graduate students from around the globe. For more details clicks here
Best Practices Awards Program - April 29, 2008
Bio-IT World announces its 2008 Best Practices Awards Program and calls for entries. Established in 2003, this prestigious award program recognizes the innovative utilization of technology and business strategies to accelerate drug and clinical development and ultimately improve human health. Click here for complete details and submit your entry today!
MIT Advanced Study Program - Register for Spring 2008
Put MIT to work for you. The MIT Advanced Study Program (ASP) is now accepting applications for the Spring 2008 term. ASP provides full and part-time certificate programs to working professionals at any stage of their careers. The program includes a flexible curriculum of MIT courses designed around the goals of participants and their sponsors. Visit our website to view participant profiles & comments, watch our program video, and find out if MIT is right for you. http://web.mit.edu/mitpep/go/asp08-bioit.html
To have your event featured here, contact Lynn Cloonan for more information.
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| FEATURED CONTENT |
Master Control
How Effective Document Management Can Help Accelerate Time to Market
How Effective Document  Management Can Help Accelerate Time to Market In the drug development process, time is indeed money. So it only makes sense to try to reduce delays in every phase of the process and speed up time to market. But how and where do you begin to save time? This white paper suggests that you start with the most basic activity-document management. This white paper discusses how effective document management can accelerate time to market
Click here to download whitepaper
Waters Streamlining the Chromatographic Method Validation Process
Chromatographic method  validation is a critical step in the workflow of pharmaceutical, food safety, chemical, and environmental laboratories. It can adversely impact regulatory compliance, product development, and ultimately product release and availability. Empower 2 Method Validation Manager is a business critical software that reduces the time and costs required to perform chromatographic method validation by as much as 80%. This whitepaper discusses how.
Reduce time/cost to perform chromatographic method validation-Download Free whitepaper!
To have your white paper featured here, contact Lynn Cloonan for more information.
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| EXCLUSIVE WEBCAST |
NEW! Life Science Webcasts from Bio-IT World and Cambridge Healthtech Media Group
Bio-IT World proudly introduces Life Science Webcasts -- a series of informal conversations with leading researchers and executives in the bio-IT and biopharma arena. This week, Dr. Jerald Schindler (VP, late stage clinical development statistics, Merck) discusses e-clinical research with Bio-IT World's Kevin Davies.
View the Webcast Now
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| Contact the Editors |
We invite your comments and feedback for this edition of eCliniqua. We also welcome proposals from all readers for guest commentaries on topics of broad interest to the e-clinical trials industry to appear in eCliniqua.
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