Qumas: eCTD Compliance Can Be Time-Consuming
By Deborah Borfitz

Procrastinators, take heed. If you act now, you may be able to meet the FDA's new eCTD mandate for regulatory submissions by mid-year. It will take at least that long to get an electronic system installed, load it with the appropriate documents, and make decisions about the use and ownership of the metadata, says Warren Perry, compliance advisor for Qumas, a Cork, Ireland-based document management company.

The FDA has been telling companies "in no uncertain terms" that the common technical document (CTD) is the only acceptable submissions format, says Perry. "[Industry] can't do NDAs [new drug applications] or INDs [investigational new drug applications] anymore. The only choice left is whether to do an electronic or paper CTD."

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Clinical Force: Managing the Site Payment Process with CTMS
By Deborah Borfitz

For clinical trial sponsors seeking to recruit and retain capable investigators, improving the site payment process may be their best move. Prompt, accurate, and itemized compensation tends to translate into happy and conscientious investigative sites - and quicker study closes.

So says Marcus Thornton, CEO of Raleigh, NC-based Clinical Force, a player in the growing clinical trial management system (CTMS) market dominated by Oracle eClinical, Perceptive Informatics IMPACT, and ClinPhone. Increasingly, sponsors are purchasing CTMS specifically to deal with their payment woes.

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Nextrials Links Clinical Data to the iPhone
By Ann Neuer

Nextrials Inc. recently announced that Prism, its integrated clinical trial management and electronic data capture (EDC) product, is now accessible via the Apple iPhone. With this capability, investigators on-the-go need look no further than their pockets to complete and sign off on electronic case report forms (eCRFs), run reports, or check on enrollment progress. Clinical research associates (CRAs) sitting in airports will be able to verify that investigative sites are entering data in a timely manner and view open queries without firing up the laptop.

Alan Arroyo, senior director of business development, says, "It's really very straightforward. The iPhone uses Apple's Safari Web browser, which is the same browser in Apple's desktop products. The user needs to de-activate the pop-up blocker, and then simply tap on the Internet feature. Prism could be bookmarked and easily launched. The user would then just need to log in to Prism. With a few taps, the user has access to the database he or she has privileges to view." Data entered into eCRFs via the iPhone are encrypted and sent to the same central database as data entered on any computer using Prism.

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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 [email protected].

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 [email protected]

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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.