BRIDG Moves Toward Double Layer of Semantics

STANDARDS
BRIDG Moves Toward Double Layer of Semantics
By Deborah Borfitz

Subject matter experts and information technology (IT) professionals involved in clinical trials should both be happier with the next release of BRIDG (Biomedical Research Integrated Domain Group), the domain analysis model aimed at synchronizing semantics within the clinical research and healthcare enterprises. Semantically speaking, BRIDG will be taking a “two-layer approach” that incorporates accepted clinical terminology and definitions as well as technical representations around which software programs and messages can be written.

So says Julie Evans, senior director of technical services at the Clinical Data Interchange Standards Consortium (CDISC). Five years ago, CDISC initiated construction of BRIDG to support harmonization of its own set of standards as well as to “interface more cleanly” with Health Level Seven (HL7), the standards-settings organization for electronic interchange of clinical, financial, and administrative information among healthcare-oriented computer systems. Since then, the National Cancer Institute (NCI), Food and Drug Administration (FDA), and HL7’s Regulated Clinical Research Information Management (RCRIM) Working Group have joined the effort. Read more.

ACQUISITIONS
Clarix IRT Becomes Property of Phase Forward
By Deborah Borfitz

Responding to intense interest among study sponsors and investigative sites for consolidated technologies, Phase Forward invested $40 million in cash to acquire privately held Clarix LLC in early September. The move tightly integrates Phase Forward’s flagship InForm electronic data capture (EDC) system with Clarix’s interactive response technology (IRT), which has done more than its competitors to augment the traditional telephone interface with the power of the Web.

So says Phase Forward Vice President Martin Young, noting that the company has worked with more than 10 different IRT providers across roughly 100 clinical trials. That Clarix has a fully Web-integrated model for subject randomization, predictive medication inventory management, and operational management and reporting is only one of its chief attributes. Clarix also allows clinical teams to build their own ad hoc reports during the course of a trial and not just use the standard, preconfigured ones. Read more.

CORPORATE PROFILE
Pain Relief Studies Drive Growth of Lifetree Clinical Research
By Deborah Borfitz

Lifetree Clinical Research has come a long way in a short time. When the Salt Lake City, UT-based clinical research organization (CRO) launched in March 2003, it offered only investigative site services at a small, private pain clinic. Co-owners Lynn Webster, MD, and Alice Jackson, RN, each put up less than $100,000 to begin operations. Within its first year of business, Lifetree was generating enough profits to build a free-standing clinical research facility where Webster’s pain clinic would co-locate, says Jackson, Lifetree’s CEO.

Client demand quickly transformed Lifetree into a “specialized research organization,” says Jackson, who has been doing analgesia studies for 20 years. “In our business plan, we never dreamed we would offer full-service CRO services within five years. We started small and put good processes and quality initiatives in place,” including training curriculum and standard operating procedures governed by FDA regulations. Read more.

News Briefs - Sept. 29, 2008

• CDISC awarded contract for training of FDA reviewers
• Nextrials expands its executive team
• ACORN appoints Tara Webb senior director of CRO business development
• Good Products and Adlib Software partner in pharmaceutical regulatory submissions
• Paradigm Spine to implement PharmaPros’ automated trial management solution . . . more

LIFE SCIENCE JOBS

Lilly Singapore Center for Drug Discovery (LSCDD) - Associate Director of Informatics,
Lead and mentor a strong team for the Bioinformatics group at the Integrative Computational Sciences (ICS) department at LSCDD towards the development of novel algorithms, data analysis methods and software tools for drug discovery. Work closely with the Software Engineering group at ICS, and collaborate with the Discovery IT organization in Europe and USA. For additional information, or to apply visit: LSCDD

Lilly Singapore Center for Drug Discovery (LSCDD)- Senior Bioinformatics Scientist,
Contribute to the development of novel algorithms, data analysis methods and software tools for drug discovery as part of the Integrative Computational Sciences (ICS) department at LSCDD. Work closely with informatics and software engineering peers at ICS, and collaborate with the Discovery IT organization in Europe and USA. The successful candidate will offer hands-on insight and expertise in tailored therapeutic informatics and statistical analyses at the post-genomic era. For additional information, or to apply visit: LSCDD

Lilly Singapore Center for Drug Discovery (LSCDD) - Manager, Software Engineering (Integrative Computational Sciences)
Join the Integrative Computational Sciences (ICS) department at Lilly Singapore Centre for Drug Discovery (LSCDD),as Manager Software Engineering. Lead the development of integrated applications to process and visualize data from cutting edge technologies used by scientists at Lilly Research Labs (LRL) and the Drug Discovery Research (DDR) teams. Masters in Computer Science/Engineering or related discipline, 10+ years post graduation experience , 2 years management experience needed. For a complete job description and requirements or to apply visit: LSCDD

Lilly Singapore Center for Drug Discovery(LSCDD) -Senior Software Engineer,
Join a strong team of software engineers in our Integrative Computational Sciences (ICS) at LSCDD. Collaborate with, and help develop integrated applications to process and visualize data from cutting-edge technologies used by scientists at Lilly Research Labs (LRL) and the Drug Discovery Research (DDR) teams. The Software Engineering team provides computational tools and tailored software solutions that enable the global effort of Tailored Therapeutics; ‘The Right Drug, at The Right Dose for The Right Patient at The Right Time'. For additional information, or to apply visit: LSCDD
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DIA 2nd Annual Clinical Forum: Data Driven Drug Development Decisions October 20-23, 2008 | Ljubljana, Slovenia

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