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DSG News Articles - 2009

New Risks Require New FDA Solutions

OCTOBER, 2009 A clear and present danger has emerged for the pharmaceutical and medical device industry that threatens its very core. After a wave of criticism about the way federal drug regulators are performing their duty, a Supreme Court majority handed down a decisive endorsement of lawsuits in state courts to address deficiencies at the national level.

100% EDC, A Necessity. From “Is 100% EDC Realistic?” presented by Suzanne Lamerand of DSG, Inc. at the 2009 SCDM Annual Conference, 2009.

The pharmaceutical and device industry faces a hostile litigious and regulatory environment. This current climate can stifle research and, as a result, impede progress that could improve the healthcare of all Americans. The concern is over a new level of scrutiny aimed at pharmaceutical and medical device companies. The good news is that the industry can employ existing technologies to head off potential problems and dramatically reduce risk. That technology is EDC.

DSG in the Spotlight at 2009 SCDM Annual Conference

(01 Oct 2009) -DSG's EDC technology presence at 2009 SCDM conference highly anticipated - MALVERN, Pa.--(Business Wire)-- DSG, Inc., the leader in EDC and clinical software technology, is already the center of attention leading up to the 2009 SCDM Annual Conference. The excitement is centered around DSG`s continuing role as a pioneer in the EDC(electronic data capture) field, with over 500 attendees eager to see the latest developments and the future of EDC from DSG.

Cipher Uses DSG`s EDC in Effort to Give Hope to Severe Acne Sufferers

Cipher Pharmaceuticals conducts Phase 3 trial study for new severe acne treatment- MALVERN, Pa.-- DSG Inc., an industry leader in clinical trial data collection and management, today announced that Cipher Pharmaceuticals (TSX:DND) is using electronic data capture (EDC) software and data management services from DSG. Cipher is using DSG`s eCaseLink for its Phase 3 dermatology study on its new compound for the treatment of severe acne. Cipher`s new treatment offers new hope for patients with severe inflammatory or recalcitrant nodular acne who are unresponsive to conventional therapy.

DSG’s Successes with Human Genome Sciences By Lisa Henderson | Published: September 2, 2009

In covering clinical trials, we are seeing more focus on the activities in specific therapeutic areas. Not that they didn’t exist before, but the frequency with which companies are identifying the specific conditions for which they have experience are on an uptick. These experiences can parlay into other contracts in similar conditions, or add to the company’s cadre of experience, as well as the overall impression, the company already exhibits.

Human Genome Sciences Achieves Lupus Drug Goals With DSG`s EDC

(17 Aug 2009) Human Genome Sciences announced that BENLYSTA met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). These results show that BENLYSTA has the potential to become the first new approved drug in decades giving hope to people living with systemic lupus. DSG supports HGS on four global Phase 3 studies concurrently, providing data capture and supporting data management through its function rich eCaseLink EDC software. The study included nearly 400 electronic case report forms per subject, which were highly complex in design and had nearly 1,200 edits per screen. DSG provided critical data reporting tools based on study requirements, allowing HGS data management personnel to continually monitor and efficiently insure data quality.

DSG Announces Record Growth for First Half of 2009

(22 June 2009) DSG Inc., the industry leader in electronic data capture (EDC) for clinical trial data collection and management, today announced, from the 45th Annual Meeting of the Drug Information Association, its continued record growth and profitability for the first half of 2009.

DSG, Inc. wins SCDM Data Driven Innovation Award for second year in a row

January. 13, 2009 DSG’s collaborative work with Human Genome Sciences wins key industry award...
In its second year, the Data Driven Innovation Award recognizes and honors excellence in the advancement of clinical data management and celebrates innovation in vendor/sponsor relationships. Three judges selected from the SCDM Certified Clinical Data Managers agreed to honor the partnership between HGS and DSG for creating an interactive and centralized Clinical Data Quality Control (CDQC) checklist that combines both system data and user entered data to assess the status of "cleanliness" for a given project.

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