A key committee in the U.S. House of Representatives passed a weaker version of user fee and drug safety legislation, dropping a requirement for FDA analysis of post-marketing data and avoiding a showdown over tighter rules about promoting drugs after they are launched as products. The legislation would mandate a database for clinical trial results.

SAS recently announced the expansion of the company’s efforts to support standards established by the Clinical Data Interchange Standards Consortium (CDISC), an independent medical and biopharmaceutical standards organization. SAS is helping in clinical research by developing a framework for loading electronic health record (EHR) data into SAS drug development using CDISC standards, allowing researchers to fully leverage EHR information in the clinical trial process. “Strong and efficient interfaces that link electronic health records with the pharmaceutical industry and regulatory authorities will enhance public health by improving both therapeutic product safety and efficacy,” said Edward Helton, chief strategist of regulatory and biomedical affairs, SAS. He’s also the chair-elect of the board of directors at CDISC.

ClinPhone, a clinical technology suite, announced it had signed an agreement with Chiltern for ClinPhone EDC. Chiltern, a CRO, has signed an agreement to implement ClinPhone’s EDC software. ClinPhone EDC is a data management system that unifies the functionality of paper data entry (PDE) with the flexibility of electronic data capture (EDC) into an electronic clinical data management platform. “Our sponsors’ success relies on our ability to capture, integrate and report their information. We will provide sponsors a seamless integration of Clinphone EDC with our clinical project management system and safety database to speed their clinical development and late phase initiatives,” said Jim Esinhart, executive vice president, biometrics and late phase at Chiltern.

Todd Hintze, principal, Everest Group, and Rich Kabrt, engagement director, Everest Group, will discuss managing and developing CRO relationships in a one-hour webinar on June 27, 2007. The Everest Group is a global consulting firm, will discuss and identify the outsourcing models relevant to CRO partnerships and the perceived risks and benefits of each model. Participants will develop a deeper understanding of outsourcing models that are being deployed in other industries and which models are appropriate for a CRO partnership. ClinPage interviewed Hintze earlier this year.

Clinsys Clinical Research, a clinical research organization, announced the expansion of its United States and European operations with new offices in Raleigh, North Carolina; Düsseldorf, Germany; and Gent, Belgium. “I am excited that our growth and need to service more of our sponsors’ global requests has required that we expand our United States and European operations,” said David E. Williams, Clinsys chief executive officer. “These expansions will allow Clinsys to offer a full range of clinical trial services in support of global as well as local clinical trials.”

GSK may not lose further market share in diabetes, a Wall Street firm predicts. Avandia sales have dropped sharply but leveled off since the New England Journal published its own analysis of the company’s trial data. “We think this may point to stabilization of Avandia’s U.S. share, making loss of the full franchise highly unlikely,” Marietta Miemietz, an analyst with Dresdner Kleinwort, stated in a recent research report. Here’s a news story on that report.

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