Leo Pharma, a pharmaceutical company specializing in treatments for dermatological and vascular-related conditions, has upgraded to Oracle Remote Data Capture (RDC) Onsite 4.5.3. The company first deployed Oracle RDC in 2005, which helped it lower time from the last patient visit to database lock from 6-12 weeks to 1-2 weeks.

Aris Global, a provider of drug safety and document management software, announced the general release of ARISg 6.1. It includes an updated user interface. Wim Cypers, VP of product management, said: “Our customers, which include twenty of the top fifty pharmaceutical companies, rely on ARISg to deliver the functionality needed to easily and effectively address their increasingly complex regulatory obligations for drug safety. In release 6.1, we have responded to the feedback of our customers and enhanced ARISg’s user interface, incorporating role-based functionality, and delivered critical new features that secure its position as the leading pharmacovigilance system in the marketplace.”

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SAS, the statistical powerhouse, debuted SAS for Patient Safety at the DIA 44th annual meeting. Our story on the software is here. The software will provide advanced analytics for signal detection and pharmacovigilance, taking into account both new FDA guidance and emerging and established CDISC standards. “SAS for Patient Safety combines data standardization, regulatory-driven reporting and the most advanced analytics available for signal detection and pharmacovigilance,” said Jason Burke, worldwide director of health and life sciences at SAS.

By a 14-2 vote, an FDA advisory group recommended that the agency require that the cardiovascular risks of diabetes drugs be studied more closely. Some of the research could be completed after a drug’s approval. The tone of the hearing appears to have been polarized. Industry critic Steve Nissen said FDA officials have “‘the irrational belief that lowering blood sugar using virtually any pharmacological means will produce’ better results for patients,” according to this story in the New York Times.

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Quartesian, a contract research organization, selected OpenClinica as its electronic data capture (EDC) solution for its clients’ clinical trials. Said Benjamin Jackson, Quartesian president and CEO. “We have chosen OpenClinica as our EDC solution in part because it fits our current business need for low cost rapid implementation of EDC for Phase I trials. It also aligns with our strategy to bring our infrastructure and processes for data management in line with the current thinking of open source systems, data interoperability and the re-engineering of the clinical trial process.”

Premier Research, a contract research organization (CRO) said a subsidiary, Premier Research Group SA, earned ISO 13485:2003 certification in support of its global medical device operations. The ISO standard is a stringent, globally-recognized benchmark for management systems for medical device manufacturers and service providers. “The achievement of ISO 13485 certification demonstrates that Premier Research Group has built a quality system which will continue to ensure outstanding delivery to our customers of all our medical device services,” said Philip Butler, executive VP of strategic development.

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