Clinipace, a provider of electronic data capture, announced ten new contracts collectively valued at more than $1 million. The North Carolina firm estimates it can offer cost savings of 30-50 percent compared to what more established competitors charge. “We are committed to serving the needs of emerging and mid-tier biopharmaceutical and medical device firms, as well as academic researchers, research networks, and foundations,” said Jeff Williams, CEO. “These organizations have been largely ignored by established eclinical software vendors because of their size and budget constraints.” Here’s the release.

Is the FDA setting the right priorities? Predictably, a Congressperson is not sure about that and has launched a probe after unearthing a 2007 to-do list for the agency from an FDA attorney. Rep. Henry Waxman of California charges that the items on the list are designed to help the industry at the expense of the public. Here’s a wire service story.

The Food and Drug Law Institute (FDLI) has published a comprehensive guide on off-label communications. It was designed for pharmaceutical firms, medical device companies, life science attorneys, sales teams, compliance officers and regulatory affairs specialists. Price: $149.

Soleil Securities announced coverage of Omnicare. The firm says: “In our opinion, limited near term upside potential with stock rebound after management increased guidance following 2QR. Despite an on-going major initiative to enhance operating efficiency and increase customer growth, significant issues remain.” Hat tip to StreetInsider.com

Despite apparently good clinical trial data, MannKind saw its shares pounded on Wall Street. The firm’s inhaled insulin product is benefiting from Pfizer transitioning patients off its similar to-be-discontinued Exubera product; the big pharma is even paying for some patient medications. The Los Angeles Business Journal has a story. This is the company statement.

The Clinical Data Interchange Standards Consortium (CDISC) won a coup: a contract to train FDA reviewers in the nuances of regulatory submissions. The agency is clearly moving toward an environment in which adherence to CDISC standards is a regulatory obligation, not a preference. Specifically, the press release states, the courses to be taught over the next two years will include: CDISC Basics, the CDISC Study Data Tabulation Model (SDTM), the CDISC Analysis Data Model (ADaM) and Advanced Topics on CDISC Standards. “CDISC is extremely pleased to have been selected to continue to provide CDISC standards education within FDA, an acknowledgement of the value these standards bring to the review process,” said Rebecca Kush, CDISC president and CEO.

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