The “approvable” letters that the FDA formerly sent out to gently reject drugs will be dropped in favor of “response” letters. Here’s a Q&A and the official news release.

Octagon Research, a provider of systems for regulatory data, said 100 customers are using its Starting Point templates for regulatory documents. The software supports submissions using the electronic common technical document (eCTD) format. “These tools are clearly gaining momentum with sponsor companies that want to move forward with electronic submissions in the most efficient manner,” noted John Lawrie, Octagon’s VP of process Solutions. Here’s the release.

Rho, a contract research organization (CRO) said that Katherine Monti, senior statistical scientist, has been elected to lead the biopharmaceutical section of the American Statistical Association (ASA) for a three-year term. Monti says she is “looking forward with enthusiasm to working with colleagues on the section’s executive committee to continue and expand services to our members. As my role as chair-elect in 2009, I will need to be making various appointments in the section, and I will need volunteers to fill those spots. I would genuinely be delighted to hear from anyone who is interested in becoming more involved.” Here’s the release.

If you work in information technology (IT), Computerworld magazine says, Quintiles is one of the best places to reset passwords and troubleshoot Microsoft’s Vista operating system. Here’s the release.

The Halifax Group and SV Life Sciences announced the completion of a capital infusion into Trio Clinical Research. Trio co-founders Faye Woolf and Betsy Brown retain a significant equity stake in the company and will continue to lead the management team. “We are extremely proud of Trio’s progress and growth since our founding in 2003,” said Woolf. “Most of all, we are proud of the quality of the service we provide to more than 35 customers across the biopharmaceutical sector.” Here’s the release.

Chip Jennings, the CEO of etrials, resigned suddenly. He had been with the firm for a bit more than a year, and had tried to elevate the service provided by the clinical trial technology suite. But competition in the electronic data capture and electronic patient diary sectors remains brutal. The firm tapped Chuck Piccirillo, etrials’ VP of technology, as interim president and chief executive officer. Here’s the official statement.

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