The FDA may allow Australia’s Marshall Edwards an early approval after an interim look at data from an ongoing, 340-patient ovarian cancer trial. The company says that FDA’s “special protocol assessment (SPA)” program “provides for an interim analysis of the data, which, if statistically significant, can be used to support a request for accelerated marketing approval. An analysis of interim results will be possible after patient recruitment to this study is completed and 95 patients have disease progression,” the company says. Here’s the release. There is a guidance document about the FDA SPA program here.

Drug safety software firm Sentrx said it has five new long-term contracts and 30 customers. “This has been one of the most successful quarters in Sentrx history,” said Joseph Albano, CEO of Sentrx. “We appreciate the confidence our newest clients have placed in us, and we will strive to exceed their expectations.” Here’s the release.

etrials reported quarterly earnings. Revenues fell 9 percent, to $4.3 million. Its losses doubled, to $2 million. The firm remains upbeat. “Our qualified pipeline is up nearly 50 percent; our close rates nearly doubled over last year; and we closed a number of multi-product solution sales with both new and existing clients. The sales metrics we follow are improving and we are where we planned to be at this stage of our sales re-engineering efforts,” said Chip Jennings, president and chief executive officer. Here’s the official statement.

Bio-Imaging announced quarterly financial results, with quarterly revenues up 29 percent and profits doubling. The company recently acquired Phoenix Data Systems (PDS), a provider of electronic data capture. “We are extremely pleased with the ongoing integration of PDS with Bio-Imaging,” says Mark Weinstein, president and CEO. “The acquisition of PDS expands our core clinical trial services business into the rapidly growing electronic data capture market and leverages our global operational capabilities and sales and marketing reach into pharmaceutical and biotechnology companies.” Here’s the release.

ClinPhone announced its annual financial results. Revenues for the firm for the year ending in February, 2008 were up 9.8 percent, to $92 million. But the company reported a $3 million loss in 2008 after a profitable 2007. The company’s annual report lists major service problems during 2007, affecting four customers, and specifically targets an unidentified IBM operating system as the root of some of the problems. The company fired 40 people in its randomization and supply group in the aftermath of the outages, and saw some customers depart or postpone purchasing decisions. “Those customers affected cancelled some future [randomization] business that they were about to place with ClinPhone, and others became concerned that they might be affected and delayed award of business. This resulted in a significant reduction in the order book,” the company stated. On the brighter side, ClinPhone added 37 new customers—and its electronic data capture revenues have grown by 70 percent, faster than most competitors. Here’s the PDF.

ICD Global announced warehousing and worldwide distribution for patient recruitment literature and marketing kits. “We understand what clinical trial managers go through to get and retain patients,” said Steve Horstmann, president of ICD Global. “When it can take up to 200 calls to secure a single clinical trial participant—a huge investment in time and labor—pharma companies can’t afford a logistics mistake at the end of the line. ICD ensures that the right materials get to the right site at the right time to keep their trial moving forward.” Here’s more information.

In a vindication of electronic patient diaries over paper booklets, Sucampo Pharmaceuticals and invivodata announced that patient-reported outcome devices had been used in winning FDA approval of a new indication for Amitizia (lubiprostone). “We are very pleased with invivodata’s contributions to this program and their ability to accurately capture the critical data we needed to support FDA supplemental approval of Amitizia,” said Gayle Dolecek, senior VP of research and development at Sucampo. “Their staff was very knowledgeable about the scientific and practical aspects of PRO data collection, and their processes were found to be regulatory compliant during an FDA audit of their systems and practices, which was an important component of this approval.” Here’s the FDA statement from April, 2008, and yesterday’s news release from invivodata.

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