CytoDyn picked Target Health for the preparation and electronic filing of CytoDyn’s upcoming FDA application using Target Health’s proprietary electronic case report forms (e*CRF) system, which offers a paperless approach to FDA filings, including submission of electronic INDs and electronic common technical documents (eCTD). Dow Pharmaceutical Sciences, King Pharmaceuticals and Pain Therapeutics have used the technology.

Arana Therapeutics named Alan Scott as VP of clinical research. Scott’s primary responsibility will be the operational management of Arana’s expanding clinical trial program. Arana CEO John Chiplin said: “Dr. Scott’s appointment provides us with the clinical bandwidth to help develop our pipeline. He is a globally experienced research professional who will be pivotal in the management of Arana’s clinical program and commercialization of our exciting antibody assets.”

A Congressional committee passed a bill with loans and other subsidies to encourage the use of electronic health records. Patient privacy issues will be downplayed, initially, to help win support for the systems but still allow use of the data by third parties. Here’s a story.

TUV SUD has completed the acquisition of MSource Medical Development to create a new life science business unit. “The opportunity to apply TUV SUD’s certification, testing and management skills to clinical research services is the main reason to make this important step forward,” said Peter Schaff of TUV SUD. “There is a distinct need for quality in each step of the clinical research process, while the complexity and global reach of clinical trials increase every year.”

The European Union launched the Impact on Clinical Research of European Legislation (ICREL), a survey to assess the impact of the European directive on clinical trials. d9A2t49mkex The information obtained will permit the EU to adapt current legislation of clinical trials and to identify the most promising pathways for improvement. Results will be presented in the European Commission in Brussels in early December 2008. Here’s the release.

The New York Times has a flattering portrait of Sweden’s artificial hip registry, and a jaundiced take on the inability of U.S. officials to create a similar database. Swedish surgeons stopped using one artificial hip after just 30 reports of problems. Investigating artificial joint problems in the U.S., in contrast, takes months or years, allowing continued sales of the devices and, eventually, a bonanza for personal injury lawyers. A quote from the article: “‘We are No. 1 both as a provider and user of implants,’ said Dr. John J. Callaghan, a professor of orthopedics at the University of Iowa. ‘We should be the leader in the follow-up of them.’ ” The story doesn’t cite any FDA authority or desire to fix the situation, but Kaiser Permanente does have its own registry.

Cutting Edge Information announced a 225-page benchmarking report, “Streamlining Clinical Trials.” The report addresses resource allocation, performance measurement, continuous process improvement, patient and investigator recruitment and adaptive trial designs. It includes more than 500 metrics and detailed case studies. “Clinical operations teams confront numerous internal and external challenges, which often result in delays that can end up costing pharma companies hundreds of thousands of dollars, if not more,” says report author David Richardson. “To be efficient, teams need creative approaches to challenges such as patient recruitment.” Here’s the release.

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