Mission3, an Arizona-based provider of pharmaceutical project, document, and submission management software, announced that it continues its drive for good informatics practices through its partnership with LSIT Global Institute. LSIT has published an article by Dirk Karsten Beth, president of Mission3. Writes Beth: “The eCTD submission [electronic common technical document] standard is a small step in the right direction, but the giant leap comes from the IT infrastructure and integration that can really make the process flow seamlessly from bench—through regulator—to bedside. The true power of IT systems is first realized as the data flows freely from one system to the other and, as Life Sciences companies automate more processes internally, integration will lead to increased efficiency and quality.” The article is available at LSIT’s website. ClinPage wrote about Mission3 in this recent article.

Bio-Optronics, a New York-based work flow solutions company, announced that the company would be demonstrating Clinical Conductor, a site-centric clinical trial management system (CTMS) at the Drug Information Association’s 43rd Annual Meeting in Atlanta, GA, June 17-21. Clinical Conductor is a web-based CTMS for investigative research sites. The solution manages a research site’s entire operations, including studies, staff scheduling, visit scheduling, treatment tracking, sponsor reimbursement, finances, workload planning, recruitment, marketing, internal communications, site calendars and more. “Clinical Conductor is the most powerful CTMS available and at the same time, it’s affordable, easy to use and scalable,” said Bio-Optronics president, Mike Kamish.

TrialStat, an Ottawa, Canada, electronic data capture company, has announced the Canadian Stroke Network (CSN) is using its platform for a web-based stroke registry. CSN selected TrialStat’s Clinical Analytics (CA) tool because of an easy-to-use interface. “CA provides us with a platform from which to expand and enhance the registry of the Canadian Stroke Network,” said Dr. Kevin Willis, acting executive director of the Canadian Stroke Network.

We always cringed when the dotcom wizards said information “wants to be free.” Why doesn’t anything else want to be free? Does ice cream want to be “free”? Now David Weinberger, a savvy scholar at Harvard Law School, says information wants to be aggregated. He’s got an interesting angle. Weinberger has a short article (available online for $4) in the June, 2007, Harvard Business Review. He does not mention the drug industry, but his ideas are unsettling in the context of the NEJM aggregating Avandia safety data. “Resistance to aggregation is futile. Somewhere, undoubtedly, a couple of kids are sitting in a dorm room figuring out how to aggregate and disseminate your firm’s data,” writes Weinberger. In 2002, he published a book, which attracted impressive endorsements.

The New York Times is calling attention to physicians who have been reprimanded or seen their licenses suspended—but still work on clinical trials. The newspaper reviewed records in the state of Minnesota. The story highlights a psychiatrist named Faruk Abuzzahab, who has been repeatedly disciplined by state medical authorities but continues to work on clinical trials. The NYT identified 103 disciplined physicians in Minnesota who had helped with industry-sponsored research. Two had criminal convictions. Experts said the problem is national. “That drug makers are scraping the bottom of the medical barrel is an outrage,” said David Rothman, president of the Institute on Medicine as a Profession at Columbia. The story quotes a high-level FDA official, Janet Woodcock. Woodcock, according to the Times, says the agency “plans to require” that sponsors notify the agency when they discover investigators falsifying data; that is not required under current law. No timetable for that requirement was provided.

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