Parexel won an award for "research team of the year" from Scrip, an industry publication. The independent judges, according to the press release, "were particularly impressed with the clinical research team's ability to rapidly complete study start-up and implement the required time lines."

Adaptive trials are rare but not unheard of. This press release from Salix Pharmaceuticals describes an adaptive design for diarrhea in HIV patients that included two stages and doses. The project also used FDA fast track status and a special protocol assessment. Said executive VP and chief development officer Bill Forbes: "We have requested a pre-NDA meeting with the FDA and believe that a meeting could be scheduled by mid-first quarter of 2011."

NextDocs is having a webinar tomorrow on using the Microsoft Sharepoint system as a collaboration platform in clinical trials. It's free and scheduled for 2:00 p.m. Eastern time. You can sign up here. Is the line between a document management system and a clinical trial management system blurring?

The Association of Clinical Research Professionals (ACRP) and the Society for Clinical Data Management (SCDM) will form a partnership. They have a total of 22,500 members in their respective organizations. Said James Thomasell, the ACRP's executive director: “Our organizations are a natural fit both in terms of our missions and culture. We look forward to working closely with SCDM in advancing our missions and benefiting the clinical research enterprise.”

Medidata reported quarterly financial results. Revenue rose 17 percent, to $41.1 million; 35 percent of it came from outside the U.S. Profits rose 200 percent, to $4.6 million. Professional services revenue dipped slightly. The company spent $6.4 million on research and development during the period. "Medidata's business model of providing software-as-a-service tools, matched with the highest quality professional services, is generating industry-leading gross margins, while significant operating leverage is resulting in excellent earnings growth," said chairman and CEO Tarek Sherif.

We can't remember another company touting the simplification of its database, but that's the gist of this article mentioning iTrials. With information on one-quarter of the U.S. population, the Tennessee firm specializes in finding patients for clinical trials. “We were looking for solutions that would let us get to the data faster,” said Sean Harrison, iTrials' chief security officer and senior information architect. Searches on the company's system were taking too long. The company seems to have been dissatisfied with larger, slower databases developed prior to the ascendance of the internet. Instead, iTrials chose a "columnar" or "NoSQL" database. Such databases are tuned for high-performance tasks in ecommerce and other industries requiring blazing speed, which has never been a design criterion in the world of clinical trials.

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