The Clinical Data Interchange Standards Consortium (CDISC) has released a new version of the Study Data Tabulation Model (SDTM), plus an implementation guide and metadata submission guidelines. Public comments on the documents are welcome until the end of next month. Changes in the new version include recommended solutions for signs and symptoms, findings about events or interventions, and ways to handle questions with multiple answers. This draft also includes new domains pharmacokinetics and microbiology. Since the FDA is believed to be transitioning toward requiring the use of SDTM, forward-looking sponsors are paying close attention to the CDISC effort. To get up to speed on the most recent version of the SDTM, CDISC is having three different webinars on August 14, 15 and 27th.

Simcyp, a research-based drug development and information management consultancy, named Malcolm Rowland as chairman of its scientific advisory board. The appointment has been made so that Simcyp can maintain and enhance its leadership in the field of predictive pharmacokinetic modelling. Rowland is the professor emeritus of the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester. Geoff Tucker, chairman of Simcyp, said, ‘We are delighted that an individual of such experience is joining our Scientific Advisory Board, and we look forward to working closely with Malcolm as the Company develops into new areas of pharmacokinetic-pharmacodynamic simulation and modelling”.

Quintiles Transnational, the largest contract research organization (CRO), will be developing a new 10-story office tower within Tri-Properties’ Imperial Center mixed-use complex at the intersection of Interstate 40 and Page Road as its new headquarters. Chairman and founder Dennis Gillings, chose to keep the location of the headquarters in North Carolina and further add 1,000 jobs. The company will also receive $25 million as incentives to maintain its location for its headquarters. Construction is expected to begin in fall 2007. This As a part of the company’s expansion plan, Quintiles plans to maintain its presence in two of its current locations, even after its new headquarters opens. Mike Mortimer, Quintiles’ executive vice president of human resources said, “Since December, when we first announced intentions to continue growing our presence in the Triangle area, we’ve already hired 225 new employees locally. Globally we brought on nearly 2,000 new employees in the second quarter alone. Unprecedented growth in the CRO industry is the primary reason behind our decision to expand our local presence.”

Verticals onDemand, a provider of Software as a Service (SaaS) solutions for CRM for the pharmaceutical industry, and HighPoint Solutions, a life sciences IT consultancy, have entered into a strategic partnership to provide pharmaceutical and biotech customers with complete implementation, integration, and support services for VBioPharma CRM implementations. Verticals onDemand has initially designed and built VBioPharma to support the unique needs of niche areas in the biotech and pharmaceutical industries. The product lines provide all the features of a CRM suite and all the SaaS benefits of the Salesforce Platform. Matt Wallach, vice president of sales and marketing of Verticals onDemand said, ”Verticals onDemand has taken off incredibly fast, so we are working hard to establish a reliable partner base to support customer needs. HighPoint was an obvious match for us with its rich pharmaceutical industry expertise and outstanding technical talent.”

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