Jim Walker, chairman and CEO of clinical and regulatory systems firm Octagon Research Solutions, announced that it has completed the conversion of electronic clinical study data to CDISC’s Study Data Tabulation Model (SDTM) format in over 100 studies across eight therapeutic areas and 2,500 domains. Dave Evans, Octagon’s chief information officer, noted, “We have gained significant experience with the SDTM in the last year. Our team participated in the development and testing of the specification and used that experience to design our processes and apply appropriate technologies. We are now building on these experiences as the foundation for developing data standards governance models for our clients.”
Clinical trial simulation company Pharsight provided an update on its Cooperative Research and Development Agreement (CRADA) with the FDA’s Center for Drug Evaluation and Research (CDER). The CRADA collaboration directly supports FDA’s chronically underfunded Critical Path initiative. Shawn O’Connor, the company’s president, CEO and chairman, said: “We are utilizing the agency’s feedback to further customize Pharsight knowledgebase server to meet industry data management and analysis needs. We believe that our software tools offer tremendous value to drug developers and believe that FDA’s positive engagement in our CRADA underscores this belief.”
Jubilant Organosys plans to acquire contract research and manufacturing services, drug discovery and CRO segments in the U.S. and Europe. It has allocated $100 million for the acquisitions. A deal for the CRO firm in Europe could be in the range of $5-10 million. “We have around $100 million in our books, which we had raised through foreign currency convertible bonds. The company wants to be a service provider and outsourcing partner for major global drug manufacturers,” Jubilant Organosys’ R. Sankariah said.
ClinTec International, a contract research organization based in Scotland, is moving its global headquarters from Windsor to Glasgow. A regional grant of $2.7 million from Scottish Enterprise, an economic development agency, helped. The firm promised to create 240 new jobs over the next three years.
DecisionView, a provider of software for clinical trial budgeting and patient recruitment, appointed of Rene Pharisien as VP of worldwide sales. “His experience in building and leading high performance sales organizations in high growth technology companies will be a tremendous asset to the company,” said Steve Andrade, CEO of DecisionView.
Could Oracle and SAP use the courts to impede the rise of third-party firms that provide maintenance to enterprise applications? That’s the gist of a story about TomorrowNow, part of a cottage industry that offers cut-rate maintenance to household name software packages. Alas, some of the people at TomorrowNow have landed in hot legal waters, putting the future of the firm in doubt. Here’s a wire service story.
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