Cato Research, a contract research organization, and Neuland Laboratories, a contract manufacturer, announced a new joint venture that will establish a company in Hyderabad, India. Cato Research Neuland India, as the company will be called, will bring innovative drugs to market while using high quality and cost effective resources located in India. Cato Research will provide business development, training, senior management recruitment and implementation of SOP guidelines. In collaboration with Cato BioVentures, the venture capital arm of Cato Research, Cato Research will also support clinical studies, data management, statistical analysis and regulatory services. “This joint venture further allows Cato to expand its international presence and better serve our sponsors,” said Allen Cato, CEO of Cato Research. Here’s the release.
A new full-day mock-trial program “A Day in Court: Critical Implications for Conducting Clinical Trials” will be presented by the Regulatory Affairs Professional Society (RAPS) on July 24, 2008, at The George Washington University Cloyd Heck Marvin Center, Washington, DC. The program discovers how failure to adhere to standard operating procedures (SOPs) and quality standards (QS) can lead to legal action through a fictional case based on a real-life situation. The program will also address common violations throughout the increasingly complex and demanding clinical trials phases and will provide you with guidance on how to recognize and eliminate legal and regulatory liability. Developed in collaboration with the American Health Lawyers Association (HLA), the mock trial program will include direct and cross-examination testimonies, jury deliberation and verdict discussion and additional Q&A from expert regulatory professionals. For further details, visit RAPS’ website.
Barnett International, a division of Parexel International, a consulting services and targeted education and training program provider, announced that it will conduct a basic statistical concepts workshop “Statistical concepts for non-statisticians” with direct applicability to clinical research. This is not a course on statistical formulas or computations. The course has various topics of interest to the clinical trial community. Elkan Halpern will instruct the course. For registration and further details, visit Barnett International’s website.
XClinical, a supplier of electronic data capture, announced its participation at the CDISC Interchange in Tokyo, Japan. The exhibition will take place jointly with Asklep, an Intage group company, XClinical customer in Japan. “Asklep is the first Japanese CRO to join CDISC and having a CDISC ODM certified partner like XClinical certainly speeds up our goal for having a global standard EDC solution for our clients here in Japan” said Toshio Yoshii, director of the clinical information division at Asklep. XClinical executives will be involved in both CDISC presentations and training sessions. Here’s the release.
The Accelerated Community Oncology Research Network (ACORN), an oncology-focused CRO and research network, announced its expansion of the company’s technological infrastructure with a proprietary oncology-focused data warehouse. We’re starting to see more CROs advertise what systems they’re using. Integrating patient-reported outcomes (PROs), electronic medical records (EMR), claims data, and laboratory information systems, ACORN’s data warehouse offers reliable information solutions to payers, financial institutions, pharmaceutical/biotech companies and community oncology practices. According to ACORN CEO Steve Coplon, “We are not just the purveyors of data; we analyze it, and provide solutions through our multi-modal capabilities. Our national network of oncologists, nurses, and practice administrators works closely with our PhD statisticians, psychologists, and health economists on staff to conduct unique analysis, which has been well received across multiple industries.” Here’s the release.
Rho, a full-service contract research organization (CRO), announced growth. Over the past 18 months, Rho has expanded its staff by more than 200 percent in such areas as project management, clinical operations, regulatory affairs, and product safety. Kathie Whitesell, director of clinical operations, has been guiding the process since she joined the firm in March of 2006. The company recently recruited Kristen Snipes, senior project manager, and Haifa Tyler, project manager. Patrick Loebs joined Rho in January 2008 as the senior director of regulatory affairs and medical writing. “We are very excited about our recent additions and promotions,” says Russ Helms, chief technology cfficer of Rho. Here’s the release.
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