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NEW YORK, NY – July 14, 2009 – Medidata Solutions, a leading global provider of hosted clinical development solutions, today announced Switzerland-based NovImmune has selected Medidata’s Trial Planning product suite to support the development of its diverse pipeline of biologics for immune-related disorders. NovImmune has already utilized Medidata Grants Manager™ and CRO Contractor™ for a Phase II type I diabetes trial involving 160 patients and 75 sites in 12 countries, and is also incorporating Medidata Designer™ into its clinical development process.
NovImmune is currently working with seven compounds in several stages of development that are expected to have applications in multiple therapeutic areas. As a result, NovImmune’s clinical trials range in size, complexity and patient population and often require engagement with multiple contract research organizations (CROs) with varying and highly specialized areas of expertise. To improve trial planning, streamline contract negotiation and control costs, NovImmune chose to leverage Medidata Grants Manager – a solution built on Medidata’s exclusive PICAS® database, enabling fast and accurate budget forecasting for clinical sites – and Medidata CRO Contractor – built on the exclusive CROCAS® database, providing a clear framework for budget negotiation with CROs.
“Specializing in both immunology and biologics, we’re working within two of the fastest-growing areas of drug development,” said Jack Barbut, CEO, NovImmune. “Medidata’s trial planning tools are key to our ability to prioritize and make critical decisions about our strategy for multiple clinical development programs – from size to locations to cost to timing – so that we’re better equipped to manage and drive our pipeline.”
NovImmune has already experienced the benefits of Medidata’s trial planning products in developing a task and activity plan, using CRO Contractor for an important study where a CRO was engaged. The use of CRO Contractor enabled clear understanding and consensus on the tasks to be conducted, followed by expeditious agreement on the pricing based on the CRO Contractor benchmark costs.
NovImmune is also implementing Medidata Designer, which enables the standardized development of study protocols and simultaneous capture of all protocol metadata in a structured, CDISC ODM certified XML file that can be reused to rapidly set-up downstream systems, such as electronic data capture (EDC). As study protocols are developed, data extracted from Grants Manager’s PICAS repository enables ongoing evaluation of trial cost. As a result, NovImmune will be able to understand sites’ costs of executing the protocol as it is being developed.
“NovImmune is working to meet a critical market need with its focus on biologics and immunology, and we are pleased to support its efforts to improve the efficiency of its clinical development processes,” said Tarek Sherif, CEO of Medidata Solutions. “Medidata’s trial planning products will enable NovImmune to continue to make informed and strategic decisions about the therapies the company chooses to pursue and the varying resources they will need to be successful in clinical development.”
About NovImmune, SA
NovImmune SA (‘NovImmune,’ www.novimmune.com) is a drug discovery and development company with a focus on therapeutic mAbs for inflammatory diseases and immune-related disorders. NovImmune has generated, to date, seven proprietary mAbs. The pipeline is a balance of preclinical and clinical compounds, with a mix of both clinically validated as well as novel targets. Each of these portfolio products has the potential to become a medicine for multiple medical conditions due to the overlapping mechanism of action under laying these types of diseases. Two compounds are in clinical development, with the most advanced in clinical phase II. The lead product, NI-0401/anti-CD3, is currently being tested in Crohn’s disease, type I diabetes and transplantation. The company was established in 1998 and has currently 75 employees based in Plan-les-Ouates/Geneva, Switzerland.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of hosted clinical development solutions that enhance the efficiency of customers’ clinical development processes and optimize their research and development investments. Medidata products and services allow customers to achieve clinical results more efficiently and effectively by streamlining the design, planning and management of key aspects of the clinical development process, including protocol development (Medidata Designer™), investigator benchmarking and budgeting (Medidata Grants Manager™ accessing the PICAS database), contract research organization (CRO) benchmarking and budgeting (Medidata CRO Contractor™ accessing the CROCAS database), and the capture, management, analysis and reporting of clinical trial data (Medidata Rave®). Medidata’s diverse customer base spans pharmaceutical, biotechnology and medical device companies, academic institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies.