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Swiss success
August 2009
by Jeffrey Bouley  |  Email the author


NEW YORK—If you hear any yodeling coming from New York City, it might be because Medidata Solutions, a global provider of hosted clinical development solutions, rang in the first day of July with the announcement that Basel, Switzerland-based Roche has selected Medidata Rave as its enterprise-wide electronic data capture (EDC) solution. That was followed two weeks later by the news that another Swiss company, NovImmune, had added Medidata's Trial Planning product suite its lineup, after already enjoying the fruits of Medidata's Grants Manager, CRO Contractor and designer products.

Looking at the Roche deal, Medidata CEO Tarek Sherif sees the willingness of Roche to invest in Medidata Rave on a global, enterprise-level basis as continuing evidence that drug developers are "looking for EDC solutions that not only offer access to data that will drive critical clinical research decisions across all phases, but also provide key efficiencies for all members of the research team."

As to why he thinks Medidata Rave will serve a company like Roche well, Sherif points to the product suite's usability, flexibility, scalability and accessibility. Medidata touts how well data managers, investigators, monitors and other clinical team members can use Rave to work collaboratively through easy-to-learn, easy-to-use Web-based interfaces. Also, because Rave's data management tools are built directly into the EDC system, this broaden the capabilities of the product compared to many EDC systems, by better enabling management of mid-study changes and providing a single platform that offers greater efficiencies across multiple trials, multiple languages and multiple development programs.

"Designed to more efficiently capture and manage data collection, Medidata Rave will enable global access of clinical trial data to all relevant Roche stakeholders, while also enhancing the company's overall drug development process," Medidata noted in the news release about the deal.

Roche reports that it will make use of Medidata Rave as the core enterprise-wide EDC system in its clinical trials as part of a phased, multi-year approach across its five disease biology areas, which are oncology, inflammation, virology, metabolism and central nervous system disorders. The company will begin with data collection for early stage, exploratory trials, but plans to ultimately encompass all phases of development, even up through registration, in the Medidata Rave effort. Roche had no further comment on the deal, however.

Swiss company NovImmune, for its part, has already used Medidata Grants Manager and CRO Contractor for a Phase II type I diabetes trial involving 160 patients and 75 sites in 12 countries, and it is in the process of incorporating Medidata Designer into its clinical development process. NovImmune selected Medidata's Trial Planning product suite to support the development of its biologics for immune-related disorders, and to "streamline all phases of clinical trials across [its] diverse portfolio."

"Specializing in both immunology and biologics, we're working within two of the fastest-growing areas of drug development," says Jack Barbut, CEO of 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 reportedly 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. This facilitated clearer understanding and consensus on tasks that needed to be conducted and aided in agreements on pricing, based on the CRO Contractor benchmark costs.

In the ongoing effort to incorporate Medidata Designer, NovImmune is looking toward the ability to better standardize 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 EDC. As study protocols are developed, data extracted from Grants Manager's PICAS repository will enable ongoing evaluation of trial cost and because of this, NovImmune will better be able to understand sites' costs of executing the protocol as it is being developed.

All of this is important to NovImmune because the company is currently working with seven compounds in several stages of development that are expected to have applications in multiple therapeutic areas. So, NovImmune's clinical trials range in size, complexity and patient population and often require engagement with multiple contract research organizations with varying and highly specialized areas of expertise.

"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 Medidata's Sherif in a news release about the deal. "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."

Code: E080904



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