Swiss success

Medidata makes important deals with two different Swiss pharma companies in a two-week period

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

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

As to why he thinks Medidata Rave will serve a company likeRoche 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 collaborativelythrough easy-to-learn, easy-to-use Web-based interfaces. Also, because Rave'sdata management tools are built directly into the EDC system, this broaden thecapabilities of the product compared to many EDC systems, by better enablingmanagement of mid-study changes and providing a single platform that offersgreater efficiencies across multiple trials, multiple languages and multipledevelopment programs.

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

Roche reports that it will make use of Medidata Rave as thecore 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. Thecompany will begin with data collection for early stage, exploratory trials,but plans to ultimately encompass all phases of development, even up throughregistration, in the Medidata Rave effort. Roche had no further comment on thedeal, however.

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

"Specializing in both immunology and biologics, we'reworking within two of the fastest-growing areas of drug development," says JackBarbut, CEO of NovImmune. "Medidata's trial planning tools are key to ourability to prioritize and make critical decisions about our strategy formultiple clinical development programs—from size to locations to cost totiming—so that we're better equipped to manage and drive our pipeline."

NovImmune reportedly has already experienced the benefits ofMedidata's trial planning products in developing a task and activity plan,using CRO Contractor for an important study where a CRO was engaged. Thisfacilitated clearer understanding and consensus on tasks that needed to beconducted and aided in agreements on pricing, based on the CRO Contractorbenchmark costs.

In the ongoing effort to incorporate Medidata Designer,NovImmune is looking toward the ability to better standardize development ofstudy protocols and simultaneous capture of all protocol metadata in astructured, CDISC ODM certified XML file that can be reused to rapidly set-updownstream systems, such as EDC. As study protocols are developed, dataextracted from Grants Manager's PICAS repository will enable ongoing evaluationof trial cost and because of this, NovImmune will better be able to understandsites' costs of executing the protocol as it is being developed.

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

"NovImmune is working to meet a critical market need withits focus on biologics and immunology, and we are pleased to support itsefforts to improve the efficiency of its clinical development processes," saidMedidata's Sherif in a news release about the deal. "Medidata's trial planningproducts will enable NovImmune to continue to make informed and strategicdecisions about the therapies the company chooses to pursue and the varyingresources they will need to be successful in clinical development."

Jeffrey Bouley

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