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news.To support growing pipeline of biologics for immune-related disorders
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NovImmune has selected Medidata’s Trial Planning product suite, to support the development of its pipeline of biologics for immune-related disorders.
NovImmune has utilized Medidata Grants Manager and CRO Contractor for a phase II type I diabetes trial, involving 160 patients and 75 sites in 12 countries. It is also incorporating Medidata Designer into its clinical development process.
To improve trial planning, streamline contract negotiation and control costs, NovImmune chose to leverage Medidata Grants Manager (a solution built on Medidata’s Picas database, enabling fast and accurate budget forecasting for clinical sites) and Medidata CRO Contractor (built on the Crocas database, providing a framework for budget negotiation with CROs).
NovImmune is also implementing Medidata Designer. It enables the standardized development of study protocols and capture of all protocol metadata in a structured, CDISC ODM certified XML file. It can be reused to rapidly set-up downstream systems, such as electronic data capture (EDC).
Tarek Sherif, CEO of Medidata, said: “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.
“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, he added.