Medidata trial data tech to benefit from regulatory demands, analyst

By Dan Stanton

- Last updated on GMT

Medidata's cloud-based system set to benefit from regulatory environment
Medidata's cloud-based system set to benefit from regulatory environment

Related tags Clinical trial

A favourable regulatory environment encouraged by the 21st Century Cures Act will help drive CRO demand for Medidata’s cloud-based technologies, according to a Citi analyst.

Medidata Solutions provides cloud-based software as a service (SaaS) technologies to help contract research organisations (CROs) and sponsors manage and analyse clinical data.

In July​, the firm reported record revenues and following a company presentation at the Citi Global Technology Conference last week, Citi analyst Garen Sarafian reiterated his ‘Buy’ rating based on opportunities for the company to grow its business further.

“Mr. de Vries [Medidata’s President and co-founder] does not expect sales to CROs to dip,”​ he wrote in a note. “We expect Medidata will continue to balance the value it creates CROs by allowing them to benefit from its platform without encroaching on traditional CRO services.”

He also noted the current regulatory environment is favourable for the firm’s growth. “The demand for more robust clinical trial data continues to grow,”​ he said, adding the recently passed 21st​ Century Cures Act“would encourage the FDA to rely more on biomarkers, benefitting Medidata’s data-driven business.”

“We think data will become increasingly important for new drug therapies to gain approval and commercial acceptance, a positive for Medidata.”

Walvax Deal

In related news, the firm has announced China-based Walvax Biotechnology has adopted its Medidata Rave platform for electronic data capture and management in a clinical trial of its vaccine candidate for pneumococcal conjugate.

“Pneumococcal infections—including pneumonia, blood infections and meningitis—can be extremely difficult to treat, making prevention through vaccination a critical component of patient care,”​ said Yi Zhang, Vice President, Walvax.

“We’re pleased to be using Medidata’s robust, globally-validated technology to bring greater speed and operational efficiencies to our pneumococcal conjugate vaccine trials, ultimately leading to a safe and effective way to ensure young children are protected from the devastating effects of pneumococcal diseases.”

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