Pioneering Swiss Pharma Auris Medical Selects Medidata Clinical Cloud to Support Novel Tinnitus Rese


Pioneering Swiss Pharma Auris Medical Selects Medidata Clinical Cloud to Support Novel Tinnitus Research

Development-Stage Pharma Chooses Medidata Cloud Platform as "Gold Standard" in Support of Pivotal Clinical Trials

NEW YORK--(BUSINESS WIRE)-- Medidata Solutions' (NAS: MDSO) cloud platform has been selected by Auris Medical, a Swiss pharmaceutical firm focused on developing novel therapies for inner ear disorders, to support the company's pivotal clinical trials for commercializing its new therapies for tinnitus and acute hearing loss. Auris will be using the Medidata Clinical Cloud™ for randomization and trial supply management (RTSM), electronic data capture (EDC) and clinical data management (CDM) in the forthcoming Phase III program with AM-101.

A pioneer in the field of cochlear therapies, Auris Medical's choice of the unified Medidata Balance® (for RTSM) and Medidata Rave® (for EDC/CDM) offering reflects the specialty pharma's commitment to best-in-class technology in its development of therapies to prevent and treat hearing loss and tinnitus. Auris' treatments involve an innovative approach of local administration of drugs to the inner ear.

  • "The Medidata platform is considered a gold standard in the industry, and we're excited to partner with Medidata in our quest to bring relief to people suffering from tinnitus and other inner ear disorders," said Thomas Meyer, founder and managing director, Auris Medical. "As we conduct clinical trials in this new field of study, we require a solution that will be hassle-free for our sites but also provide rapid implementation, robust data management and study agility."

Because of the novelty of Auris' treatments, the company specifically sought technology that would be easy to learn and intuitive to use for clinicians participating in the study at private practices, hospitals, academic sites and regional hospitals. Through the unified Medidata Balance and Medidata Rave solution, Auris researchers will use a single interface for patient randomization, treatment dispensation, and data capture, management and reporting—activities that traditionally have required multiple, disparate systems. The Medidata Clinical Cloud solution also includes embedded eLearning, allowing the clinicians to easily learn the system and initiate trials quickly.

With Medidata's standards-based infrastructure, Auris can easily integrate the Medidata Cloud with other systems, including patient reporting and lab data systems, thereby reducing the need for manual data integration and significantly shortening study start-up times and data management cycles.

  • "We commend Auris Medical for being an innovator in developing treatments for patients suffering from inner ear disorders," said Glen de Vries, president of Medidata Solutions. "We're thrilled to work with Auris to help them tap into the power of our cloud-based platform to support the development of pioneering cochlear therapies."

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About Auris Medical

Auris Medical is a Swiss pharmaceutical company developing specific pharmaceutical compounds for the prevention or treatment of inner ear disorders, an area of great unmet medical need. Around the world, many million people are permanently suffering from severe hearing loss and tinnitus. Truly effective and safe treatments for these disorders are still lacking. The Company is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. For both compounds, Auris Medical demonstrated safety and proof of concept in Phase II clinical trials and will now take both programs into pivotal trials. The Company recently closed a $50.6 million Series C financing round with Sofinnova Ventures and Sofinnova Partners.

About Medidata Solutions

Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers' clinical trials. Medidata's advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

Geoff Curtis

KEYWORDS: United States Europe North America New York Switzerland


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