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Medidata Solutions, Inc.  (MDSO)
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Medidata Solutions, Inc.

Business Description


Medidata is a global life sciences technology provider, dedicated to improving the way clinical research is designed, conducted, and analyzed. Our cloud-based platform of solutions and data analytics enables efficiency and quality throughout clinical development programs by accelerating processes, enhancing decision-making, minimizing operational risk, saving resources, and enabling transformational trial strategies.

Customers can utilize our entire platform or purchase individual solutions or products. We offer our technology on an enterprise or multi-study basis. Customers can also use our solutions on a single-study basis for a limited number of trials or to evaluate them prior to committing to a multi-study arrangement. Subscription and professional services represent approximately 85% and 15% of our business, respectively. Our business model provides us with a recurring revenue stream that we believe delivers greater revenue visibility than perpetual software licensing models.

The Medidata Clinical Cloud
Medidata's unified platform, pioneering analytics, and clinical technology expertise power the development of new therapies for nearly 1,000 pharmaceutical companies, biotech and medical device firms, academic medical centers and contract research organizations ("CROs") around the world. The Medidata Clinical Cloud connects patients, physicians, and life sciences professionals. Companies on the Medidata platform are individually and collaboratively reinventing the way research is done to create smarter, more precise treatments.

It Starts With Data Capture and Management
The Medidata Clinical Cloud already powers the clinical trials of the future, including numerous master protocols, platform studies, and even trials that use synthetic control patients. It seamlessly captures and integrates the abundance of data streams and biomarker measurements that today's targeted therapies demand, not only from clinics and labs, but also from sensors, apps, images, genomics, and real world evidence ("RWE"). By capturing and integrating such a wide array of study data, the Medidata Clinical Cloud also automates many of the most challenging data management workflows across randomization, supply, coding, and safety. It is now possible for patients to electronically consent, be randomized, and receive their first supply all on their first visit. Medical terms can be coded automatically with natural language processing and machine learning.

Rich Data Capture Leads to Pioneering Analytics
The Medidata Clinical Cloud is underpinned by the Medidata Enterprise Data Store ("MEDS"). This cross-sponsor data store of de-identified study data contains the scientific and operational data from over 13,000 studies, half a million site and sponsor interactions, and 3.8 million patients, which are aggregated and standardized in a variety of ways to supply data sets. These data sets power analytics and benchmarking visualizations that enable smarter decision making, resulting in reduced patient burden and increased patient enrollment and retention. In addition, predictive analytics and machine learning throughout the Medidata platform drive intelligent processes such as risk-based monitoring ("RBM") and automated genomic clustering. MEDS also addresses the growing challenge of patient scarcity; Medidata's synthetic control arm and synthetic control data solutions enable organizations to leverage historical controls from statistically similar indications and studies to reduce the need to recruit new control patients.


Pioneering Analytics Accelerate Trial Planning and Management
Clinical complexity is increasing the burden of managing and operationalizing clinical studies. Minimizing patient burden in protocol design while optimizing site selection, grants, and payments in trial planning is a critical success factor to trial execution. Medidata's study design optimization, site feasibility, site grants, and payments solutions use historical benchmarks and automation from MEDS to optimize patient burden, site selection, grants, and payments, leading to increased patient recruitment and retention rates.


Medidata also solves many of the biggest challenges in trial management. Medidata's strategic monitoring and clinical trial management system ("CTMS") solutions address regulatory requirements for RBM by combining anomaly detection with intelligent workflows to enable sponsors, CROs, and sites to confidently move away from 100% source document verification. Medidata's master data management means that the majority of the artifacts in an electronic trial master file ("eTMF") can be pre-populated from other sources.

   

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