United States

Profile: Medidata Solutions Inc (MDSO.O)

MDSO.O on Nasdaq

16 Aug 2019
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Medidata Solutions Inc. (Medidata), incorporated on April 12, 2000, is a provider of cloud-based solutions for life sciences. The Company provides cloud-based solutions for clinical research in life sciences, offering platform technology that focuses on the clinical development. The Medidata Clinical Cloud provides a platform of technology and data analytics solutions designed to optimize activities across clinical development. The Company's plan study addresses three areas to ensure optimal study design, grant development and negotiation, and investigator payments. Study Design Optimization enables customers to gain visibility into the impact of protocol elements on resource and trial endpoints. Grants Manager compares specific industry benchmarks and analytics, using industry's database of negotiated procedure costs, to support appropriate grants to investigator sites and automated negotiations with multiple investigator sites. Payments enables customers to establish a global investigator payment strategy and process to automate payment calculation, distribution and reporting, including tax and currency exchange calculations. These solutions help customers use resources through planning at the start of trial design and protocol development.

The Support Sites provides risk management, reduced source document verification (SDV), real-time monitoring and on-time payments. Medidata supports site with capabilities in the form of Risk Based Monitoring, On-site Monitoring, Site Quality Management and Targeted SDV. It engages patients to capture the voice of the patient in clinical studies using a mobile health (mHealth) solution, Medidata Patient Cloud. Medidata Patient Cloud enables sponsors to collect a dataset directly from the patient, accelerating patient-centric clinical research and improving the patient's clinical trial experience. Data is captured from wearable sensors and mobile applications using three regulatory-compliant technologies, such as SensorLink, AppConnect and ePRO along with services that support the life cycle of a mHealth trial.

Conduct Study includes solutions for data capture and study management throughout the clinical trial research process. Data capture is centered on electronic data capture (EDC) and management system solution, Medidata RaveX. It provides a globally-accessible and intuitive user interface to facilitate the capture and cleaning of data from investigative sites, is designed for compliance with regulatory requirements, and supports electronic signatures. As part of Medidata's platform, it links to tools for clinical supply tracking, safety system export and site management, including monitoring and payments. Medidata RaveX can process and manage data from multiple sources, such as Medical Imaging, through its unified integrations, application programming interfaces (APIs), and other data feeds, providing a single source of usable, patient data throughout the trial.

For study management, the Conduct Study suite offers capabilities that enable clinical teams to manage, monitor, control, integrate, and report operational and clinical data from patients and sites. Its specific functions include randomization and trial supply management (RTSM) through Balance, centralized medical coding through Coder, and safety data monitoring through Rave Safety Gateway.

Optimize Outcomes is designed to surface a range of embedded operational data across the clinical process. The Medidata platform provides dashboards, interactive platforms, ad hoc and scheduled reporting, and interactive analytics to enhance customers' contextual decision-making and real-time operational adjustments. Products include Insights, Operational Performance Analytics (OPAL) Diagnostics, Trial Assurance, and Centralized Statistical Analysis (CSA). The Company develops its solutions on a base of technologies, including Java 2 Enterprise Edition (J2EE), Oracle, Microsoft.NET, Microsoft SQL Server, Business Objects, Ruby, Cassandra, MySQL and Chef. Its professional services' offerings include implementation services, sponsor enablement, strategic consulting, partner support, change management, and e-learning and training.

The Company competes with Oracle and Parexel Informatics.

Company Address

Medidata Solutions Inc

350 Hudson St Fl 9
NEW YORK   NY   10014-4535
P: +1212.9181800
F: +1212.9181818

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