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Groundbreaking Clinical Trial Research on Genetic Basis of Children's Health Powered by Cloud Techno

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By Business Wirevia The Motley Fool

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Groundbreaking Clinical Trial Research on Genetic Basis of Children’s Health Powered by Cloud Technology from Medidata and Digital Infuzion

Translational Research Institute at Inova Utilizing Joint Solution to Support Unique Clinical Study of Infants and Their Genomic Profile

NEW YORK–(BUSINESS WIRE)– Inova Translational Medicine Institute, a not-for-profit research initiative bringing personalized medicine to the public, has chosen a joint solution by Medidata Solutions (NAS: MDSO) and Digital Infuzion to support a unique observational study involving the correlation between a child’s genetic profile, their development and their long-term health. Together, Medidata and Digital Infuzion will deliver a web-based portal and cloud technology for collecting patient data, reviewing study progress and providing subjects with access to surveys and study information.

In a unique combination of genomics and clinical research, Inova is studying 2,500 families to analyze and predict the relationship between genetics and childhood developmental issues. The study will follow the infants for the first 1,000 days, starting in utero, and identify any health and development issues. By comparing these with the genetic profile of each family (child, mother and father), Inova hopes to identify specific genomic information associated with the medical issues, ultimately leading to new treatment and prevention pathways.

  • “We needed not only a sophisticated research design, but also the appropriate technology in order to conduct this unique investigation of genetics and infant health,” said John Niederhuber, MD, Inova EVP, CEO of the Inova Translational Medicine Institute and former director of the National Cancer Institute. “The clinical technology from Medidata and Digital Infuzion, both companies with strong reputations for supporting life science research with innovation, will allow for the smooth collaboration of the research team as well as the full participation of the parents in this study.”

The joint solution will bring together Medidata Rave®—the industry-leading system for capturing, managing and reporting clinical research data—with Digital Infuzion’s N of 1™ Health Research Platform—a technology service that provides tools for physicians and other care team members to collect, monitor and report on data and medical knowledge related to observational research, chronic disease and patient outcomes. Through a computer single sign-on, researchers will enter data about subject health, monitor participants and track study progress. Participating parents will complete surveys every six months via the portal and will have access to study updates and a library of materials …read more

Source: FULL ARTICLE at DailyFinance

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Hanmi Selects the Medidata Clinical Cloud for Faster Data Capture and Better Operational Oversight o

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By Business Wirevia The Motley Fool

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Hanmi Selects the Medidata Clinical Cloud for Faster Data Capture and Better Operational Oversight of Clinical Trials

Korean Pharma Implements Medidata Rave for Improved Site Productivity and Enhanced Data Management

NEW YORK & SEOUL, South Korea–(BUSINESS WIRE)– The Medidata Solutions (NAS: MDSO) platform has been selected by Hanmi Pharmaceutical Co., Ltd., a leading Korean pharmaceutical company, to support data collection and management in Phase I and II oncology clinical trials. Following a recommendation from LSK Global PS, a Medidata Services Partner and Korean contract research organization (CRO) providing clinical trial services to Hanmi, the life science organization selected the industry-leading Medidata Rave® system for electronic data capture, management and reporting.

Hanmi’s choice of the Medidata Clinical Cloud™ supports the company’s wider initiative to improve workflows and productivity while developing new therapies. In particular, Hanmi anticipates that its use of Rave will enhance site productivity through real-time data entry in an intuitive user interface and will also help streamline trials through Rave’s timely reporting capabilities and smooth handling of mid-study protocol amendments.

  • “Hanmi’s commitment to efficiently providing new innovative drugs across a number of therapeutic areas is reinforced by their adoption of the Medidata Clinical Cloud,” said Glen de Vries, president, Medidata Solutions. “By tapping into the effectiveness of next generation technologies, Hanmi is showing its dedication to safely expedite R&D to help bring drugs to waiting patients faster.”

By implementing Rave, the company also anticipates that more timely access to data for analysis will support better trial oversight and more informed and earlier decision making. Additionally, Hanmi anticipates better study start-up through Rave’s reusable study assets and its standards-based integration framework that facilitates rapid integrations with other systems to enable data sharing.

  • “Medidata’s reputation for streamlining clinical trials and enhancing trial decision making was a major factor in our decision to select the Medidata platform,” said Jeewoong Son, senior vice president, Hanmi. “Medidata’s commitment to designing cloud-based solutions that enhance research team productivity through user-friendly interfaces will play a role in driving efficiencies in our drug development programs and reducing the total cost of our clinical development.”

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Source: FULL ARTICLE at DailyFinance

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Spanish Biotech PharmaMar Selects Medidata Clinical Cloud to Accelerate Trials for Marine-Based Onco

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Spanish Biotech PharmaMar Selects Medidata Clinical Cloud to Accelerate Trials for Marine-Based Oncology Drugs

Innovative Spanish Pharma Chooses Medidata Based on Site Preference and Support for Faster, Better Decision Making

NEW YORK & MADRID–(BUSINESS WIRE)– PharmaMar, a Spanish biopharmaceutical company, has selected Medidata Solutions (NAS: MDSO) for its industry-leading electronic data capture (EDC) and clinical data management (CDM), safety data capture and reporting, and medical coding solutions. A member of the Zeltia Group and a leader in the development of antitumor drugs of marine origin, PharmaMar said the company’s investment in the Medidata Clinical Cloud™ will efficiently streamline its clinical trial processes in its mission to deliver drugs that treat cancer and rare (“orphan”) diseases.

A midsize pharmaceutical company investing heavily in research and development, PharmaMar has the world’s largest marine organism library, with over 135,000 specimens, and owns over 1,800 patents issued or in process. To replace paper-based clinical trial processes, PharmaMar sought an EDC system that would be easy to use and streamline the availability of reliable trial data for analysis. Following a successful deployment of Medidata Rave® in 2012, PharmaMar decided to use Rave for all future trials. It also chose Medidata’s Safety Gateway and Medidata Coder® to swiftly capture and code safety data, and is evaluating other applications across the Medidata Clinical Cloud platform to help enhance trial efficiencies and decision making effectiveness.

  • “Our sites in Europe and the U.S. recommended Medidata for its ease of use. In implementing the Medidata Clinical Cloud we found that we had earlier access to reliable data to help us make decisions for optimal patient safety and patient experience,” said Dr. Arturo Soto, clinical development director at PharmaMar. “Medidata has proven to be a collaborative partner, working tirelessly with us to help us efficiently meet the challenges of our complex oncology clinical trials.”

PharmaMar required a system that was compliant with industry standards, particularly CDISC data models, for easy integrations and data sharing with its other systems. With its commitment to the Medidata’s standards-based platform, PharmaMar is now leveraging Medidata’s knowledge transfer program to quickly take technology management in-house.