|By Business Wire||
|May 20, 2014 08:32 AM EDT||
Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that it is partnering with TransCelerate BioPharma Inc. ("TransCelerate") on a project designed to inform the nonprofit organization’s continued efforts to modernize and streamline the way clinical trials are conducted and monitored worldwide.
Leveraging the robust operational data available through the Medidata Clinical Cloud™, Medidata is providing metrics and analytics to help TransCelerate answer important questions posed by the industry regarding the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites. Specifically, the analysis will more rigorously assess the relative contribution of source document verification (SDV) to overall clinical data quality. The findings will be analyzed with the intent of publishing the results in a paper co-authored by TransCelerate and Medidata.
“By leveraging Medidata’s expertise and breadth of clinical trial data, we will be able to provide further evidence to support the approach TransCelerate outlined for high-quality risk-based monitoring of clinical trials,” said Rehbar Tayyabkhan, RBM project lead for TransCelerate.
The largest initiative of its kind dedicated to improving drug development, TransCelerate—and member companies comprising most of the world’s leading, global life science R&D organizations—established five initial projects including the Risk Based Monitoring (RBM) initiative. Following draft guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), TransCelerate released a position paper in June 2013 and an update in early 2014 outlining an approach for RBM that can be adopted for any type, phase and stage of a clinical trial. The framework provided includes tools and triggers to help the industry identify and categorize risks. (For more information, please visit http://www.transceleratebiopharmainc.com.)
“Medidata shares TransCelerate’s commitment to modernizing clinical trials in order to speed up the delivery of safe, new therapies to patients,” said Glen de Vries, Medidata’s president. “We are thrilled to work with TransCelerate and delighted to help the consortium leverage our rich data and analytics capabilities.”
The analysis is being conducted leveraging Medidata’s comprehensive business analytics solution (Medidata Insights™), which comprises data—collected over the last five years—from over 7,000 clinical trials across the globe involving more than 120 sponsor organizations.
In addition to valuable benchmarking data and industry analytics, Medidata’s technology platform offers easy-to-use tools (Medidata TSDV and Medidata SQM) to support RBM. These capabilities are part of the broad set of cloud-based solutions Medidata has designed to help clients improve operational efficiencies, capture resource savings and enhance decision making throughout the trial lifecycle.
“Risk-based monitoring is clearly the direction for the future,” de Vries added. “Embracing this methodology and technology to support it will help sponsors and CROs improve project oversight, make smarter trial decisions, gain efficiencies across clinical operations and reduce costs, all while supporting patient safety, data integrity and compliance.”
Connect with Medidata:
- Read our blog, Geeks Talk Clinical
- Tweet this: .@Medidata and @TransCelerate announce joint initiative exploring key components of recommended #RBM methodology http://bit.ly/TmIiYJ
- Follow us on Twitter: @Medidata
- Find us on LinkedIn
About Medidata Solutions
Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud™ brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global clients, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Feb. 9, 2016 01:00 PM EST Reads: 182
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
Feb. 9, 2016 12:45 PM EST Reads: 224
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 9, 2016 12:30 PM EST Reads: 177
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
Feb. 9, 2016 12:15 PM EST Reads: 162
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 9, 2016 12:00 PM EST Reads: 143
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 9, 2016 11:45 AM EST
SYS-CON Events announced today that iDevices®, the preeminent brand in the connected home industry, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. iDevices, the preeminent brand in the connected home industry, has a growing line of HomeKit-enabled products available at the largest retailers worldwide. Through the “Designed with iDevices” co-development program and its custom-built IoT Cloud Infrastruc...
Feb. 9, 2016 11:45 AM EST
Predictive analytics tools monitor, report, and troubleshoot in order to make proactive decisions about the health, performance, and utilization of storage. Most enterprises combine cloud and on-premise storage, resulting in blended environments of physical, virtual, cloud, and other platforms, which justifies more sophisticated storage analytics. In his session at 18th Cloud Expo, Peter McCallum, Vice President of Datacenter Solutions at FalconStor, will discuss using predictive analytics to ...
Feb. 9, 2016 11:45 AM EST Reads: 384
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 9, 2016 11:45 AM EST Reads: 185
CIOs and those charged with running IT Operations are challenged to deliver secure, audited, and reliable compute environments for the applications and data for the business. Behind the scenes these tasks are often accomplished by following onerous time-consuming processes and often the management of these environments and processes will be outsourced to multiple IT service providers. In addition, the division of work is often siloed into traditional "towers" that are not well integrated for cro...
Feb. 9, 2016 11:30 AM EST Reads: 474
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
Feb. 9, 2016 11:30 AM EST Reads: 159
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 9, 2016 11:30 AM EST Reads: 398
Advances in technology and ubiquitous connectivity have made the utilization of a dispersed workforce more common. Whether that remote team is located across the street or country, management styles/ approaches will have to be adjusted to accommodate this new dynamic. In his session at 17th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., focused on the challenges of managing remote teams, providing real-world examples that demonstrate what works and what do...
Feb. 9, 2016 11:00 AM EST Reads: 251
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Feb. 9, 2016 10:45 AM EST Reads: 130
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Feb. 9, 2016 10:45 AM EST Reads: 186