Click here to close now.

SYS-CON MEDIA Authors: Carmen Gonzalez, Liz McMillan, Pat Romanski, Marty Puranik, Marco Meinardi

News Feed Item

Medidata and TransCelerate BioPharma Inc. Announce Joint Initiative

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 Following draft guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), TransCelerate released a position paper in June 2013 and an update in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:

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.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Even as cloud and managed services grow increasingly central to business strategy and performance, challenges remain. The biggest sticking point for companies seeking to capitalize on the cloud is data security. Keeping data safe is an issue in any computing environment, and it has been a focus since the earliest days of the cloud revolution. Understandably so: a lot can go wrong when you allow valuable information to live outside the firewall. Recent revelations about government snooping, along...
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures...
The Workspace-as-a-Service (WaaS) market will grow to $6.4B by 2018. In his session at 16th Cloud Expo, Seth Bostock, CEO of IndependenceIT, will begin by walking the audience through the evolution of Workspace as-a-Service, where it is now vs. where it going. To look beyond the desktop we must understand exactly what WaaS is, who the users are, and where it is going in the future. IT departments, ISVs and service providers must look to workflow and automation capabilities to adapt to growing ...
Business and IT leaders today need better application delivery capabilities to support critical new innovation. But how often do you hear objections to improving application delivery like, “I can harden it against attack, but not on this timeline”; “I can make it better, but it will cost more”; “I can deliver faster, but not with these specs”; or “I can stay strong on cost control, but quality will suffer”? In the new application economy, these tradeoffs are no longer acceptable. Customers will ...
Red Hat has launched the Red Hat Cloud Innovation Practice, a new global team of experts that will assist companies with more quickly on-ramping to the cloud. They will do this by providing solutions and services such as validated designs with reference architectures and agile methodology consulting, training, and support. The Red Hat Cloud Innovation Practice is born out of the integration of technology and engineering expertise gained through the company’s 2014 acquisitions of leading Ceph s...
The free version of KEMP Technologies' LoadMaster™ application load balancer is now available for unlimited use, making it easy for IT developers and open source technology users to benefit from all the features of a full commercial-grade product at no cost. It can be downloaded at FreeLoadBalancer.com. Load balancing, security and traffic optimization are all key enablers for application performance and functionality. Without these, application services will not perform as expected or have the...
Hadoop as a Service (as offered by handful of niche vendors now) is a cloud computing solution that makes medium and large-scale data processing accessible, easy, fast and inexpensive. In his session at Big Data Expo, Kumar Ramamurthy, Vice President and Chief Technologist, EIM & Big Data, at Virtusa, will discuss how this is achieved by eliminating the operational challenges of running Hadoop, so one can focus on business growth. The fragmented Hadoop distribution world and various PaaS soluti...
As organizations shift toward IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection &E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his session at 16th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Partnerships, will disc...
VictorOps is making on-call suck less with the only collaborative alert management platform on the market. With easy on-call scheduling management, a real-time incident timeline that gives you contextual relevance around your alerts and powerful reporting features that make post-mortems more effective, VictorOps helps your IT/DevOps team solve problems faster.
Skytap Inc., has appointed David Frost as vice president of professional services. David joins Skytap from Deloitte Consulting where he served as Managing Director leading SAP, Cloud, and Advanced Technology Services. At Skytap, David will head the company's professional services organization, and spearhead a new consulting practice that will guide IT organizations through the adoption of DevOps best practices. David's appointment comes on the heels of Skytap's recent $35 million Series D fundin...
Cloud data governance was previously an avoided function when cloud deployments were relatively small. With the rapid adoption in public cloud – both rogue and sanctioned, it’s not uncommon to find regulated data dumped into public cloud and unprotected. This is why enterprises and cloud providers alike need to embrace a cloud data governance function and map policies, processes and technology controls accordingly. In her session at 15th Cloud Expo, Evelyn de Souza, Data Privacy and Compliance...
Platform-as-a-Service (PaaS) is a technology designed to make DevOps easier and allow developers to focus on application development. The PaaS takes care of provisioning, scaling, HA, and other cloud management aspects. Apache Stratos is a PaaS codebase developed in Apache and designed to create a highly productive developer environment while also supporting powerful deployment options. Integration with the Docker platform, CoreOS Linux distribution, and Kubernetes container management system ...
Skeuomorphism usually means retaining existing design cues in something new that doesn’t actually need them. However, the concept of skeuomorphism can be thought of as relating more broadly to applying existing patterns to new technologies that, in fact, cry out for new approaches. In his session at DevOps Summit, Gordon Haff, Senior Cloud Strategy Marketing and Evangelism Manager at Red Hat, will discuss why containers should be paired with new architectural practices such as microservices ra...
Roberto Medrano, Executive Vice President at SOA Software, had reached 30,000 page views on his home page - http://RobertoMedrano.SYS-CON.com/ - on the SYS-CON family of online magazines, which includes Cloud Computing Journal, Internet of Things Journal, Big Data Journal, and SOA World Magazine. He is a recognized executive in the information technology fields of SOA, internet security, governance, and compliance. He has extensive experience with both start-ups and large companies, having been ...
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. In his session at 15th Cloud Expo, Michael Meiner, an Engineering Director at Oracle, Corporation, will analyze a range of cloud offerings (IaaS, PaaS, SaaS) and discuss the benefits/challenges of migrating to each of...