United Biosource Corporation, Medidata Solutions and Tessella to Present Webinar Series on Adaptive Clinical Trials
FOR IMMEDIATE RELEASE
United Biosource Corporation, Medidata Solutions and Tessella to
Present Webinar Series on Adaptive Clinical Trials
Industry Pioneers Combine Expertise to Deliver Insight on Critical Strategies
and Technologies for Enabling Adaptive Clinical Trials
BETHESDA, MD – June 13, 2007 – United BioSource Corporation (UBC), Medidata Solutions and Tessella today announced the first in a series of six educational webinars on adaptive clinical trials. The webinar series, entitled “Enabling Adaptive Clinical Trials,” will bring together key players from sponsors, services providers and regulatory authorities to provide real-life solutions to the complexities of planning and executing an adaptively designed clinical trial.
Successful execution of an adaptive clinical trial requires sponsors to change processes, implement technologies and apply strategic clinical expertise and scientific knowledge in entirely new ways. In these webinars, UBC, Medidata and Tessella will reveal the critical requirements and functions necessary to make an adaptively designed clinical trial an operational reality. Each company brings essential experience in key areas:
Tessella—Adaptive trials implementation services and award-winning enablement tools;
UBC—Trial design, investigator training, interactive voice/web response (IVR/IWR) technology solutions, and data management;
Medidata—Electronic data capture (EDC), management and reporting technology solutions.
“With the anticipated increase in regulatory acceptance, adaptive trial designs are at the forefront of drug development and offer sponsors the potential to shorten timelines, decrease costs and most importantly, improve patient safety,” said Tom Parke, Tessella’s Head of Clinical Trial Solutions. “While the benefits are potentially huge, adaptive clinical trials are still a challenge, and few have determined exactly how to implement them successfully.”
The first webinar, entitled “Operational Challenges and Strategic Planning,” will be held on July 11th. Participants can register at www.enablingadaptivetrials.com. This installment will discuss the business and regulatory factors accelerating the adoption of adaptive clinical trial designs. Participants will learn about the benefits associated with well-planned adaptive clinical trials when process, technology and know-how are successfully applied.
“A seamless transactional backbone—one that integrates trial simulations, EDC, clinical data management system (CDMS), IVRS/IWRS, electronic patient reported outcomes (ePRO), drug supply and the adaptive algorithm—provides a foundation on which adaptive clinical trials can be executed and scaled across an organization,” said Dr. Hugh Levaux, Medidata’s Vice President of Product Strategy. “Real-time information for decision-making and dynamic linking of operational and clinical data allows sponsors to quickly implement modifications in study design.”
“Even with the right regulatory environment and the right technology, sponsors who are looking to execute adaptive clinical trials need to devote time to planning for this change to the clinical process,” said Michael Borkowski, General Manager of Clinical Technologies at UBC. “By understanding how to prepare for this multi-disciplinary approach, sponsors will be able to fundamentally improve their processes and thereby realize the ROI adaptive trials can bring.”
Future installments of “Enabling Adaptive Clinical Trials” webinar series will be announced in the coming weeks.
About UBC
UBC is a global pharmaceutical services organization that combines deep scientific knowledge with broad execution expertise across the lifecycle continuum. Our focus is on generating real-world data to support the development and commercialization of medical products for emerging and established life science companies. We partner with our clients to offer services in scientific research and consulting, late stage development, post-approval registries and drug safety, data integration, clinical technologies, investigator services, patient recruiting and education. For more information, please visit www.unitedbiosource.com.
About Tessella
Since 1998, Tessella has been helping to drive innovation in drug development by enabling the deployment of Bayesian-based adaptive clinical trials. Tessella has implemented statistical models for phase 1 trials, phase 2 dose finding studies using Bayesian statistics, and phase 2/3 seamless designs. Tessella has supported these models by developing simulation and analysis tools, and by building and running the infrastructure to run the trials. For more information, please visit www.tessella.com/adaptivedesigns.
About Medidata Solutions Worldwide
Medidata Solutions helps the world’s leading pharmaceutical, biotechnology, medical device and research organizations maximize the value of their clinical research investments. Innovative process design, technology and services streamline clinical trials by providing early visibility to reliable clinical data—the lifeblood of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market—on six continents and in more than 80 countries. Medidata Solutions brings significant value to its broad client base with deep clinical experience and expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. For more information, please visit www.mdsol.com.
Contacts:
Tess Drahzal
United BioSource Corporation
240.644.0420
Tess.Drahzal@unitedbiosource.com
Susan Lombardo
Lois Paul & Partners
781.782.5767
Susan_Lombardo@lpp.com
Emily Turberville-Tully
Tessella
+44(0)1235.555511
Emily.Turberville-Tully@tessella.com