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.