October 3rd Installment to Focus on IVRS/IWRS, Randomization and Drug
Supply in Adaptive Clinical Trials
TORONTO, Sept. 19 /CNW/ - Medidata Solutions, Tessella and United
WHO: Hugh Levaux, Ph.D., Vice President of Product Strategy,
Tom Parke, Head of Clinical Trial Solutions, Tessella
Mike Borkowski, General Manager of Clinical Technologies
WHAT: "Enabling Adaptive Clinical Trials: IVRS/IWRS, Randomization
and Drug Supply"
As a part of the ongoing webinar series on adaptive clinical
trials sponsored by Medidata, Tessella and UBC, this fourth
webinar will explore the critical role of randomization,
subject management and drug supply in an adaptive trial.
Presenters will share detailed analysis and case studies of
the randomization process and will examine enrollment, data
collection, adaptive algorithm hosting, interim analyses, DMC
involvement, adaptive randomization, study blinding, and
supply management. For each of these topics, the webinar will
detail considerations and requirements to be addressed both
prior to and during the trial.
WHEN: Wednesday, October 3rd, 9-10 a.m. ET, 2-3 p.m. ET and 7-8 p.m.
WHERE: Participants are asked to register by 12 p.m. ET on September
28th at: www.enablingadaptivetrials.com
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.
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 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.
For further information:
For further information: Medidata Contact: Lois Paul & Partners, Susan
Lombardo, (781) 782-5767, Susan_Lombardo@lpp.com or Tessella Contact:
Tessella, Emily Turberville-Tully, +44(0)1235-555511,
Emily.Turberville-Tully@tessella.com or UBC Contact: United BioSource
Corporation, Tess Drahzal, (240) 644-0420, Tess.Drahzal@unitedbiosource.com