Aptiv Solutions Announces the Latest Advance in Adaptive Clinical Trials
ADDPLAN 6 Software Introduced with Unique Offer
RESTON, VA — June 15, 2011— Aptiv Solutions, global provider of clinical research services, announced today the latest release of ADDPLAN, Adaptive Designs-Plans and Analysis®. ADDPLAN 6 is the first software package that incorporates multiple comparison procedures for multi-armed adaptive trials, including treatment selection designs, a flexible combination of clinical research phases, and population enrichment designs. Additionally, ADDPLAN 6 satisfies all requirements identified in the Food and Drug Administration’s recent “Guidance on Adaptive Design for Clinical Trials for Drugs and Biologics.”
“We believe so strongly in the role adaptive trials can play in speeding products to market that we are announcing today that a license for the ADDPLAN 6 base module, including features for adaptive trial redesign, simulations, and adaptive analysis, will be available at no charge,” stated Pat Donnelly, CEO and Chairman of Aptiv Solutions. “Adaptive clinical trials, when appropriately designed and implemented, can reduce development cycle time, improve decision making and get new therapies to market more quickly.”
Aptiv Solutions is the only clinical research organization to harness the power of adaptive clinical trial software supported by a fully-integrated in-house IT platform. Aptiv Solutions fully embraces the exciting new opportunities of adaptive clinical trials and has the experience to operationalize them into seamless clinical execution.
“Aptiv Solutions has been a leader in the development of advanced statistical software for the design and simulation of adaptive clinical trials for over a decade. With the launch of ADDPLAN 6, we continue to advance the state of the art in adaptive clinical trial software,” commented Reinhard Eisebitt, EVP of Aptiv Solutions Innovation Center.
The power of ADDPLAN 6 is now available in a suite of modules, including the base package, multi-arm comparison, and soon, a population enrichment module. Aptiv Solutions Innovation Center is staffed with world-class experts who can assist sponsors in the design and execution of adaptive clinical trials. For more information on licensing ADDPLAN, to see a demo or to have one of our experts contact you, please go towww.aptivsolutions.com and click on Adaptive Trials or visit our booth at DIA (Booth # 917).
About Aptiv Solutions
Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. The Company offers its clients an extensive portfolio of innovative services including adaptive clinical trials, early phase product strategy, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. We have over 700 professionals in North America, Europe, the Middle East, Japan, and Australia, and operate out of 22 offices in 17 countries. Visit our website at www.aptivsolutions.com.
‘ADDPLAN Adaptive Designs — Plans and Analyses’ was first released in 2002. Since then, interest in performing clinical trials with flexible (adaptive) designs has rapidly grown. The availability of a reliable, comprehensive, user-friendly and professionally validated statistical planning and analysis software package has never been so important before. Many recent developments in statistical theory were considered in the development process. ADDPLAN emphasizes adaptive group sequential test designs but also offers a much broader range of applicability. ADDPLAN 6 is fully validated and 21 CFR Part 11 compliant.
Contact: Lesley Keays
Phone: (508) 597-5775