Despite their well-perceived advantages, the adaptive trials
are complex to design, require more upfront planning, and are often met with statistical, procedural, logistic and regulatory challenges.
Merging Phase I & Phase II Clinical Trials: Adaptive Trial
Pharma is looking across their entire R&D process for ways to improve outcomes and adaptive trial
designs are definitely in the mix, as we've seen an increase in the adoption of adaptive trials
since ISR last examined the topic in 2010.
Grant Stephen, CEO of Tessella, added, "We are honored that a leading global contract research organization such as PPD is using our FACTS software to expand its adaptive trial
Among the latest industry trends: adaptive trial
designs dominate development programs and healthcare reform is bolstering outcomes research activities; despite recent regulatory initiatives, biosimilar development for the U.
White Paper Showcase titled: "Implementation of Adaptive Clinical Trials" Vladimir Dragalin, PhD, Senior Vice President, Clinical Trial Innovation Strategies Mary Riggs, Senior Vice President, Global Operational Excellence Jim Box, MS, MBA, Senior Director, Data Management Aptiv Solutions will speak about adaptive trial
specific SOPs, processes and work practices, and will provide a demonstration of AptivAdvantage[TM] - our integrated EDC/Randomization, drug supply and adaptive design engine technology solution on June 26 from 1:30 PM - 3:00 PM
Aptiv Solutions is uniquely positioned to assist clients in addressing both of these changes and I look forward to further building our market presence as the leading provider of adaptive trial
design, execution and clinical trial services.
Aptiv Solutions, a biopharmaceutical and medical device development services company, and leader in adaptive clinical trial design, simulation and execution, announced today the latest release in its proprietary suite of adaptive trial
software: ADDPLAN([R]) 6.
There is also increased sponsor demand for adaptive trial
designs and biosimilar services.
In this collaboration, Aptiv Solutions has licensed the use of FACTS(TM), the adaptive trial
design software developed by Tessella and Berry Consultants for early phase clinical studies.
Ellis will lead project management efforts with a focus on practices and methodology for adaptive trial
implementation and execution.
We are delighted to welcome the seasoned group of medical device and diagnostic experts from MDCI to the company, as we continue to broaden our acumen in medical device and adaptive trial