Press release: Tessella and Berry Consultants launch new FACTS™ engine to cover needs of Personalized Medicine Clinical Trials
Leading clinical trial simulation tool adds Adaptive Indication and Population Finder (AIPF) engine for Enrichment Designs
Oxford, UK | Austin,Texas, US | 25 June 12, 2012. Tessella, the international provider of science powered technology and consulting services and Berry Consultants, leaders in the Bayesian approach to medical statistics announce the availability of a new trial design engine for their FACTS™ product.
The new FACTS™ AIPF design engine introduces support for a whole new family of trial types. It allows the specification and simulation of enrichment designs in a personalized medicine setting where a treatment is to be tested in a number of distinctly different diseases or population types. In this type of trial there are multiple possible settings in which the treatment is to be tested – these might be disease subtypes, patient sub-populations or even different but related diseases, such as different types of pain, inflammation or bacterial infection. It is likely to be of particular interest in oncology settings where there are pre-identified genomic or proteomic markers that identify groups that could be expected to respond differently – either respond differently to the treatment (because the drug targets the gene or its mutation) or have a different prognosis overall.
Scott Berry, President and Senior Statistical Scientist at Berry Consultants commented: “The new functionality and features in FACTS™ provide an amazing platform for trial design optimization. Personalized medicine is such a hot area and this tool allows for easy simulation of a wide range of powerful designs. It’s a big step forward for trial design.”
Tom Parke, Head of Clinical Trial Design at Tessella said: “The new trial designs available significantly increase the scope of studies that the tool can be used for. We believe that this will be particularly useful for those working in oncology and in particular allows trial designers to easily explore types of trial design that have never been used before.”
Tessella began its work in Clinical Trial Optimization over 10 years ago, and currently provides trial optimization services to 5 of the top 20 pharma companies. The goal of trial optimization is to explore design options by simulating the planned trial using the different designs over a range of scenarios. Studying the observed operating characteristics of the simulated trials gives much greater insight into the planned trial than conventional trial planning techniques.
FACTS™AIPF will be launched at DIA Annual Meeting on June 24-28th 2012 in Philadelphia, USA
Notes to the editor:
For decades, Tessella has been successfully delivering IT and consulting services to world leaders in R&D, science and engineering. We enable our clients in life sciences, energy, the public sector, and consumer industries to achieve a wide range of objectives, including, forecasting floods, developing fusion power, enhancing military sensor capability, improving drug discovery and development efficiency, and reducing risk to health and the environment in the extraction and production of oil and gas. With offices in Europe and North America, global companies rely on Tessella for business critical assignments.
For more information about FACTS™ visit our dedicated site on www.smarterclinicaltrials.com
About Berry Consultants
Don Berry is a key opinion leader in Bayesian biostatistics, cancer research and policy, and adaptive trial design. Professor Berry has long championed adaptive trials in clinical research. His vision became reality and adaptive designs have gained favor with pharmaceutical and device companies as well as regulatory agencies. To meet this demand, he started Berry Consultants with Scott Berry in 2000. Since then Berry Consultants has designed well over 100 unique adaptive trials for medical device, biotech, and pharmaceutical companies. Berry Consultants includes 9 full-time statistical scientists and a variety of other collaborators to precisely tailor adaptive designs for each unique company, breakthrough technology, and regulatory situation.
Further information is available at www.berryconsultants.com
Christina Tealdi | Senior PR Communications Manager
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