Tessella and Berry Consultants have formed a strategic alliance to produce a powerful tool to help Biostatisticians to rapidly design, compare and simulate both fixed and adaptive trial designs.
This trial design software is called Tessella Berry Consultants FACTS™ and supports key steps in the design of a clinical trial.
Find out how an increasing number of organizations are benefiting from FACTS™. Find out more.
Wyeth accelerate adoption of Adaptive Clinical Trials with Tessella expertise
When Wyeth decided to adopt an Adaptive Clinical Trials methodology, it turned to Tessella to help build an extensible software environment that would enable its statistician and clinical teams to more easily develop, compare and evaluate different trial designs. The resulting Adaptive Design Explorer system has helped accelerate the adoption of adaptive trials at Wyeth, leading to reduced drug development costs and time to market. Download Pdf…
Applied systematically better clinical trial design can deliver even greater benefits to a company’s drug development process.
Tessella and Berry Consultants have more than ten-years of experience helping both pharmaceutical and bio-tech organizations achieve a range of goals at enterprise and trial level, across a variety of indications and a range of trial phases.
An adaptive Phase II trial may determine that subject enrolment can stop earlier than a traditional fixed length trial, or a trial with a fixed manually conducted interim. Stopping enrolment early can save considerable trial time and also money in reduced subject enrolment costs.
We have developed a spreadsheet to help you assess the possible impact of the approach on your trial and on your drug development program… Find out more.
Wyeth Pharmaceuticals reports a trial decision being made
5 months early and savings of $14 million in direct cost
(Drug Information Journal | Vol 43, Number 6 | November 2009 | pp 725 )
and a further trial being closed two months early with 180
fewer subjects used, saving $1.5 million
(BioResearch Compliance Report | July 1, 2007 | Pickett, Joseph).
Expert Opinion
On Demand Webinar: FDA guidance on adaptive design – what does it means for you?
In Feb 2010 the FDA issued a draft guidance for industry on “Adaptive Design Clinical Trials for Drugs and Biologics” (pdf). Join me in this on-demand webinar as I quiz adaptive trial gurus Prof Don Berry and Dr Scott Berry on the implications of the FDA Guidance. I will be getting answers to the key [...]
Webinar 8th June: FDA guidance on adaptive design – what does it means for you?
Register for our live webcast on Tuesday, 8 June 2010 08:00 (PDT) 11:00 (EDT) 16:00 (BST) 17:00 (CEST) Join me as I quiz adaptive trial gurus Prof Don Berry and Dr. Scott Berry on the implications of the recent FDA Guidance on Adaptive Design for Clinical Trials. I will be getting answers to the key questions [...]
The principal aim of an Oncology phase 1 trial is the identification of the Maximum Tolerated Dose (MTD). The majority of oncology phase 1 trials are run using a design called “3+3. Under this design, subjects are treated in cohorts of 3, and based on the number of dose limiting toxicities seen in that cohort, [...]
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