There is increased interest in Adaptive Clinical Trials, with the FDA (the US Food and Drug Administration) announcing the preparation of guidance documents for their development. Adaptive Clinical Trials attempt to increase the efficiency of clinical trials by breaking out of the straightjacket of conventional experimental design, allowing pharmaceutical companies to make earlier decisions, lowering drug development costs and reducing the time taken to bring a drug to market. Building on our unique track record of supporting many of the top 10 pharmaceutical companies in this area, we continue to expand our services in this rapidly growing marketplace.

Since 1998, Tessella has been helping to drive innovation in drug development by enabling the deployment of 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. Such infrastructure has included central randomization, electronic data capture, and drug supply management. Tessella has also worked with pharmaceutical companies to enhance their own in-house systems so that they can support Adaptive Clinical Trials.

Webinar Series on Adaptive Clinical Trials

Tessella, with United BioSource Corporation and Medidata Solutions, recently delivered a series of six educational webinars on Adaptive Clinical Trials. The webinar series, entitled 'Enabling Adaptive Clinical Trials' brought together key players from sponsors, services providers and regulatory authorities to provide real-life solutions to the complexities of planning and executing an adaptively designed clinical trial. More than 800 individuals, from 250 organizations, participated in the webinars.

Webinar Topics:
July 2007, Operational Challenges and Strategic Planning
August 2007, Trial Design and Simulation
September 2007, Electronic Data Capture & Clinical Data Management
October 2007, IVRS/IWRS, Randomization and Drug Supply
November 2007, Business Process Reengineering and Integrations
January 2008, Regulatory Concern

To find out how Tessella might support your clinical trials, please email