Companies partner to reduce risk and time in design and execution of adaptive clinical trials for bio-tech and pharmaceutical companies
Horsham, UK/Oxford, UK | April 28, 2009, Cmed, the leading clinical research organization and technology development company, has entered into a partnership agreement with Tessella, the information technology and consulting services company selected by R&D, science and engineering leaders for business-critical assignments. Under the terms of the agreement, Tessella and Cmed will ensure interoperability of Timaeus, the Intelligent Data Acquisition and Management system (iDAM) with Tessella FATES™, Tessella’s fixed and adaptive trial execution system.
“With Timaeus, organizations have the ability to acquire, manage and report data in near real-time. This is particularly important for adaptive trials because it minimizes the delay in the availability of response data and therefore adaptation of the trial,” said Tom Parke, Head of Clinical Technologies at Tessella. Parke added, “The interoperability of two best of breed clinical trial products represents an important step in removing the operational complexity associated with adaptive clinical trials.”
Richard Young, Director of Business Development at Cmed said: “Tessella and Cmed have been collaborating for some time; not least of all through our Adaptive Trial Design symposium (February 2009). By entering into a partnership this will reinforce our capabilities, and provide unparalleled solutions for adaptive designs.” Young continues: “Tessella bring huge experience in the design, simulation and execution of adaptive trial designs and the interoperability of Tessella FATES and Timeaus enables bio-tech and pharma companies the ability to leverage this knowhow.”
Cmed is an eCRO, based in Horsham, UK, New Jersey, USA and Timisoara, Romania. Cmed was formed by Pharmaceutical industry executives and it uniquely combines full clinical research services with advanced clinical data capture and management technology, Timaeus, developed by Cmed’s own technology company. Timaeus is a sophisticated and complete electronic data capture and management system, the first such system enabling multiple types of data capture within a single trial (including paper, web eDC and an advanced wireless eDC appliance) with full data management capabilities. The eDC appliance is even capable of direct data capture from medical devices, e-source support etc.
Further information is available at www.cmedresearch.com
For decades, Tessella has been successfully delivering IT and consulting services to world leaders in R&D, science and engineering. Through the application of scientific methods and rigorous quality procedures, we enable 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.
In designing FATES, Tessella is helping the Pharmaceutical Industry revolutionize the drug development process through the use of adaptive trial designs. In many adaptive designs, a sophisticated statistical model needs to be applied regularly to the accumulating trial data and the need for certain adaptations assessed. FATES is designed to allow that statistical model to be seamlessly moved from the trial design environment to a trial execution environment. Once in the execution environment the model is integrated with the data feed from the eDC and its outputs integrated with the IVRS, Data Monitoring Committee and Study Logistics Team. The adaptation process is made robust, automated, auditable and scalable.
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