Product Reengineering for Pharmaceutical Research Company
Datasential LLC (www.datasential.com) has introduced TrialOne TM , a uniquely affordable Internet-based solution for electronic clinical trials used in pharmaceutical research. TrialOne is a clinical data service that provides most of the features pharmaceutical researchers are looking for, plus new features such as remote patient data synchronization and the integration of vital signs monitoring, all within XML standard formats and in a particularly secure Internet environment. Moreover, TrialOne works on all computer platforms, including the many new portable computers that offer work process advantages for clinical research through handheld data synchronization. Datasential is introducing TrialOne at the Drug Information Association Workshop in Atlantic City on March 12, 2001.
Business Requirement
In the area of Clinical trials, the efficient collection and analysis of remote patient data with minimum cost and maximum security is of utmost importance. The current data-collection methods are outdated and inefficient. Some new methodologies being adopted by Electronic Data Capture (EDC) vendors assume that login names and passwords will do just fine in protecting business-critical clinical trial data. Alternatively, they go about using a VPN or other expensive networking solutions.
Thus, high price and complex contracting requirements in collecting clinical trials data, combined with a lack of security have stood in the way of rapid EDC adoption.
Solution Benefits
The TrialOne TM solution from Datasential designed and developed by Calsoft Labs consists of the integration of multiple cutting edge technologies to create a secure, cost effective and efficient online tool to collect and distribute Clinical trials data.
The Datasential dedicated server provides a means for accepting data from a variety of input sources. Independent or 3 rd party vendors can download IVR survey data securely to customized data structures on the Datasential servers. Laboratories can download reports in multiple formats to the central server. The data collection personnel can fill online forms using web browsers. Highly interactive and small footprint Jetforms on the hand-held devices like tablet PCs and Pocket PCs provide a quick and efficient way of collecting data electronically. This data can then be synchronized with the Datasential server, so that field data is quickly aggregated at a central location to run statistical reports and analysis. The online reports are flexible and can be used by the Certified Research Assistants (CRAs) to quickly analyze and summarize the Clinical Trial results. The use of a flexible data model, with an XML engine for data transfer and presentation, combined with the usage of digital certificates for secure access makes TrialOne TM from Datasential LLC, the system of choice for Clinical Trials Data management.
Technology Architecture
Datasential is a unique clinical trials data service. Taking the most advanced features of the Internet, including XML formatting and secure digital signature technology, Datasential delivers eCRF and EVM - Electronic Vital Signs Monitoring - on a wide variety of computer media: PCs, PDAs, phones, tablet computers and IVRS. The use of Jetforms on the handheld devices and for the online forms makes the data collection engine very flexible and efficient. Mobile computers with vital monitoring tests integrated with eCRFs or questionnaires help in the collection of data from tests like spirometry, oximetry, EKG, blood pressure and body temperature.