Claiming that Trident will “fundamentally change” the interactive voice response/interactive web response (IVR/IWR) market, Mark Weinstein, CEO of BioClinica, told Outsourcing-Pharma, “The design, setup and conduct of all studies, simple to complex, can be changed by using this platform.”
Writing development specifications, programming and validating a new data management system for each clinical trial conducted can be both time consuming and costly, he said, but BioClinica’s web-based system provides a place to report and organise data for trials with ease.
“There are many IVR/IWR products on the market,” said Weinstein, adding, “what they do compared with Trident is similar, but how they do it is not.” One such difference between traditional IWRs and Trident is its ability to allow researchers to configure and modify studies, without having to custom program each new trial.
Furthermore, while most clinical studies average eight to twelve weeks to be built and deployed, Weinstein claims Trident can see a study completed in one to two weeks with less time spent configuring and programming, and potential reductions in time spent testing and validating a study.
“Historically, planning and forecasting has been part art and part science,” said Weinstein. “It’s often done on spreadsheets and often separately from the group and the systems responsible for managing clinical supplies.”
Fully integrates with BioClinica ‘Optimizer’
With this in mind, Trident integrates with all of BioClinica’s product offerings, in particular, “Optimizer,” a clinical supply simulation and visualisation package. Combining the two technologies allows researchers access to a 360 degree view of their study that uses real-time performance data to update forecasts based on actual data.
Trident software was designed by Tourtellotte Solutions, a firm BioClinica acquired in September 2009, who earlier developed an IVR system that has been used to support 300 trials, including 150 that are currently active and supported by BioClinica.
Though this product - part of its Express EDC solution - has been used for many studies, Weinstein said, “With Trident, we have a game-changing solution with clear benefits for every pharmaceutical biotech and device company, from the virtual sized to the largest.”
The commercial clinical IVR/IWR market has an estimated worth of $300m annually; a figure Weinstein believes can only grow as the trial management technology “can be used for virtually every clinical trial, so the potential demand is strong.”
Describing the software as “a small piece of the total puzzle” to make clinical research more efficient, he feels that “implementing Trident is a no-brainer to substantially improve the efficacy of this area for clinical research.”