During the testing trials of Difluprednate, a drug designed to reduce inflammation following ocular surgery, Tampa, Fla.-based Sirion used data capture software company DSG’s platform to remotely monitor patient conditions. Sirion’s clinical research associates managed the data through the system, which led to fewer anomalous data points created by human error in observations.
The case was novel to the FDA, which had no protocol for an eSource data clinical trial, according to a news release. An FDA auditor was assigned to the trial to develop protocols throughout the process.
Malvern, Pa.-based DSG’s platform was linked to all the clinical trial sites through laptops provided by Sirion, which allowed for one program to link all the facilities. This allowed for faster processing because the clinicians did not have to independently verify the source of the data, according to the news release.
“We are always excited to see new applications complimenting [electronic data collection] and dramatically reducing resources required to perform a clinical trial,” said Tony Varano, CEO of DSG, in the news release. “Eliminating paper data review with eSource and now with risk-based monitoring are resource game changers for our industry.”
