eClinForce.com already has developed software that helps companies recruit and enroll individuals in trials. Now, it is working with the University of Maryland, Baltimore to design an online program that creates and processes electronic case report forms — the forms on which all information submitted by trial participants is gathered.
“You can capture (the data) with no programming skills,” said company President Ben Vhanj.
New drugs are tested for safety and effectiveness during clinical trials, and the data help determine whether safety warnings should be added to the label. The data generated during clinical trials are submitted to the Food and Drug Administration for use in the agency's drug approval process.
There is currently no one piece of software that captures all data needed by the FDA to make a decision, Vhanj said. He said his new data module, along with eClinForce.com's enrollment and collection software, could fill this void.
Vhanj, who had worked in the health care industry before starting the company, said he hopes to launch the new software by year's end.
Last week, his company was awarded $75,000 in funding by the Maryland Technology Development Organization — known as TEDCO — to help him meet this goal.
TEDCO President and Chief Executive Officer Renee Winsky said the company was chosen through a competitive process because the state believed its software could be successful.
dfrancis@dcexaminer.com
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