Novel IT Platform Helps Novartis Gain Control of Clinical Imaging Data

Researchers at Novartis in Basel have developed a powerful new electronic data capture (EDC) hub for clinical data that has allowed its investigators to control data across multiple trials as never before, according to David Tuch, head of clinical imaging at the Novartis Institute for Biomedical Research, Switzerland. “This is a game changer for managing clinical trials at Novartis.”...

...This is where Baumann’s first open-source effort—called ImagEDC—comes in (See: http://code.google.com/p/imagedc/). It allows hospitals and academic core labs to load data, while the tool ensures that the data fit Novartis’ desired format. “It helps any academic partner,” says Baumann. “They don’t need to care about licensing restrictions.”

Not only is it open source and easy to submit data, but it has useful advantages regarding regulatory requirements. “If you’re dealing with clinical trial software, it must be installed and tested in compliance with GCP regulations,” explains Baumann.  “Open source enables CROs to integrate code with their own infrastructure. It’s much easier this way.”

Why would Novartis share this software and know-how with its competitors? “The main thinking is that, on the level of transporting images from point A to B, for every trial and hundreds of partners, this is not what we consider to be a competitive advantage,” says Baumann. It’s only later, when one starts to engage in quality checking and analyzing the data, that the business knowledge and competitive advantage comes into play...