Virtify, Inc., a content and regulatory information management solutions provider for the life science industry, today announced Indiana University has signed an enterprise-level contract for its Clinical Trial Registration & Results (CTRR) disclosure software. Indiana University will utilize Virtify's CTRR to fulfill their regulatory obligations by disclosing their clinical trial information to the National Institute of Health's clinicaltrials.gov system. The system is funded and being implemented by the Indiana Clinical and Translational Sciences Institute (CTSI), a statewide partnership among IU, Purdue University and the University of Notre Dame funded by the National Institutes of Health.
"Indiana CTSI will partner with Virtify to help automate the complex clinical trial disclosure processes within the institution in order to fulfill its regulatory requirements. We're pleased to be working with Virtify to develop solutions that will help to reduce the effort it takes to publish the trial information to clinicaltrials.gov," said Richard Kovacs, M.D., associate dean for clinical research at the Indiana University School of Medicine and associate director of the Indiana CTSI.
The old paradigm for managing disclosure throughout the clinical trial process has changed. In the U.S. alone, submissions to www.clinicaltrials.gov are bound by 2,700 unique rules regarding clinical trial registration and 2,500 additional rules for results postings. Many academic and research organizations manage clinical trial disclosure manually, increasing compliance risk and costs.
Virtify's CTRR streamlines and automates the mandatory registration and clinical results disclosure obligations to the National Institute of Health and other registries. It provides a compliance view across all clinical studies, allowing for better reporting, proactive compliance and patient safety. Virtify CTRR is architected for change. Its unique XML Rules Injection technology is designed to provide the speed and flexibility needed to meet all global disclosure requirements while minimizing the overhead and complexity of change management. A detailed CTRR fact sheet is available at http://www.virtify.com/default/assets/File/VirtifyCTRR_Global_Clinical_Trial_Disclosure.pdf.
"Virtify is very pleased to work with Indiana University. Virtify CTRR will not only help improve compliance but will support the disclosure requirements for publishing to medical journals"² said Satish Tadikonda, president and CEO of Virtify, Inc "Virtify CTRR will eliminate duplicate data entry and will enable Indiana University to have a robust and seamless clinical trial disclosure process."