Charlottesville, VA, San Francisco, CA, New York, NY and Paris, France (PRWEB) May 27, 2010
Building on their previous releases, openQ has released an expanded offering for managing Investigator Initiated Studies/ Trials (IIS/IIT). openIIS 2.5 provides a broad set of tools to manage the complete IIS lifecycle, from study submission and internal review, to study closeout.
openIIS is designed from the ground up to support regulatory compliance in an era of increasing federal scrutiny. Transparent customer business processes, through clearly documented and extensive audit trails, provide customers with complete access to decision criteria - including who reviewed the application, when they reviewed it, and why they made their decision. Expanded reporting functionally provides insight into studies, supporting critical areas such as financial controls.
While openIIS comes pre-configured with best practices gleaned from openQ’s industry experience, this doesn’t mean that customers are forced into a constrictive environment. The system also provides a configurable workflow engine to give customers the flexibility to configure the software to match their standard operating procedures.
“Despite its broad feature set and business process flexibility, we wanted to make openIIS easy to use,” said Matt Prentis, Director of Product Management at openQ. “Leveraging easily accessible portals for external investigators and internal users, along with submission wizards to guide investigators as they navigate the submission process help provide a smooth user experience. Additionally, key functionality to support multi-company sponsored grants simplifies even the more complex management tasks.”
openIIS is part of a broad portfolio of software and data offerings that openQ provides to Life Sciences companies. openQ provides solutions in KOL Management, Medical Affairs Programs, Grant Funding & Study Management, and Speaker Programs.
Based in Charlottesville, Virginia, openQ helps Life Sciences companies manage compliant business processes in their Marketing and Medical Affairs organizations. openQ’s solutions currently support compliance initiatives at 8 of the Top 10 Pharmaceutical and 3 of the Top 5 Medical Device Companies. For more information, visit openq.com.