Maximize IRT Performance
(Research Triangle Park, NC; July 7, 2015) – As the largest Interactive Response Technology (IRT) specialist in the world, Cenduit has extensive experience in the medical device study realm. A joint venture between Quintiles and Thermo Fisher Scientific, Cenduit shares its insights on the unique needs of medical device clinical trials and the important role IRT plays in supporting a successful trial.
“When selecting partners for a medical device study, it’s important to consider the value and benefits of working with an IRT specialist in conjunction with the overall costs and complexities of the trial,” said Grant Dietrich, director of account management for Cenduit. “Medical device studies are often more costly and extensive in comparison to drug studies, but a custom IRT system designed to meet specific trial needs can help reduce costs in the long run.”
Below, Cenduit provides insight on the role of IRT systems and requirements for medical device studies from design to execution.
Considerations for Medical Device Studies
- When dealing with drug studies, sponsors are concerned about expiration of materials and accurately forecasting materials needs. Medical device trials add other layers of complexity.
- Medical device studies must consider a variety of factors in implementing IRT solutions, including unpredictable patient enrollment, critical device implantation and ad-hoc device changes due to size or inadvertent contamination.
- Due to differing regulatory oversight and standards, very detailed records on the history of the device are needed.
Tips to Establish an Effective IRT System
- Supply chain expertise is critical from an IRT partner to provide both the consultation and system that is necessary.
- IRT systems for medical device studies must remain nimble to account for trial complexities and the ever-changing schedule. Studies must establish a system that is created to serve its unique requirements in order to prevent delays in patient care.
- Consulting with an IRT specialist that can customize reporting tools ensures both the sponsor and sites are able to accurately track a device and provide consistent answers.
- Working with your IRT partner to pre-determine acceptable system functionality provides a level of structure for both the sponsor and sites.
- You can utilize a Drug Accountability and Returns Management (DARM) system to track device movement in medical device studies – saving time and money. At a standard level, the system allows sites to enter the device disposition, indicating the device being used, and account for those that need replacing.