Meagan Medical Realizes Business Benefits with StudyManager Evolve

Challenge
Meagan Medical needed a simple, cost-effective clinical trial management system (CTMS) that featured electronic data capture (EDC) capabilities to ensure data quality.

Solution
StudyManager Evolve’s web-based CTMS and EDC features are seamlessly integrated and easy to use, allowing Meagan Medical to streamline processes and increase efficiencies, while also improving data entry compliance and quality.

Key benefits
- Lower overhead costs associated with simplified deployment across multiple sites
- Improved data entry compliance through an easy-to-use site interface
- Efficient management of queries and data corrections via centralized access to real-time data submissions
- Quality, ongoing technical support so the team can focus on managing the study

Meagan Medical is a clinical research and product development company with headquarters in Vancouver, WA. Established in March 2009 as the primary research component and sister company of RS Medical, Meagan Medical is dedicated to the vigorous pursuit of research and collaborative relationships in the areas of pain control and a variety of other neurological applications of electro stimulation therapy.

A key factor in the production of quality medical device products is the ability to efficiently manage a product’s clinical trial data. In the past, Meagan Medical had relied on an EDC system that was lacking in several key areas. Their previous system was cumbersome and not easy to use for a variety of reasons. The system:

• Lacked an integrated Clinical Trial Management System (CTMS), adding significant time to study management and requiring additional processes to be managed outside of the system.

• Was labor intensive. Time and resources were spent validating computers on which study data entry would take place as well as on data entry itself. Additional time and effort was necessary to issue and manage queries and verify data accuracy. As a result, the existing system required a lengthy and labor intensive process in order to produce clean, reliable data.

• Was not centralized or web-based, meaning Meagan Medical manually synchronized data from multiple sources and provided technical support at several locations including at both sites and the sponsors’ office.

“We needed a simple, easy-to-use system that would improve data entry compliance and data quality, while also maintaining happy site users,” said Kyle Hart, Clinical Data Manager at Meagan Medical.

Additionally, their system did not provide adequate reporting capabilities, did not allow for integration among the various sites, and lacked sufficient support. Accordingly, the team at Meagan Medical sought a way to improve management of clinical trial data and began a search for a more robust system.

The need for an integrated, cost-effective EDC solution
During Meagan Medical’s search, the company evaluated several CTMS and EDC systems. Hart says he learned about StudyManager’s Evolve CTMS with EDC, and found that it met all of their criteria.

“During our evaluation process, we found several CTMS and EDC systems that had far less functionality and that cost five times more than StudyManager. And some systems actually required that we get plug-ins for financials. We needed an integrated system, and we found that Evolve gave us the integration we needed.”

Evolve’s cross-functional, web-based platform is critical in allowing Meagan Medical to share data across 12 US.-based research sites.

“Our previous solution was not web-based, meaning we had to configure and validate every laptop for every study, which took a significant amount of time,” said Hart. “There were also times when we needed to customize a report, in which I had to write the code and make the changes myself, which took a significant amount of time. As a web-based system, we have found Evolve to be easy to deploy, which translates to lower overhead costs associated with the ease of maintenance for our organization.”

Support also was an issue for Meagan Medical.

“Our previous system had little to no technical support, meaning we had to take care of it all on our own, which was extremely time consuming. StudyManager provides ongoing support as part of its professional services group, which has made a big difference in our daily operations. If we have a need or an issue, we have experienced very short response times to our calls.”

Intuitive workflow streamlines data entry

“Before, when conducting paper studies, we had to manually enter data, which took on average about 25 hours per week,” said Hart. “In previous EDC studies, monitors had to wait until data was synchronized before issuing queries. Evolve provides real-time access to incoming data submissions, and we can query data instantly via the web so sites can turn around data corrections quickly. As a result, we now spend less than one hour per day supporting data entry.”

Quality, reliable data benefits clinical studies
Hart says that Evolve’s impact on Meagan Medical’s clinical studies has been a huge benefit.

“Evolve has helped us improve study management by ensuring we have reliable, quality data associated with our current study and for future studies The web-based feature is a key reason why. We have access to real-time data that we can pull from all of our systems, which has improved reporting,” said Hart.

“Our staff feels that study management is much easier, more intuitive, and that we have far fewer data entry errors, which gives us greater confidence in the clinical data.”

Jeffrey West is Director of Professional Services, and Natalie Brown is Project Manager, Professional Services, both at Meagan Medical.