MMS Holdings (MMS) – an award-winning, data-focused CRO – celebrated another successful collaboration with Oracle Health Sciences and a specialized Oncology pharmaceutical company. MMS will share their learnings with peers at the Society for Clinical Data Management (SCDM) annual meeting in Baltimore, Md.
This highly complex database build required several last-minute changes to the structure, resulting from recent industry discussions and learnings. The data collection team processed these new requirements and, due to changing sponsor needs, conducted multiple and parallel rounds of User Acceptance Testing (UAT) within compressed timeframes to deliver a high-quality database to the sponsor.
The success of this project can be attributed to multiple technical factors, along with a close working relationship with Oracle, including:- A thoughtful resource approach, allowing more tasks to be performed simultaneously
- Focused UAT, where portions of database review and testing occurred in parallel with the build of other functions
- Flexible project management, allowing for late-stage accommodations of data collection modules, staggered and compressed timelines, including trial capacity reduced to 2.5 weeks
- Leveraging the functionality of Oracle Health Sciences InForm, a comprehensive, integrated, open standards-based data capture and management platform, and Oracle's internal processes to speed the support ticket process
- Effective use of the Oracle Health Sciences Central Coding module, a web-based application that integrates with InForm to provide centralized coding stored in the clinical database
"Working with Oracle, we were able to create a collaborative environment for our data management experts to operate in, allowing them to build databases quicker, with the most recent industry guidance – astounding our own teams and sponsors alike," said Jim Bademian, Associate Director, Statistical Programming and Data Management, MMS, based in the Research Triangle Park region of North Carolina. "This was a very complex Oncology study, and our ability to act quickly and nimbly with multiple changes late in the process was critical to building this database on time."
High-complexity study design
This Oncology study included more than 70 unique case report forms (CRFs). Due to the nature of a niche therapeutic area, the MMS data management team was tasked with collecting clinical data from multiple sources and incorporating recent industry knowledge acquired by the sponsor. Since each subject had both donor and recipient data, the amount of data doubled and each had their own casebook within InForm. "
As a CRO, MMS has been one of the most inquisitive teams we have worked with – always seeking opportunities to bring the most efficient database structure to both ease data entry for the sites and improve data accuracy for their clients," said Ellen Lapriore, Global Vice President of Services and Consulting at Oracle Health Sciences. "While the MMS team has been working with InForm for years, their collaboration with our services team, and more specifically, bringing the full capabilities of Central Coding to their customers, has allowed for some of the most well-built clinical databases to date."
"Data planning and management, along with a desire to stay at the forefront of industry knowledge is what gets our global team excited to come to work every day," added Bademian.
