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.
Learn more about data management services at Data management and Biostatistics
About MMS Holdings
MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company was named Most Outstanding CRO in the 2019 Biotechnology Awards and Best Global CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
About Oracle Health Sciences
Oracle Health Sciences breaks down barriers and opens new pathways to unify people and processes to bring new drugs to market faster. As a leader in Life Sciences technology, Oracle Health Sciences is trusted by 29 of the top 30 pharma, 10 of the top 10 biotech and 10 of the top 10 CROs for managing clinical trials and pharmacovigilance around the globe.
Trademarks
Oracle and Java are registered trademarks of Oracle and/or its affiliates.
###