Mid-study data migrations are inherently complex, since any two electronic data capture (EDC) systems will have different ways of storing and structuring data, and different interfaces for adding, editing and reviewing the data. The complexity is why historically mid-study data migrations have been rare. Not so anymore.
Proven Process for Managing Clinical Trial Changes & Mid-Study Data Migrations
Integral to OpenClinica’s work managing clinical trial changes, we created and perfected a proven process for migrating ongoing studies onto our electronic data capture (EDC) platform. First, we used our extract, inform and import process to migrate five active studies within a six-month period for a Top 25 biopharma company.
Next, our expertise and our platform’s extensive data import capabilities led the Imperial College of London to choose OpenClinica to migrate 14 ongoing studies from its legacy system to our EDC. Imperial sought to modernize its EDC system to ease user burden, reduce training and data management challenges, streamline processes, and decrease costs.
Rather than bearing the added expense and administrative burden of maintaining two EDC systems, OpenClinica successfully migrated 14 active studies – with 1,700+ patients and 150,000+ forms – in 16 months, one week ahead of Imperial’s deadline.
In the words of Amanda Bravery, then Imperial College of London’s Head of Clinical Data Operations,
Given the thoroughness of their data migration process, I – and our site leaders – are confident that ALL of our study data was migrated during the seamless cutover. Just as importantly, OpenClinica minimized study staff disruptions and maintained regulatory compliance throughout the process.”
Download OpenClinica’s new case study to learn how: Imperial College London: Migrating Data Mid-Study – 14 Studies in 16 Months.
Why A Mid-Study Data Migration
Many OpenClinica customers use more than one EDC system. It often makes sense in the beginning, but over time, presents challenges in the form of user frustration, training and data management hurdles, and additional administrative burden and financial costs. Until recently, organizations were hesitant to do mid-study data migrations, meaning the only way to streamline the number of EDC systems for clinical trials was to wait until a given study completes and then roll off that EDC system.
Now, prestigious global research organizations like the Imperial College of London are choosing to migrate active studies to OpenClinica’s EDC, allowing them to improve their day-to-day operations, the user experience, and management of their vendor portfolio and associated costs.
Why Choose OpenClinica
OpenClinica has a deep understanding of the various nuances of the data migration process. We collaborate closely with our customers to step through each of the eight phases of the migration process:
- Plan
- Database Design
- Data Mapping
- Migration Script Development
- Script Validation and Sandbox Checks
- Test Migration
- Production Migration
- Final Report
As we did with Imperial, we work with our data migration clients to assess and identify ideal target studies, helping to evaluate existing documentation needs and uncovering training requirements. OpenClinica also leverages our experience to help to determine the right team members in client organizations, map the data elements to target and create customized scripts for each study while simultaneously conducting testing and validation exercises along the way to ensure quality and regulatory compliance.
OpenClinica also works closely with our clients to navigate the inherent challenges to mid-study data migrations. In the case of Imperial, we successfully mitigated a range of challenges, including:
- End of April 2023 deadline,
- Limited study offline time during migration,
- Resourcing and time differences,
- Multiple, different data structures across multiple studies,
- Batch vs staggered approach,
- Source data verification,
- Varying system functionalities that needed to be matched, and
- Unplanned resource changes.
For more insight into OpenClinica worked with Imperial to migrate 14 ongoing studies in 16 months, download the case study: Zero Disruptions: Migrating 14 Mid-Study Clinical Trials in 16 Months.