ICYMI OpenClinica recently published a case study about our work with the Imperial College of London, Zero Interruptions: Migrating 14 Mid-Study Clinical Trials in 16 Months.
In short, Imperial decided to modernize its electronic data capture (EDC) system to ease user burden, reduce training and data management challenges, streamline processes, and decrease costs. Historically, organizations like Imperial have opted to maintain active studies in the existing EDC system and initiate new studies in the new one.
Imperial, however, did not want to bear the added expense and administrative burden associated with maintaining multiple EDCs for its long-term ongoing studies. That’s why Imperial and OpenClinica embarked on a comprehensive mid-study data migration project in 2022.
Sixteen months later, I am proud to share that the results are in:
OpenClinica successfully migrated to a new EDC platform all of the data in 14 active studies – with 1,700+ patients and 150,000+ forms – for one of the world’s leading research organizations.
As Amanda Bravery, Head of Clinical Data Operations, noted:
OpenClinica is as passionate and as invested in Imperial’s success as we are. 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.”
Lessons Learned: Mid-Study Data Migrations and Managing Clinical Trial Changes
More broadly, mid-study data migrations such as the 16 we did with the Imperial College of London are a complex form of managing clinical trial changes.
During OpenClinica’s 16 months of work migrating Imperial’s data, a comparable project to migrate five active studies within a six-month period for a Top 25 biopharma company, and our work managing clinical trial changes for 15+ years, we have learned important lessons:
- Start by identifying each stakeholder, their role, and what they need.
- Work with stakeholders early to understand their requirements and practice frequent communication.
- Make a list of risks that could impact each stakeholder and assess it periodically.
- To manage clinical trials changes in the form of technology updates,
- Request and ensure you receive sufficient advance notice of software updates, with the appropriate level of details to properly assess impact and prepare for change.
- Understand which new features you must initiate (via a publishing workflow) vs. those initiated by the vendor that will automatically appear to end users.
- Request a pre-release sandbox environment for independent exploration and early testing with your specific study design.
- An integral part of the preparation for a data migration is a readiness checklist that covers testing & validation, data targets, documentation needs and more. To view OpenClinica’s checklist, visit: [add URL for case study landing page once it’s published]
- Dedicated teams and workflows increase efficiency.
- Data migrations of active studies are a marathon, not a sprint.
- Since no two studies are built exactly the same way, be comfortable flexing your plans.
- Expect the unexpected and be prepared to think outside the box for new solutions.
- Any challenge can be overcome with the right mindset.
To learn more, I encourage you to download: