Background and Challenges
In the complex world of clinical research, data management plays a pivotal role in the success of any study. A cardiovascular device company (Company) faced a daunting challenge when their data, previously handled by a different contract research organization (CRO), was discovered to be incomplete and inconsistent with the protocol. Disorganized and incomplete, these data threatened the success of their study and future regulatory efforts. ActiVie was brought in to resolve several critical issues:
- The legacy data were disorganized and misaligned with the clinical investigation plan.
- The absence of a reliable electronic data capture (EDC) system caused inefficiencies, site frustration, and data entry errors.
- Tight timelines loomed as the next study required a robust data collection and management system.
Without immediate intervention, Company’s study operations were suffering significant setbacks, putting the study’s success at risk.
The Solution
ActiVie stepped in to take full control of the project, providing a comprehensive solution to modernize and streamline Company’s data collection and management processes:
- Data Import: The team meticulously imported thousands of mismanaged data fields into the updated system, ensuring data integrity.
- Updating Case Report Forms (CRFs): Old CRFs were made obsolete and new ones were created aligning with the protocol in just 2 weeks. These were integrated seamlessly into the trial operations and newly built EDC system.
- Building an System: Using the Viedoc platform, ActiVie developed a new, intuitive EDC system from scratch, making data entry easier and improving data quality.
This holistic approach not only addressed Company’s immediate concerns but also enhanced long-term operational efficiency.
Cost of Not Partnering Right
The stakes were high for Company. By not partnering with ActiVie at the outset:
- Significant study delays as data were never previously reviewed by the first CRO’s data management team. Data were reviewed by ActiVie and site coordinators and Monitors were in tight collaboration to update data appropriately.
- Significant cost in spending more than a year and half a million dollars on a company that developed poor study management documents and failed to deliver on trial oversight.
- Continued trial mismanagement, which threatened to erode trust from sites and reliability in the study’s findings.
Why ActiVie
ActiVie was the ideal partner for Company due to its unique blend of expertise in data management and the flexibility of the fractional scientist model:
- Precision and Expertise: ActiVie’s small, highly specialized team delivered precise results with minimal errors.
- Efficiency: The fractional scientist model allowed ActiVie to work quickly without the need for full-time staff, making the project cost-effective.
- Seamless Integration: ActiVie’s team built a user-friendly system that dramatically improved data accuracy and compliance with the clinical protocol.
The Outcomes
The partnership between ActiVie and Company yielded transformative results:
- A new EDC system was developed from scratch, enabling seamless data entry.
- Data errors were minimized, and legacy data were imported and reviewed for accuracy, resulting in 1300 queries issued and closed.
- Company’s study was brought back on track, with improved data integrity and faster query resolution.
- All forms, systems, and management documents were recreated in just a couple of months for less than half of the cost of the original CRO.
This successful partnership has set Company on a trajectory toward future clinical success.