Case Study: SOLTI Streamlines Clinical Research with Flex Databases

By 2016, SOLTI recognized that their existing trial management processes – mainly based on Excel and manual Word documentation – were no longer sustainable. The organization faced:

• Fragmented data stored across multiple files

• Duplicate information and inconsistencies

• Manual reporting prone to errors

• Difficulty managing increasingly complex studies

To address this, SOLTI adopted its first CTMS. However, after a few years, they found the system inflexible and lacking in cross-sectional analytics, modern monitoring tools, and responsive support.

In late 2022, SOLTI selected Flex Databases as their new CTMS provider. The decision was based on several key criteria:

• Customizable cross-sectional reporting to analyze KPIs across hospitals and trials

• User-friendly monitoring tools

• Strong and responsive customer support

• Integration capabilities with other platforms such as CRF/ECF

• A partner-driven approach with shared ownership of challenges

Migrating from the previous CTMS was a significant undertaking. The project began in March 2023 and included:

• Data review and clean-up: deciding what to keep, discard, or redesign

• Field mapping and format configuration

• Template creation for trackers and reports

• Weekly coordination with the Flex Databases team

By March 2024, SOLTI had successfully:

• Migrated 1,500+ monitoring visits

• Migrated 50 projects

• Imported data for 6,000+ patients

The team met tight deadlines due to the expiration of the previous vendor’s contract and successfully trained all staff before the transition deadline.

SOLTI experienced a significant transformation in their day-to-day operations. Notable benefits included:

Flexibility & Customization

• Easily created new tracker templates and cross-sectional reports

• Personalized confirmation and follow-up letters with branded designs

• Customized report templates and dashboards

Efficiency & Usability

• Offline completion of monitoring reports with easy upload when reconnected

• Automated alerts for overdue tasks

• Easy-to-access training materials with tutorial videos

Data Quality & Insights

• Real-time dashboards and KPI analytics for informed decision-making

• Centralized and consistent data for operational efficiency

Customer Support

• Fast, solution-focused helpdesk support

• Close collaboration during onboarding and migration

Following the successful CTMS implementation, SOLTI began onboarding Flex Databases’ eTMF module. Benefits include:

• Seamless integration between CTMS and eTMF

• One-click filing of visit reports, letters, and regulatory packages

• Improved audit readiness and compliance (21 CFR Part 11, GCP, HIPAA)

• Streamlined collaboration among sponsors, monitors, and internal teams

SOLTI’s partnership with Flex Databases reflects the importance of flexible, responsive, and scalable technology in modern clinical research. With improved data management, team collaboration, and operational oversight, SOLTI is now better equipped to continue advancing breast cancer research across its expanding network.