A global leader in aerosol drug delivery technologies initiated a Phase 2 clinical trial to evaluate the efficacy of aerosolized surfactant therapy in preterm infants with Respiratory Distress Syndrome (RDS), with 3 weeks until target database lock.
In order to meet the tight timelines of the project while maintaining data quality, Veramed’s Data Management team delivered a carefully coordinated and proactive strategy. As a result, database lock was achieved ahead of schedule, supporting the client’s goals.
This trial was executed in parallel with the development of EDC and RTSM systems for the client’s Phase 3 program, adding operational complexity and strategic importance to the timeline.
The challenge
The client faced several operational and strategic hurdles – in particular, tight timelines in alignment with the client’s broader organizational push for operational efficiency. The initial EDC lock deadline was aggressive, requiring precise coordination across data management, site teams, and monitoring. With 3 weeks until target database lock, ensuring clean, query-free data posed a significant challenge, which was intensified by the simultaneous development of EDC and RTSM systems for an upcoming Phase 3 study.
The tight timeline demanded precise coordination across data management, site teams, and monitoring. Additional hurdles included maintaining high data quality within a compressed timeframe; and achieving seamless cross-functional alignment between the sponsor, clinical teams, and Veramed’s statistical and data management teams. These complexities required a strategic and agile approach to ensure success.
The solution
To meet the client’s ambitious timeline, Veramed’s Data Management team executed a meticulously coordinated strategy focused on proactive data handling and cross-functional collaboration.
Early and complete CRF entry laid the groundwork for continuous data cleaning cycles and real-time query resolution. Veramed worked closely with site teams and the client’s clinical operations group, holding a cross-functional database lock readiness meeting to ensure alignment. Strong relationships between the client and Veramed’s Data Management and Biostatistics teams enabled swift decision-making and approvals.
On the final day, Veramed overcame a technical issue in Medrio EDC by innovatively adjusting the bulk signature process, ensuring the database lock proceeded as planned. Additional efforts included real-time medical coding and streamlined SAE reconciliation, all contributing to a seamless and accelerated trial close.
The outcome
The result of Veramed’s strategic data management approach was a database lock, which was achieved an impressive 11 days ahead of schedule. This milestone not only validated the effectiveness of proactive planning and cross-functional collaboration but also reinforced the client’s internal messaging around speed and precision in clinical development.
The success demonstrated Veramed’s ability to deliver under pressure, aligning seamlessly with the client’s vision for operational excellence. It also strengthened the partnership between Veramed and the client, laying a solid foundation of trust and efficiency for future Phase 3 trials.
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