In an Industry First, Veeva Migrates Study Portfolio of Top 20 Biopharmas to Vault EDC

Veeva Systems, a prominent player in cloud-based software for the global life sciences industry, has successfully migrated a significant portfolio of ongoing clinical studies for a top 20 biopharmaceutical company. This achievement marks a notable advancement in the field of clinical data management.

The migration involved transferring 25 active clinical studies from a traditional electronic data capture (EDC) system to Veeva's Vault EDC platform. This transition is particularly noteworthy due to the scale and complexity involved, including a large-scale study encompassing over 500 research sites and 7,000 patients. The completion of these migrations is not only a first for the industry but also demonstrates the potential for enhanced efficiency in clinical trial management.

Historically, life sciences companies have been hesitant to transition ongoing studies to new platforms, largely due to the technical complexities, intricate data models, and perceived risks associated with such moves. However, Veeva Vault EDC has addressed these concerns with its proprietary migration capabilities, offering a secure and minimally disruptive solution. This has been exemplified in the recent migration project involving the transfer of over 55 million data points and five million forms, executed with both safety and efficiency.

Drew Garty, Chief Technology Officer at Veeva Vault CDMS, emphasized the shift in perception and approach towards migrating studies. According to Garty, the successful implementation of Veeva Vault EDC in ongoing studies challenges the previous reluctance rooted in concerns over locked-down legacy systems and perceived risks. He highlighted that biopharmaceutical companies can now confidently transition their ongoing studies from legacy applications to Veeva Vault EDC. This approach not only reduces fees and drives standardization but also enhances the experience for research sites involved in these trials.

Vault EDC vs Legacy EDC

Vault Electronic Data Capture (EDC) stands out in the realm of clinical trial management for its comprehensive approach to data handling. During the initial phase of a study, Vault EDC enables the creation of patient forms, including detailed edit checks, without requiring custom programming. This capability significantly streamlines the study startup process. As the study progresses, the platform efficiently gathers all patient form data, local lab results, and medical coding. Integral to its design are robust quality control measures, such as querying, targeted source data verification (SDV), and monitoring protocol deviations. Notably, Vault EDC is equipped to handle protocol amendments without necessitating database downtime, a critical feature for maintaining study continuity.

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As the study reaches completion, Vault EDC's functionality extends to data lock and post-processing features. These include the creation of end-of-study media and the archiving of crucial data, ensuring a comprehensive and secure conclusion to the trial. This end-to-end capability demonstrates Vault EDC's role in modernizing and enhancing the efficiency of clinical trials. The platform's agility is further underscored by its proven value in complex studies, as evidenced by significantly faster study builds, the complete elimination of known custom functions, and a ninefold increase in the speed of implementing study changes.

Topics: Emerging Technologies