In an unprecedented move within the life sciences industry, Veeva announced the successful migration of 25 clinical studies for a top 20 biopharmaceutical company to Veeva Vault EDC, marking a significant industry milestone. This transition included a large-scale study involving over 500 research sites and 7,000 patients, and migrating a total of more than 55 million data points and five million forms. The initiative to overcome the technical and risk challenges typically associated with migrating studies from legacy clinical trial EDC systems aims for enhanced standardization, cost reduction, and improved site experience during data migration. In this interview, we sit down with Pavel Burmenko, Strategy Lead, Veeva CDB, to discuss the challenges and planning to make the migration successful.
Moe: What prompted the decision to migrate clinical trial EDC data to Veeva Vault EDC, and what challenges did you face?
Pavel Burmenko: The primary drive behind migrating to Vault EDC was to enhance site user experience while upgrading to a system with superior performance and convenience. A major challenge was ensuring the seamless mapping of legacy clinical trial EDC databases, each with unique quirks, to the modern Vault EDC database. This required careful engineering and decision-making to maintain the integrity of the system and the data quality without disrupting the continuity that sites were accustomed to.
Moe: How were risks managed with this significant migration?
Pavel Burmenko: Addressing the inherent risks involves a multifaceted approach. A critical step was engaging an independent vendor to add a layer of scrutiny and ensure the migration’s quality. This was part of a broader quality control strategy that involved collaboration between the sponsor, Veeva, and the vendor. Regular, detailed meetings with stakeholders familiar with specific study nuances facilitated a proactive approach to risk management, ensuring every party maintained confidence throughout the process.
Moe: Could you elaborate on the technical innovations that made it possible to migrate such a substantial amount of data effectively?
Pavel Burmenko: A pivotal factor in our success was forming dedicated product and implementation teams within Veeva, explicitly tasked with developing migration-supportive features. One of the most impactful innovations was an automated mapping and transformation process utilizing metadata-driven, self-describing technology. This allowed for efficient data migration at scale and ensured the integrity of each data point through a meticulous, automated, yet customizable mapping process, addressing the unique characteristics of each study.
Moe: How did the collaborative effort with pharmaceutical companies play a role in ensuring the project’s success?
Pavel Burmenko: Our longstanding partnership with a leading pharmaceutical company, spanning over seven years, was instrumental. This deep-rooted collaboration fostered an environment of trust and mutual understanding, crucial for the delicate migration process. The pharmaceutical company’s engagement, guided by trust in Veeva’s capabilities, facilitated seamless decision-making and integration of new features. Dedicated personnel from both sides met regularly to discuss and navigate the project’s complexities, ensuring a tailored approach to each study’s requirements.
Moe: How has the migration to Veeva Vault EDC impacted ongoing and future clinical studies?
Pavel Burmenko: Post-migration, the most significant impact was the streamlining of the sponsor’s system landscape, transitioning from diverse, maintenance-heavy legacy systems to a singular, modern, and more efficient platform. This transition reduced the operational burden and positioned the sponsor to take full advantage of Veeva’s ongoing technological advancements. Challenges during the migration, such as coordinating complex timelines and ensuring comprehensive site training, emphasized the importance of detailed project management and clear communication.
Moe: Looking forward, how do Veeva’s innovation and partnership ethos shape the future of clinical data management?
Pavel Burmenko: Veeva’s commitment to innovation, coupled with a strong focus on collaborative partnerships, is redefining the standards for clinical data management. By facilitating seamless updates and integrations without downtime, even amid trials, Veeva addresses critical industry challenges. The deployment of Veeva Clinical Database (CDB) further exemplifies this, automating over 30% of traditional manual query processes, thereby significantly enhancing efficiency and data integrity across the board.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
