How Alcon Took Their Clinical Processes Digital and Improved Efficiency Across Teams

This video details Alcon's successful digital transformation journey in clinical operations, focusing on replacing outdated manual systems with modern, interconnected solutions powered by Veeva Vault. The core objective of this mission was to enhance efficiency, boost interconnectivity both internally and externally with clinical sites and vendors, and ultimately free up valuable time for teams to concentrate on product development and patient quality of life. Alcon achieved remarkable speed in their implementation, hitting major milestones months ahead of schedule, demonstrating a high degree of organizational commitment and effective partnership with Veeva.

A significant theme throughout the transformation was the rapid adoption and deployment of various Veeva Clinical Vaults. Alcon initially set a stretch goal to go live with the ClinOps Vault across six studies by the end of July 2020 but exceeded this goal by launching with 13 studies. By the end of October, they had over 100 studies integrated into the system. Furthermore, the implementation of the Clinical Data Management System (CDMS) was completed two months ahead of schedule, leading to a profound organizational transformation within the data management function. This shift involved empowering data managers to also develop the clinical databases, thereby eliminating the time-consuming specification (spec) process that previously required extensive iterations between two distinct skill sets.

The consolidation of information and systems proved critical to achieving these efficiency gains. Previously, teams had to search across multiple disparate systems, resulting in piecemeal information. By centralizing study creation, management, and document collection, Alcon gained clearer, real-time metrics on operational efficiency and bottleneck identification. This transparency extended to workload management, providing a clearer picture of resourcing and individual assignments. The most dramatic efficiency gain was observed in the electronic Trial Master File (eTMF) process. Alcon moved away from a cumbersome, multi-departmental workflow that required creating specific cover sheets, manual scanning, and uploading—a process that often resulted in lost documents or pages. The new eTMF system allows for instantaneous document upload and viewing, making the previous manual workload a "thing of the past."

Looking ahead, Alcon plans to maximize the time savings achieved by focusing on study execution and offering enhanced support to clinical sites. The saved hours are being leveraged to shorten startup tasks, particularly for newer sites unfamiliar with research protocols. Their future digital path includes exploring Veeva SiteVault Free and SiteConnect to further automate information sharing, improve collaboration, and accelerate trials. This focus aims to reduce the administrative burden on sites, such as the manual scanning, filing, and long-term storage of paper records (up to 25 years), by providing electronic solutions that negate the need for such extensive manual workloads.

Key Takeaways: • Accelerated Implementation Success: Alcon demonstrated exceptional speed in their digital rollout, exceeding their stretch goal for ClinOps Vault implementation by launching with 13 studies instead of the targeted six, and completing CDMS implementation two months ahead of schedule. • Organizational Transformation via Technology: The CDMS implementation facilitated a major shift in the Data Management organization, where data managers were cross-trained to also develop clinical databases, eliminating the need for a separate, iterative specification (spec) process between two distinct skill sets. • Elimination of Process Bottlenecks: Consolidating systems into the Veeva Vault platform eliminated the need to search across multiple disparate systems, centralizing study creation, management, and document collection for enhanced efficiency. • eTMF Efficiency Gains: The transition to electronic Trial Master File (eTMF) dramatically improved document management by replacing a complex, multi-departmental manual process (involving cover sheets, manual scanning, and uploading) with instantaneous digital uploads and viewing. • Data Transparency and Workload Management: Centralized systems provided clearer metrics on operational efficiency, transparently identifying bottlenecks and allowing management to gain a clearer picture of resourcing, workloads, and who is working on specific tasks. • Shift from Administration to Execution: The saved time resulting from automation and process elimination is being redirected to maximize study execution and provide greater attention to critical tasks, rather than administrative overhead. • Enhanced Site Support Strategy: Alcon is leveraging the time savings to offer more robust support to clinical sites, helping to shorten startup tasks and guide newer sites through research processes, thereby accelerating the overall trial timeline. • Future Automation Focus: The next phase of the digital journey involves leveraging tools like Veeva SiteVault Free and SiteConnect to automate information sharing and reduce the significant administrative burden (e.g., scanning, filing, and 25-year storage requirements) associated with paper records at clinical sites. • Cross-Team Efficiencies: Utilizing different Veeva Vaults (e.g., CDMS data flowing into Clinical Vault) created efficiencies by ensuring information transparency across various functions, including data management, trial leads, document managers, site monitors, biostats, medical safety, and clinical supply. • Adoption Driven by Transparency: The transparency created by having different functional teams access and use the centralized system was a key factor in driving system adoption across the organization.

Tools/Resources Mentioned:

• Veeva ClinOps Vault
• Veeva CDMS (Clinical Data Management System)
• Veeva eTMF (electronic Trial Master File)
• Veeva SiteVault Free
• Veeva SiteConnect

Key Concepts:

• Digital Transformation Mission: A strategic, large-scale effort to replace manual systems and processes with modern, digital ways of working to improve effectiveness and efficiency.
• Interconnectivity: The goal of boosting seamless data and process flow both within the organization and externally with clinical sites and vendors.
• Specification (Spec) Process Elimination: The organizational change that allowed data managers to take on database development responsibilities, removing the need for a separate, time-consuming documentation and iteration process between two different teams.
• Connected Studies: The concept of automating information sharing between the sponsor (Alcon) and the clinical sites using platforms like SiteConnect to accelerate collaboration and trials.