Webinar: Simplify Monitoring for CRAs

This webinar, hosted by Veeva Systems, focuses on "Simplify Monitoring for CRAs" by leveraging modern Clinical Trial Management Systems (CTMS) and offline monitoring capabilities. The session features experts from Veeva Vault CTMS, On The Move Software (a Veeva partner specializing in offline solutions), and a customer perspective from Illumina. The primary goal is to demonstrate how to quickly implement and deploy the CTMS application, specifically highlighting the benefits of offline functionality for Clinical Research Associates (CRAs) within the pharmaceutical and life sciences industries.

The webinar kicks off with Henry Galio from Veeva, who underscores the vital role of CRAs in clinical operations and the historical inefficiencies in their workflows. He presents data from "time and motion studies" spanning 20 years, revealing that CRAs spend a significant amount of time (e.g., 222 days on average per 1000 trip reports) using non-standard trackers like Word and Excel, or logging into disparate third-party applications, rather than a unified CTMS. This inefficiency stems from outdated software, poor connectivity, and a lack of intuitive tools. Galio emphasizes Veeva's commitment since 2016 to modernize CTMS, making it more efficient, intuitive, and enjoyable to use, especially in a post-COVID world where ease of use can impact talent retention. He highlights Veeva Vault CTMS's rapid adoption as a standard and introduces On The Move as a key partner in achieving seamless offline monitoring.

Duncan Scattergood from On The Move Software then provides a live demonstration of their product, which is a standard, out-of-the-box solution specifically built for Veeva CTMS. He explains that the application supports existing Veeva Vault configurations, is extensible to other Vault areas, and is primarily focused on Monitoring Visit Reports (MVRs). The core benefits showcased are its offline capability, allowing CRAs to work without internet connectivity (reducing reliance on manual trackers), and its mobile-first design for smaller devices, ensuring ease of use and guiding CRAs through the monitoring process. The demo illustrates features such as syncing monitoring events, intuitive navigation for answering questionnaires, adding comments (including a future voice-to-text feature), automatically creating follow-up items, and conditional questioning logic. The process culminates in a streamlined review and submission of the MVR back to Veeva Vault CTMS, appearing as if it were created directly in the standard interface.

Following the demo, Kelly Hazel from Illumina shares her company's experience with implementing Veeva Vault CTMS and On The Move. She recounts how the demand for offline capability arose early from CRAs and how their implementation journey, initially planned for early 2020, was impacted by project delays and the COVID-19 pandemic, which temporarily deprioritized the "traveling" use case. Despite these challenges, Illumina successfully went live with On The Move in December of the previous year, praising the seamless integration and the collaborative effort with the On The Move team. Kelly also details their approach to CRA training, which involved a phased, layered approach to gradually introduce Veeva CTMS and then On The Move, ensuring CRAs had a solid foundation. She emphasizes the importance of maintaining sync between Veeva Vault configurations and On The Move updates, especially given Veeva's three-times-a-year update cycle and Illumina's evolving business needs, including specific adaptations for COVID studies. The webinar concludes with a brief Q&A session, addressing technical aspects like data synchronization via the Veeva REST API and integration with Veeva CDMS.

Key Takeaways:

• Significant CRA Workflow Inefficiencies: Traditional CTMS systems and monitoring processes lead to substantial time waste for CRAs. Studies show CRAs spend an average of 222 days per 1000 trip reports using non-standard tools like Word/Excel trackers and logging into multiple third-party applications, highlighting a critical need for modernization and integration in clinical operations.
• Modern CTMS for Enhanced Efficiency: Veeva Vault CTMS aims to address these inefficiencies by providing a unified, cloud-based platform that connects to other applications, reduces clicks, and offers an intuitive user experience. The goal is to make monitoring tasks less onerous and more enjoyable for CRAs, improving overall operational efficiency.
• Offline Monitoring is Crucial for CRAs: The "On The Move" solution, integrated with Veeva Vault CTMS, provides essential offline capabilities. This allows CRAs to continue working on monitoring visit reports (MVRs) even in areas with poor internet connectivity or while traveling, directly reducing reliance on manual trackers and third-party apps.
• Mobile-First Design for Ease of Use: The On The Move application is designed for smaller devices (e.g., tablets, laptops) with a laser-light focus on ease of use. It guides CRAs through the monitoring process, making it simpler to get everything right the first time and reducing training overhead.
• Streamlined MVR Completion: The demo showcased how On The Move simplifies the creation and submission of MVRs, including answering questionnaires with single touches, adding comments (with a potential future voice-to-text feature), automatically generating follow-up items, and implementing conditional questioning logic to streamline the user flow.
• Seamless Data Synchronization: On The Move syncs data with Veeva Vault CTMS via the Veeva REST API, ensuring that monitoring events and completed reports are seamlessly transferred between the offline device and the main CTMS, appearing as if created directly in Veeva.
• Importance of IT Partnership in Implementation: Illumina's experience highlights the value of a strong partnership between business and IT departments for successful implementation. Addressing IT questions, compliance, timelines, and impacts collaboratively ensures smooth integration of new software like On The Move.
• Phased and Layered Training Approach: For new software adoption, especially for CRAs transitioning from older tools, a phased training approach is highly effective. Illumina successfully layered On The Move training on top of foundational Veeva CTMS training, allowing CRAs to adjust gradually and build proficiency.
• Continuous Configuration Management: Maintaining synchronization between Veeva Vault CTMS configurations and partner solutions like On The Move is critical. Given Veeva's frequent update cycles (three times a year) and evolving business needs, organizations must proactively manage configuration changes to ensure consistent functionality across all integrated systems.
• Veeva CTMS as an Industry Standard: Veeva Vault CTMS is rapidly becoming a standard in the industry, indicating a strong market presence and a platform that many life sciences companies are adopting for their clinical operations.
• Integration with Other Veeva Products: Veeva offers productized connectors, such as from Veeva CDMS (Clinical Data Management System) to Veeva Vault CTMS, allowing relevant data from EDC systems to flow into monitoring visit reports and then seamlessly to offline tools like On The Move.
• Impact of Global Events on Software Adoption: The COVID-19 pandemic significantly impacted Illumina's implementation timeline for On The Move, temporarily deprioritizing the "traveling" use case. However, the tool still proved valuable for CRAs working from home with inconsistent internet connectivity, demonstrating its versatility beyond its initial intended use.

Tools/Resources Mentioned:

• Veeva Vault CTMS: Clinical Trial Management System.
• On The Move Software: Partner solution providing offline capabilities for Veeva enterprise applications, specifically focused on Veeva Vault CTMS for monitoring visit reports.
• Veeva CDMS: Clinical Data Management System (mentioned in context of integration with CTMS).
• Veeva REST API: Used for data synchronization between On The Move and Veeva Vault CTMS.
• Microsoft Surface, MacBook, iPad, Phone: Examples of devices On The Move can run on.
• Word, Excel: Examples of non-standard trackers CRAs often use.

Key Concepts:

• CTMS (Clinical Trial Management System): A software system used to manage and track various aspects of clinical trials, including planning, execution, and reporting, crucial for pharmaceutical and life sciences companies.
• CRA (Clinical Research Associate): Professionals responsible for monitoring clinical trials, ensuring compliance with protocols, regulations, and data integrity at investigative sites.
• Offline Monitoring: The capability for CRAs to perform monitoring activities and complete reports on a device without continuous internet connectivity, with data syncing automatically once a connection is re-established.
• Monitoring Visit Report (MVR): A formal document prepared by a CRA after a site visit, detailing observations, findings, and follow-up actions related to the clinical trial, critical for compliance and oversight.
• Time and Motion Studies: A research methodology used to analyze and measure the time taken to perform tasks and identify inefficiencies in workflows, often applied to optimize operational processes.
• Conditional Questioning: A feature in questionnaires where subsequent questions appear or disappear based on the answer to a previous question, streamlining the user experience and reducing irrelevant data entry.
• Veeva Vault Platform: A cloud-based content and data management platform for the life sciences industry, serving as the foundation for various Veeva applications like CTMS and CDMS, ensuring a unified ecosystem.

Examples/Case Studies:

• Illumina's Implementation Journey: Kelly Hazel from Illumina shared their real-world experience implementing On The Move with Veeva Vault CTMS. This included detailing the challenges (project delays, pandemic impact), the critical importance of IT partnership, and their successful phased CRA training approach, providing practical insights into deploying such a solution in a life sciences company.
• 20 Years of Time and Motion Studies: Henry Galio referenced two decades of research on CRA workflows, providing a specific data point: 222 days spent on non-standard trackers per 1000 trip reports. This illustrates the historical inefficiency that modern CTMS solutions, like Veeva Vault CTMS with On The Move, aim to solve by streamlining processes and improving tool usability.