How Vault CDMS Improves the Speed and Quality of Bioforum's Study Builds

This video provides an in-depth exploration of how Bioforum, a data-focused Contract Research Organization (CRO), leverages Veeva Vault CDMS to optimize the speed and quality of their clinical study builds. Tanya Duplessi, VP of Data Strategies and Solutions for Bioforum, establishes the company's primary focus on data quality from the beginning to the end of the trial lifecycle. She emphasizes that in the current challenging industry environment, having system flexibility and speed is hugely advantageous for achieving quicker timelines and implementing superior study designs.

A significant operational improvement detailed is the enhanced collaboration with sponsors. Vault CDMS allows Bioforum to share the system design visually with the customer, eliminating the outdated process of reviewing static documents like PDFs or printouts. This agile design system enables immediate visualization of proposed forms and structures, allowing sponsors to see changes instantly. This capability drastically reduces the number of draft versions required, helping the team "get it right from the first time" and accelerating the overall design and approval process.

The discussion also addresses the necessity of managing increasingly complex clinical trial designs. Duplessi argues that while trial designs are becoming more intricate, the underlying system build should not follow suit. Bioforum found that using the advanced build system within Vault CDMS, referred to as Studio, was critically important for streamlining efforts. A key differentiator and "big game changer" is the ability to utilize native system "rules" rather than relying on complex custom functions. Custom functions introduce complexity on top of complexity, which leads to significant time delays not only during the initial build but also during crucial validation processes and subsequent change management. By adopting a rule-based approach, Bioforum simplifies programming, making complex designs easier to manage and maintain.

Ultimately, the implementation of Veeva Vault CDMS allows Bioforum to focus their attention on the areas of the study that truly matter, rather than spending excessive time programming and validating bespoke code. This strategic shift toward leveraging standardized, rule-based automation ensures higher quality data management, faster study initiation, and more efficient operations for both the CRO and the sponsoring organization.

Key Takeaways: • Quality as the Primary Motto: For data-focused organizations like CROs, maintaining quality throughout the entire data lifecycle is paramount and should be the driving principle for system selection and operational strategy. • System Flexibility Drives Timelines: Achieving quicker trial timelines and implementing better study designs requires leveraging systems that inherently offer high degrees of speed and flexibility to adapt rapidly to evolving requirements. • Shift from Static Documents to Live Visualization: Eliminating the use of PDFs and printouts for design review in favor of live system visualization drastically improves collaboration with sponsors, allowing for immediate feedback and reducing ambiguity. • Adopt Agile Design for First-Time Accuracy: Utilizing an agile design system allows teams to show sponsors exactly how forms and structures will look and function, leading to fewer draft versions and ensuring the study build is accurate upon initial completion. • Decouple Trial Complexity from Build Complexity: The platform chosen must be robust enough to handle complex trial designs without requiring overly complex programming or custom development, streamlining the overall build effort. • Rules are Superior to Custom Functions: Relying on native system "rules" for logic and validation is a major game changer, as custom functions introduce significant complexity in programming, validation, and long-term maintenance, especially when changes are needed. • Minimize Validation Overhead: Custom functions are a major cause of time delays, not just during the initial build, but critically during the validation phase, which is essential for regulatory compliance. Utilizing platform rules mitigates this risk. • Focus Attention Strategically: By streamlining the basic programming and build efforts through advanced tools like Studio and rule-based logic, teams can reallocate their focus to the specialized, high-value areas of the study build. • Anticipate Future Complexity: Organizations must anticipate and prepare to manage increasingly complex trial designs in the future, making platforms that simplify complex builds a critical infrastructure investment.

Tools/Resources Mentioned:

• Veeva Vault CDMS (Clinical Data Management System)
• Studio (The advanced build system component within Veeva Vault CDMS)

Key Concepts:

• Data-Focused CRO: A Contract Research Organization specializing exclusively in data management, strategies, and solutions, emphasizing data quality throughout the clinical trial process.
• Agile Design System: A system capability that supports rapid, iterative design changes and immediate visual feedback, facilitating quicker alignment with sponsors and reducing the need for multiple draft versions.
• Rules vs. Custom Functions: A distinction highlighting the efficiency of leveraging standardized, configurable logic ("rules") within a platform versus developing bespoke code ("custom functions"), which increases programming complexity, validation burden, and maintenance costs.