Introduction:
In the evolving landscape of clinical data management, pharma companies are continually seeking more efficient ways to handle documentation requirements across different regions. Veeva's Clinical Vault has long been a cornerstone in this space, providing robust tools for managing Expected Document Lists (EDLs) and their association with milestones. However, the introduction of the EDL Refactoring feature brought with it certain complexities, especially for companies managing country-specific configurations.
Key Challenges with Previous EDL Management Approaches:
The earlier data model for EDL generation and milestone association introduced a range of issues:
Template Management Complexity: Managing multiple templates for EDLs and EDL items increased administrative overhead. Each unique country requirement often necessitated a separate template, complicating the overall template management process.
Lack of Country-Specific Customization: Prior to recent updates, accommodating country-specific documentation requirements often required extensive customization, which was cumbersome and time-consuming.
To address these issues, Veeva introduced the Override EDL Templates feature. This new feature is designed to streamline the management of EDLs by allowing greater flexibility in handling country-specific documentation requirements while maintaining a unified global standard.
What Are Override EDL Templates?
Override EDL Templates are a strategic enhancement that allows you to manage and customize EDLs efficiently. Here’s how it works:
Start with a Standard Template: Begin with a standard EDL template that encompasses global standards and non-country-specific elements.
Create Override Templates: For each country with specific documentation needs, create Override EDL Templates. These templates can include modifications or additions specific to that country.
Combine Global and Local Standards: The final EDL combines the global standards from the base EDL template with the country-specific elements from the Override EDL Templates.
Benefits of Implementing Override EDL Templates:
Reduced Template Overhead: By allowing for country-specific modifications without needing entirely separate templates, Override EDL Templates significantly reduce the complexity and volume of template management.
Enhanced Customization: Companies can maintain global standards while incorporating country-specific requirements efficiently, ensuring compliance with local regulations without redundant work.
Streamlined Processes: The ability to manage variations at the country level simplifies updates and maintenance, leading to more agile and responsive documentation processes.
Reduced Costs: Minimize the time and resources spent on template management and maintenance.
Use Case: A Pharma Company’s Success with Override EDL Templates
Background: A pharmaceutical company was previously managing a total of 520 generic EDL item templates—comprising 230 at the study level, 150 at the country level, and 140 at the site level. This setup also included country intelligence for 10 countries, resulting in significant administrative and management overhead.
Before EDL Refactoring and Override EDL Templates: The total number of EDL-related templates was calculated as follows:
Standard Templates: 520
Country-Specific Templates: 1500
Site-Specific Templates: 1400
Total Templates: 3420 approximately
After EDL Refactoring and Override EDL Templates: Post-refactoring with EDL Overrides, the company transitioned to a more streamlined approach:
Standard Templates: 520
Country Intelligence Override Templates: 50 per country × 10 countries = 500
Total Templates: 1020 approximately
Percentage Reduction in Overall Templates: The implementation of Override EDL Templates led to a reduction of approximately 70% in the total number of templates.
Wolvio Solutions: Your Partner in Transformation
At Wolvio Solutions, we understand the intricacies of clinical data management and the challenges faced by pharma companies in maintaining compliance across diverse regions. Our expertise in implementing and optimizing Veeva Vault solutions can help your organization transition smoothly to Refactored EDL Model with Override EDL Templates. We offer:
Consultation and Strategy Development: Tailoring a strategy that aligns with your specific needs and global standards.
Implementation Support: Assisting with the setup and integration of Override EDL Templates into your existing systems.
Ongoing Maintenance and Optimization: Ensuring that your EDL management process remains efficient and up-to-date with evolving requirements.
By leveraging our expertise, you can simplify your EDL management processes, enhance compliance, and focus on what you do best—advancing your clinical research and development goals.
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