How to Increase Efficiency of Clinical Trials with Content Management

This video provides an in-depth exploration of how to increase the efficiency of clinical trials through effective content management. Presented by Manu Vora, VP of USDM Life Sciences' Enterprise Content Management (ECM) practice, and Aaron Northington, VP of their Clinical practice, the discussion establishes that proper content management is critical for the success of clinical trials, especially given that many trials exceed budget and timelines. The presentation covers a range of topics from foundational best practices and strategic ECM implementation to innovative technological solutions and structured vendor selection.

The speakers emphasize a pragmatic approach to content management, starting with simple, achievable goals and avoiding the pitfalls of over-customization. They highlight the transformative power of e-signatures and workflows in significantly reducing processing times and streamlining operations within and across business groups. Furthermore, the discussion delves into the importance of a holistic ECM strategy that considers not just technology, but also the people, processes, and content involved, ensuring that implementations are well-supported and aligned with organizational drivers.

The video also touches upon leveraging industry standards, such as the DIA reference model for eTMF, to accelerate deployments and avoid common mistakes. It explores innovative solutions, including the use of structured content for regulatory integration, advanced feasibility survey systems, and the strategic adoption of cloud computing for enhanced collaboration and efficiency across the life sciences ecosystem. The session concludes with a detailed framework for ECM vendor selection, stressing the need to understand the entire content value chain—from creation to disposition—before committing to a solution.

Key Takeaways:

• Criticality of Content Management in Clinical Trials: Effective content management is paramount for clinical trial success. Statistics show that 7% of trials are over budget and exceed original timelines, and 20% of investigators recruit 80% of subjects. Well-structured, easily accessible content can significantly reduce timelines and accelerate trials.
• Adopt a "Crawl, Walk, Run" Approach: When implementing clinical trial content solutions, start simple and avoid over-customization. Over-customizing systems leads to a high cost of ownership and makes future changes more challenging. Focus on establishing standard taxonomies and setting achievable goals, like having the first document in production by a set date.
• Leverage E-Signatures for Significant Time Savings: E-signatures are a critical tool for optimizing clinical trial processes. Implementing e-signatures can drastically reduce the time required to obtain approvals on documents (e.g., from 19-58 days to 3-4 days for clinical trial documents), impacting areas like informed consent, investigator agreements, and visit reports.
• Implement Workflows for Process Streamlining: Utilize workflows to automate and streamline processes within and across business groups. Examples include automating statistical programming approvals, quality reviews, or feasibility surveys for site startup, which can cut days, weeks, or even months off clinical trial timelines.
• Don't Reinvent the Wheel; Embrace Standards: Avoid starting from scratch when setting up content management systems. Leverage industry-recognized models like the DIA reference model for eTMF taxonomy. This approach can prevent costly, failed implementations and accelerate progress, as demonstrated by a CRO that reduced eTMF deployment from 15-18 months to 3 months by adopting the DIA model.
• Holistic ECM Strategy is Essential: A successful ECM implementation requires a comprehensive strategy that goes beyond just technology. It must consider the "people" (stakeholders, end-users, staffing, capabilities), "process" (policies, SOPs, work instructions, process remodeling workshops), and "content" (volume, governance, security, ownership) aspects to achieve efficient gains.
• Identify Key Drivers and Proactively Address Pain Points: Understand the internal drivers for ECM (e.g., employee productivity, commercialization, scalability) and leverage solution enablers (e.g., single source of content access, process redesign). Be prepared for common pain points like complex legacy architecture, high IT investment costs, security risks, and process bottlenecks due to compliance.
• Utilize Robust Project Management Tools: For complex ECM implementations, employ project governance models, baseline project timelines, and responsibility matrices (RACI) to ensure clear communication, alignment among numerous stakeholders (including external partners), and effective tracking of progress.
• Explore Innovative Clinical Content Solutions: Consider solutions that integrate structured clinical trial content with regulatory information management systems to standardize global regulatory processes and accelerate submissions. Implement sound systems for feasibility surveys to create a maintainable database of potential sites.
• Embrace Cloud Computing for Cross-Organizational Efficiency: Cloud capabilities offer a significant solution for streamlining business processes and resolving inefficiencies when working across multiple organizations (sponsors, CROs, vendors). This can enhance collaboration and accelerate clinical trials.
• Consider Specialized Cloud Solutions for Clinical Exchange: Tools like Box, when GxP compliant, can serve as a clinical study exchange platform, facilitating cross-functional and external file transfers. This increases efficiency in communications, expedites site startup document exchange, and speeds up data transfer.
• Understand the Content Value Chain for Vendor Selection: Before selecting an ECM vendor, thoroughly understand your content's entire value chain: creation (e.g., user ad-hoc, image capture, electronic forms), management (security, structure, review), operations (workflows, collaboration), retention (records management, archiving), and disposition.
• Implement a Structured Vendor Selection Approach: Avoid rushing into an RFP. First, develop a clear ECM strategy by conducting needs and internal technology assessments, mobilizing teams, and defining the case for change. Only then proceed to solution design, RFP administration, vendor demos, and questionnaires.
• Available GxP Compliant Cloud ECM Systems: Veeva is a leading compliant cloud solution in the life sciences space. Alfresco also offers cloud-based ECM. While platforms like Box and Dropbox provide cloud ECM, they are not currently GxP capable, but may be in the future.

Tools/Resources Mentioned:

• DIA reference model for eTMF (Electronic Trial Master File): A standardized model for managing clinical trial documents.
• Sprint methodology: A five-day process for solving big problems and testing new ideas, as described in Jake Knapp's book "Sprint: How to Solve Big Problems and Test New Ideas in Just Five Days."
• Box: Mentioned as a potential clinical study exchange platform for cross-functional and external file transfer (with a note on GxP compliance).
• Veeva: Highlighted as a leading compliant cloud ECM solution in the life sciences industry.
• Alfresco: Mentioned as a provider of cloud-based ECM solutions.
• SharePoint 365: Mentioned as a tool for external collaboration.
• Project governance charts, project timelines, responsibility matrices (RACI): Standard project management tools.

Key Concepts:

• ECM (Enterprise Content Management): A systematic approach to managing the lifecycle of information, from creation and storage to distribution and archiving, often within regulated environments.
• eTMF (Electronic Trial Master File): An electronic system designed to manage all essential documents of a clinical trial, ensuring compliance, accessibility, and auditability.
• GxP: A set of good practice regulations and guidelines (e.g., Good Clinical Practice, Good Manufacturing Practice) that ensure the quality, safety, and efficacy of products in regulated industries like life sciences.
• 21 CFR Part 11: Regulations from the U.S. Food and Drug Administration (FDA) that define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
• Content Value Chain: The complete lifecycle of content within an organization, encompassing its creation, management, use in business operations, retention, and eventual disposition.
• Dark Data: Data that is acquired, processed, and stored but not used for any further purpose, leading to inefficiencies and missed opportunities.

Examples/Case Studies:

• A nationally renowned Clinical Research Institute successfully implemented an e-signature pilot program, reducing the time to obtain signatures on clinical trial documents from a range of 19 to 58 days down to just 3 to 4 days.
• A large CRO (35,000 people) initially spent 15-18 months on an enterprise-wide eTMF implementation that failed due to over-customization and over-complication. After revamping their approach and adopting the DIA eTMF guidance, they successfully deployed the system in approximately three months.