Accelerating Toward a New Era of Clinical Trials: On-Demand Fireside Chat with Celerion

This video provides an in-depth exploration of the digital transformation occurring within clinical trials, focusing specifically on optimizing the flow of information between sponsors, Contract Research Organizations (CROs), and clinical research sites. Hosted by Veeva Systems and featuring representatives from Celerion, a CRO that also operates its own Phase I clinical units, the discussion establishes that the industry is moving toward a "digitally connected clinical trial" environment, a shift dramatically accelerated by the operational necessities imposed by the COVID-19 pandemic. The core problem identified is the reliance on manual, disconnected methods—primarily email (cited by 68% of attendees) and paper—for exchanging critical documents and operational data, which leads to significant challenges in visibility, tracking, and reporting.

The speakers detail Celerion's implementation of the Veeva Clinical Network, including Veeva Vault Clinical (for CRO operations like eTMF and CTMS) and Veeva Site Vault (for site operations). Celerion’s dual role as both a CRO and an investigator site (conducting roughly 200 Phase I trials annually) provided a unique opportunity to test the efficiency of automated information exchange via Veeva Site Connect. A major success story involved the instantaneous sharing of critical regulatory documents, such as protocols and IRB approvals. Previously, these documents suffered from version control issues and delays when distributed manually; now, they are pushed directly from the CRO’s production vault to the site vault, ensuring all parties are working from the current, compliant version, which is paramount for maintaining protocol adherence in fast-moving Phase I studies.

The implementation yielded measurable improvements in efficiency and quality. The real-time transfer of documents and essential metadata from the site to the TMF drastically improved TMF quality and inspection readiness by reducing the time lag between document creation and filing. Furthermore, the adoption of electronic signatures was a significant win for investigators, allowing them to sign documents remotely within minutes, eliminating the administrative bottleneck associated with paper processes. The speakers stressed that the key to successful digital transformation is focusing on a "touch once" philosophy—collecting data correctly at the source and using automation to push it through the system—and allowing sites to maintain consistent internal workflows while leveraging connected technology for external collaboration. They advised organizations to start the transformation immediately, rather than waiting for a perfect, fully defined end state, as the technology and regulatory landscape are continuously evolving.

Key Takeaways:

• Information Exchange is the Primary Bottleneck: Clinical trials are hampered by the reliance on manual methods like email and paper for exchanging information between sites and sponsors/CROs, resulting in poor visibility, difficult tracking, and high administrative burden.
• Digital Connectivity is Crucial for Compliance: Utilizing systems like Veeva Site Connect to automate the flow of documents (protocols, amendments, ICFs) between the CRO’s eTMF and the site’s eISF ensures that sites always operate using the latest approved versions, thereby minimizing protocol deviations and improving regulatory compliance.
• Real-Time Data Flow Improves TMF Quality: Pushing documents and metadata from the site vault to the TMF in real-time drastically improves TMF quality and inspection readiness by eliminating the weeks-long lag often seen when documents are manually scanned and filed months after collection.
• Remote Monitoring was Accelerated by Necessity: The pandemic forced immediate adoption of remote monitoring and e-source solutions, proving that remote access is viable and necessary for maintaining client timelines (e.g., meeting database lock deadlines) even when physical travel is restricted.
• E-Signatures Drive Significant Efficiency: Electronic signatures are highly valued by investigators, enabling them to sign critical documents remotely and instantly, which speeds up regulatory processes and eliminates the administrative backlog of paper documents waiting for PI review.
• Focus on "Touch Once" Workflow: Organizations should pressure test their processes to ensure documents are collected correctly the first time and then automatically pushed through the system, avoiding manual re-handling, duplicate data entry, and subsequent downstream queries.
• Site-Centric Technology is Essential for Adoption: Technology adoption is maximized when the system used by the site (e.g., Site Vault) is designed to support their consistent, internal day-to-day operations, rather than forcing them to adapt to multiple, inconsistent sponsor-specific portals.
• Unified Visibility is Critical for Milestones: Disconnected systems often result in different functional groups (e.g., data management, clinic staff, monitoring) operating with varying database lock timelines, which can delay overall study reporting; centralized visibility into key milestones is necessary for efficient project management.
• Start the Transformation Now: The key advice for organizations is to begin the digital transformation journey immediately, focusing on early adopters and tackling implementation in phases, rather than waiting for a perfect, fully integrated solution, as the industry landscape is constantly changing.
• Hybrid Studies Pose Implementation Challenges: When transitioning to digital systems, organizations must decide whether to retroactively digitize older, paper-based "hybrid" studies or focus resources on ensuring new studies are fully digital from the outset.

Tools/Resources Mentioned

• Veeva Clinical Network: The foundational concept and suite of applications connecting all parties in a clinical trial.
• Veeva Site Vault: The application used by clinical research sites for managing their eISF and e-regulatory binder.
• Veeva Site Connect: The application facilitating the automated, seamless exchange of information between the CRO/Sponsor Vault Clinical and the Site Vault.
• Veeva Vault Clinical: The suite of applications used by sponsors and CROs, including CTMS and eTMF.
• e-Source Monitoring: The practice of remotely accessing and reviewing source data collected at the site.

Key Concepts

• Digitally Connected Clinical Trial: A model where technology links all stakeholders (sponsors, CROs, sites, patients) to enable automated, seamless information flow, replacing manual processes.
• Inspection Readiness: The continuous state of having complete, accurate, and organized TMF and ISF documentation, which is significantly improved by real-time document exchange and quality checks.
• Administrative Burden: The time and effort wasted on manual, low-value tasks like scanning, emailing, and tracking documents, which connected systems are designed to eliminate.