Clinical trial site monitoring is one of the most expensive components of clinical trials; on-site clinical research monitoring alone accounts for around 25 to 30% of the total trial expenses.1 A substantial portion of the clinical trial timeline involves inefficient Source Data Verification (SDV) and Source Data Review (SDR) activities, which can also consume a significant part of a monitoring budget and overall trial duration. The industry needs more efficient site monitoring processes to streamline clinical trials, reduce both time and costs, and ensure better accuracy.
Adaptive clinical trial site monitoring has emerged as a critical tool for sponsors and CROs seeking to optimize operations, save money, and enhance study effectiveness. The Site Profile & Oversight Tool (SPOT), an integral piece of the modern trial management puzzle, stands at the forefront of this movement, offering robust capabilities that take risk-based monitoring and risk mitigation to the next level for a more comprehensive clinical trial oversight plan.
Keep reading to discover the Site Profile & Oversight Tool (SPOT) from CluePoints.
The Role of Site Monitoring in Clinical Trials
Site monitoring in clinical trials is the process of overseeing the activities at investigational sites to ensure that:
- The rights, safety, and well-being of trial participants are protected
- The clinical trial data collected is accurate, complete, and verifiable from source documents
- The trial is conducted in compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements
What Is the Monitoring Process in Clinical Trials?
Traditionally, clinical trial site monitoring refers to the resource-intensive method of overseeing clinical trial sites, primarily through frequent, scheduled on-site visits by Clinical Research Associates (CRAs). The goal is to verify that the trial is conducted properly and that the data is accurate and complete. Key steps include:
- Site Initiation Visit (SIV): CRA travels to the site to train staff, review protocol, confirm documentation readiness, and ensure regulatory compliance before patient enrollment begins.
- Regular On-Site Monitoring Visits: Typically occur every 4–8 weeks, regardless of actual site risk or performance.
- Query Resolution: CRAs raise data queries and follow up during visits or by email/phone to resolve discrepancies.
- Monitoring Reports: After each visit, CRAs submit a detailed report including findings, issues, and required corrective actions.
- Close-Out Visit: Final review of documentation, regulatory files, and IP reconciliation to ensure everything is complete and ready for audit.
Clinical Research Associate (CRA) Monitoring
CRAs are responsible for ensuring that clinical studies are conducted in compliance with:
- Good Clinical Practice (GCP)
- Regulatory requirements (FDA, EMA, ICH, etc.)
- The clinical trial protocol
- Standard Operating Procedures (SOPs) of the Sponsor or CRO
CluePoints’ Next-Gen Site Profile & Oversight Tool (SPOT)
SPOT is a cutting-edge technology for adaptive clinical trial site monitoring. Developed through close collaboration with two established pharmaceutical clients, SPOT is a flexible, tech-agnostic tool containing all of the features and functionalities that both sponsors and CROs need to boost clinical trial efficiency, particularly when paired with a robust RBQM solution. SPOT has already gained recognition from the clinical R&D community as a finalist in the 2024 Citeline Awards, a sign of the industry’s excitement to begin leveraging this groundbreaking new tool.
Why Clinical Trial Oversight is Important
Clinical trial oversight refers to the activities and responsibilities carried out by Sponsors, CROs, and regulators to ensure that a clinical trial is conducted ethically and safely, with high-quality data, and in compliance with protocol, GCP, and regulatory requirements. It’s the ongoing supervision of every aspect of a trial to protect patient safety, maintain scientific integrity, and ensure the trial results are trustworthy.
Effective oversight is critical because the failure rate of drug discovery/development is about 90%, with up to 50% of that attributed to lack of clinical efficacy.2 This is often a data problem, not just a science problem. Poor-quality data, inconsistent site practices, and protocol deviations can all mask or dilute a true efficacy signal. Tools like SPOT optimize monitoring resources, cutting costs while simultaneously protecting the integrity of efficacy data.
What Can SPOT Do?
SPOT moves beyond traditional source data review methods to enable targeted source data verification and review strategies. Put simply, SPOT can help reduce unnecessary clinical trial site monitoring work and allows for better allocation of monitoring resources. This helps study managers and their teams align data verification and review efforts and better plan monitoring visits based on each site’s unique needs and risks.
Designed to facilitate adaptive clinical trial site monitoring in real time, SPOT quickly identifies data anomalies and supports data-driven decision-making. This can lead to improved study performance evaluation, site visitation planning, and risk assessment. All with the documentation needed to satisfy regulatory requirements and aid successful workflow.
By utilizing SPOT, teams will be able to more accurately assess risk and consider their resource workload to adjust site visit plans and avoid unnecessary delays.
The Benefits of SPOT
- Quickly evaluate and assess site performance
- Implement targeted SDV and SDR
- Simplify the planning of study monitoring visits
- Optimize the site recruitment process
- Evaluate CRA effectiveness across studies
- Mitigate inherent risks
What Are SPOT’s Top Features?
SPOT has several core features that eliminate labor-intensive manual assessments for study leadership and support teams, enabling a fit-for-purpose approach to clinical trial site monitoring.
- Seamless data integration and visualization centralize info for fast decision-making
- Configurable data-driven site scoring creates a clearer picture of clinical site statuses
- Automated and user-triggered actions set the stage for swift, proactive site management
- Role-based security measures and accountability add visibility for managers and CRA activity
- Study-level configurations let users tailor right-size strategies to mitigate clinical trial risks
Dive Deeper into SPOT
Efficient site selection, recruitment, management, and ongoing optimization are pivotal to the success of clinical trials. SPOT gives teams long-term consistency and control in clinical trial site monitoring across resourcing models and therapeutic areas. While it can be daunting to adopt a new technology, CluePoints supports every step of the implementation process with expert training and validation, as well as custom dashboards, templates, and data transformation capabilities. This helps users make the most of their investment in adaptive site monitoring and clinical research.
What Does the Clinical Trial Monitoring Process Look Like with SPOT?
CluePoints’ SPOT modernizes and automates many manual, time-consuming tasks in traditional clinical trial site monitoring by shifting from fixed, calendar-based visits to a data-driven, adaptive model. Here’s how SPOT streamlines each step of the monitoring process:
- Site Initiation Visit (SIV): SPOT supports risk-based site selection by analyzing data trends and providing centralized visibility into site readiness before activation.
- Regular On-Site Monitoring Visits: SPOT enables dynamic scheduling based on real-time risk and workload, automates visit decisions (e.g., schedule, cancel, or switch to remote), and centralizes site risk insights in one dashboard.
- Query Resolution: SPOT integrates with CTMS, EDC, and monitoring systems to flag real-time issues and streamline query resolution through centralized data access.
- Monitoring Reports: SPOT automatically tracks actions and decisions with full audit trails and offers customizable reports and real-time visualizations to support oversight.
- Close-Out Visit: SPOT highlights unresolved issues and provides visibility into protocol deviations, streamlining site close-out.
See More Success with SPOT
Whether used alongside RBQM or as a standalone resource, SPOT provides a pathway to streamlined, efficient, and effective clinical trial management. It’s not just a tool. It’s a transformational solution that flexes to meet the ever-evolving needs of clinical trial teams and the important work they do every day.
Pairing SPOT with our Risk-Based Quality Management solution maximizes its potential to ensure proactive, data-driven monitoring and oversight. Together, SPOT and CluePoints RBQM build a holistic risk-based strategy to support central and on-site monitoring, medical review, and quality risk management in all trials. As a pioneer in the RBQM space, CluePoints can help you join other leading sponsors and CROs in adopting the right technology and skills to navigate the industry paradigm shift to RBQM.
Learn more about SPOT, and schedule a demo with CluePoints to see why SPOT is redefining the standards of site monitoring in clinical research.
References:
- Branch, E. Ways to Lower Costs of Clinical Trials and How CROs Help. American Pharmaceutical Review. 2016. https://www.americanpharmaceuticalreview.com/Featured-Articles/185929-Ways-to-Lower-Costs-of-Clinical-Trials-and-How-CROs-Help/
- Sun D, Gao W, Hu H, Zhou S. Why 90% of clinical drug development fails and how to improve it? Acta Pharm Sin B. 2022. https://pmc.ncbi.nlm.nih.gov/articles/PMC9293739/
