Site monitoring is one of the most expensive components of clinical trials; on-site 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 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.
Learn more about SPOT from CluePoints, the site profile and oversight tool.
What Is SPOT?
The Site Profile & Oversight Tool from CluePoints is a cutting-edge technology for adaptive 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.
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 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 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 site monitoring.
- Seamless data integration and visualization centralizes 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 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.
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.
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/
