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Isabel Dorion, Senior Director of Clinical Operations at Indero, joins as today’s guest. With over 25 years of experience in clinical research, she has made significant contributions across phase I to IV trials, bringing deep expertise in both site-level operations and the complexities of the CRO environment. In her current role, she leads the North American clinical monitoring team, ensuring operational excellence and upholding the highest standards in Clinical Research Associate (CRA) performance. This episode explores the importance of CRA oversight, the strategies used to maintain quality, and the added value of hands-on support in the field.
The Critical Role of Oversight in Clinical Trials
Oversight of clinical trials is both a regulatory and contractual obligation to sponsors. At the core, this involves safeguarding patient safety, protecting patient rights, and ensuring the integrity of the data collected—so that any approved drug is backed by reliable, high-quality evidence. To achieve this, a robust monitoring plan is implemented, incorporating CRA on-site and remote visits. These efforts ensure that sites adhere to the protocol, remain in compliance with study expectations and regulatory requirements, and follow International Council for Harmonisation (ICH) – Good Clinical Practice (GCP) principles. Monitoring visits are further supported by cross-functional data reviews conducted by central monitors, medical monitors, and data management teams. These reviews help identify trends or safety concerns that require CRA follow-up.
The Broad Impact of CRAs on Study Success
CRAs serve as the boots on the ground, acting as the primary point of contact for clinical sites and serving as the eyes and ears for sponsors, project managers, and clinical trial managers (CTM). From study start-up, CRAs lead site initiation visits, training site personnel on the protocol, study procedures, recruitment expectations, and timelines. This early engagement lays the foundation for site success, promoting high-quality data collection and the protection of patient rights and safety.
During the conduct phase, CRAs carry out routine monitoring visits. These visits involve reviewing participant medical records to confirm proper informed consent, verifying inclusion and exclusion criteria, and assessing site processes. Source data review and source data verification are performed to ensure compliance with the protocol, regulatory requirements, and GCP. CRAs also verify that data is accurately captured and that good documentation practices are met, while confirming that the principal investigator (PI) maintains adequate oversight of the site team.
In addition to monitoring responsibilities, CRAs provide ongoing support to sites, assisting with recruitment challenges and addressing operational issues. The CRA role is central to ensuring protocol adherence, site compliance, and, ultimately, patient safety.
Oversight Practical Strategies
At Indero, a dual reporting structure is in place for CRAs. Each CRA reports to both a CTM for study-specific oversight and a Clinical Operations Manager (COM) for broader operational alignment. Both the CTM and COM are jointly responsible for monitoring quality, with key performance indicators (KPIs) serving as primary tools for oversight.
KPIs include completion of thorough trip reports following each site visit—essential deliverables that must accurately reflect monitoring activities, site compliance, safety observations, protocol deviations, and any required follow-up actions. Timely submission of follow-up letters to sites is also a critical metric. These letters ensure that PIs are clearly informed of observations and expectations so that appropriate corrective actions can be taken.
Oversight teams not only verify that these deliverables are completed but also assess their timeliness to ensure contemporaneous documentation—enabling swift resolution of site-level issues. Adherence to monitoring visit schedules as outlined in the monitoring plan is another KPI closely tracked. Indero applies an adaptive, risk-based monitoring approach; therefore, visit frequency may be adjusted based on signals identified through central monitoring, data management, or medical monitoring. Flexibility and responsiveness from CRAs are essential when visit schedules shift based on emerging site needs.
To support quality, a dedicated team of trip report reviewers examines the content for completeness and accuracy. CTMs also conduct quality control checks of both trip reports and follow-up letters to confirm that issues are addressed properly and that corrective and preventive action plans are implemented when necessary.
Periodic quality compliance reviews of the trial master file (TMF) are conducted to ensure constant inspection readiness. CRA training—both project-specific and administrative—is also monitored to ensure it is completed promptly, enabling CRAs to fully support their assigned sites.
Additional quality assurance measures include quality assessment visits and accompanied oversight visits with CRAs. COMs also gather feedback regularly through quarterly performance evaluations. These evaluations assess not only the CRA’s adherence to KPIs but also soft skills such as communication, responsiveness, innovation, and site support. Feedback is gathered from both internal team members and sites. These qualitative insights help distinguish high-performing CRAs from average performers, reinforcing a culture of excellence in monitoring.
Key Elements in Quality Reviews
Emphasis is placed on proper and thorough documentation. Trip reports and follow-up letters must accurately and comprehensively summarize on-site activities, including any non-conformances or issues observed. Documentation should clearly outline corrective actions and track the resolution of action items within appropriate timelines.
Timeliness is a critical focus—whether related to the submission of deliverables such as trip reports, visit reports, and follow-up letters; the scheduling and completion of monitoring visits; or the collection and filing of essential documents. Maintaining an up-to-date and inspection-ready TMF is essential to ensuring regulatory compliance and overall study quality.
Quality Reviews: Metrics That Matter
Quality oversight visits are considered instrumental to effective monitoring. These visits may be conducted by either the CTM or the COM and serve three primary purposes.
First, they offer a valuable opportunity to assess CRA competencies through direct observation, allowing for real-time coaching, mentoring, and professional development. This in-person interaction helps strengthen engagement and fosters stronger working relationships with CRAs.
Second, oversight visits provide an additional layer of site evaluation. A second set of eyes can assess site processes, review documentation practices, and verify that the PI is maintaining appropriate oversight.
Third, these visits allow for meaningful, face-to-face interaction with site staff, creating space for open dialogue and feedback. Site teams are encouraged to share input on CRA performance—focusing on responsiveness, professionalism, punctuality, and the level of support provided. Feedback is also gathered on cross-functional support, including experiences with contract and budget negotiations, data management queries, patient recruitment efforts, medical monitor availability, and the clarity and timeliness of site payments.
This comprehensive, in-person approach strengthens the site-CRO relationship, ensures that concerns are acknowledged, and reinforces a culture of responsiveness. As a result, increased engagement and communication are expected to lead to stronger site performance and improved study quality.
The Impact of Strong CRA Oversight
Ultimately, quality oversight contributes to higher standards in monitoring and documentation. It reinforces patient safety, protects patient rights, and ensures data integrity. Over time, these efforts foster more engaged and motivated sites, while also strengthening internal collaboration and team morale.
The result is increased client satisfaction and a stronger overall reputation for Indero. This approach aligns directly with the company’s core value of being frontline-focused—placing priority on customer needs. Enhancing service quality benefits all stakeholders, including patients, sites, sponsors, and internal teams, and supports the successful outcome of clinical studies. In every sense, it represents a win-win for both internal and external partners.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
