Clinical Monitoring - Dr. Vince Clinical Research

What we deliver

Monitoring plays a critical role in protecting data quality, which is why the team behind it matters as much as the process. We keep a separation between our study teams and our Clinical Research Associates (CRAs), which keeps their oversight of your data objective. Before any CRA is assigned, we present only those qualified by training and experience to you for consideration and approval, so the monitoring of your study reflects your standards from the start. On every engagement, sponsors receive:

Blinded and/or unblinded monitoring, performed in accordance with our Clinical Monitoring SOPs
CRAs with direct experience of our clinic processes, technology, equipment and investigators
Monitoring expertise across a wide range of study designs and therapeutic areas
Clear, consistent communication that gives sponsors actionable insight throughout the study

Experience snapshot

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Average years experience across our team

Phase I-III

Clinical trial experience

Our clinical monitoring approach

We maintain a separation between our study teams and our CRAs, so the team reviewing your data is independent of the team generating it, and their oversight stays objective. We present only CRAs qualified by training and experience for your consideration and approval, which means monitoring assignments are confirmed with you before work begins.

Extensive training

Each CRA completes extensive training on our SOPs, technology platforms and essential clinical processes. That preparation lets them navigate our systems efficiently and monitor data collection effectively throughout the study, so data issues can be identified during conduct, when they are easier to resolve.

Leverage local CRAs

Wherever a study allows, we leverage local CRAs, which reduces pass-through travel costs. Our CRAs are readily available to perform both blinded and unblinded monitoring, so coverage can flex to meet your protocol requirements.

Our clinical monitoring leadership

Clinical Monitoring is staffed by experienced CRAs who are qualified by training and experience and presented to you for approval before assignment. Because our CRAs work directly with our clinic processes, technology, equipment and investigators, they have a deep understanding of how our studies operate. The same experienced team supports your study through conduct, and low turnover preserves institutional knowledge and accountability across the program.

Chris Hardage

Vice President, Clinical Development

30 years of experience

Jennifer Greene

Associate Director, Clinical Monitoring

13 years of experience

Young businesswoman working on a laptop in an office alone

Technology, tools and systems

Our CRAs are extensively trained on our technology platforms and have direct experience with the systems and equipment used in our clinic, so they navigate our environment efficiently and monitor data collection effectively from the start of the study.

Quality, standards and compliance

All monitoring is performed in accordance with our Clinical Monitoring SOPs, which keeps oversight of your data consistent across CRAs and studies. Presenting only qualified CRAs, and keeping monitoring independent of the study team, supports objective review of the data throughout the study.

Clinical monitoring

Our team conducts clinical monitoring in accordance with ICH-GCP E6 (R3), applicable regulatory requirements, sponsor-specific requirements and internal Clinical Monitoring Standard Operating Procedures.

Monitoring processes

Our monitoring processes are designed to ensure participant safety, data integrity, protocol compliance and regulatory compliance throughout the conduct of a clinical study.

Standardized monitoring tools

To promote consistency and quality across studies, we utilize standardized monitoring tools, templates and quality review processes. CRAs are supported through onboarding, ongoing mentorship and performance oversight.

Connected across the full study lifecycle

Clinical monitoring works alongside the operations that depend on clean, well-documented data. Our CRAs monitor the data captured by data management, while medical monitoring provides medical and safety oversight of the same study. Your Project Manager coordinates these handoffs across the full study lifecycle.