Supporting Complex Phase I Studies Through Integrated Imaging and Specialized Assessments

Early-Phase clinical trials often require imaging and specialized assessments to be completed at specific timepoints relative to dosing. Coordinating these assessments across multiple locations can increase participant burden and add logistical complexity to study execution.

In response to Sponsor needs, the Medpace Phase I Unit has expanded its ability to bring select specialized assessments directly into the study environment, while coordinating additional modalities through qualified external partners when appropriate.

The Medpace Phase I Unit has expanded its specialized assessment capabilities in response to Sponsor needs, including ultrasound and echocardiography performed within the unit. Qualified external partners bring the necessary personnel and equipment onsite, allowing participants to complete these assessments as part of their study visits.

The Phase I Unit also accommodates on-site ophthalmic examinations performed by licensed optometrists using specialized ophthalmic equipment. The available capabilities can support a range of standard and study-specific assessments, including visual acuity, slit-lamp and posterior segment examinations, OCT/OCTA, fundus photography, microperimetry, and other protocol-specific evaluations. Performing these assessments within the Medpace Phase I Unit can reduce the need for participants to travel to separate facilities, helping streamline study visits and minimize disruption to their schedules.

While some specialized assessments can be performed directly within the Phase I Unit, other imaging modalities require dedicated facilities and equipment. For early-phase studies, these assessments can provide important insights beyond traditional safety and pharmacokinetic measures, helping Sponsors characterize changes in body composition, tissue characteristics, and other endpoints relevant to the therapeutic area.

When protocols require imaging such as MRI or DXA, the Medpace Phase I Unit can coordinate assessments through qualified external imaging partners while leveraging the expertise of Medpace Core Labs (MCL) to support the broader imaging workflow.

By connecting Phase I operations with specialized imaging expertise within a full-service CRO model, Medpace can help streamline coordination, reduce the complexity of managing multiple vendors, and support more efficient execution of studies that require sophisticated imaging endpoints.

The ability to bring specialized assessments within the Medpace Phase I Unit benefits both the participant experience and overall study execution.

• Reduced need for additional travel

• Minimized disruption to participant schedules

• Reduced burden associated with coordinating additional appointments and assessment locations

• Simplified scheduling and coordination of specialized assessments

• Improved operational predictability

• Consistency across assessments

• Access to Medpace’s integrated, full-service clinical research infrastructure, connecting Phase I operations with imaging, laboratory, clinical operations, and other functional expertise as needed

As clinical research becomes increasingly data-rich and protocols require more specialized assessments, flexibility in how and where these assessments are delivered will become ever more important. Medpace continues to evolve its capabilities and partnerships to provide flexible, integrated solutions that support changing Sponsor and participant needs.

Together, these capabilities give Sponsors greater flexibility in designing and executing early-phase studies that require specialized assessments. By combining onsite capabilities within the Phase I Unit with coordinated access to external imaging and broader Medpace expertise, this integrated approach can help align assessment requirements with the needs of the protocol and the participant experience.

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