Phase I oncology and cardiometabolic protocols are asking participants to do more: body composition scans, retinal imaging, echocardiograms, timed against dosing windows that leave little room for travel delays. That friction has a direct cost. When a participant misses or defers an assessment because it requires a separate facility visit, the data gap often cannot be recovered.
Medpace’s Phase I Unit in Cincinnati has expanded to absorb several of those assessments on site. Licensed optometrists now perform ophthalmic evaluations inside the unit, covering visual acuity, slit-lamp and posterior segment exams, OCT and OCTA, fundus photography, and microperimetry. Echocardiography and ultrasound are also available through qualified partners who bring personnel and equipment directly into the unit rather than routing participants elsewhere. For modalities that genuinely require dedicated facilities, such as MRI or DXA, the unit coordinates through external imaging partners while routing reads through Medpace Core Labs, which uses Medidata Rave Imaging to consolidate site data entry and image uploads into a single platform.
The operational logic is straightforward. Early-phase trials already impose a significant schedule on participants: repeat dosing visits, PK blood draws, safety monitoring. Each additional off-site assessment adds a logistical dependency that can shorten the recruitment window or inflate dropout risk. Pulling those assessments inside an 85-bed, 60,000-square-foot facility established in 2008 compresses the coordination problem and keeps imaging endpoints on the same visit schedule as everything else. The FDA has long recognized that imaging technologies provide critical biomarkers in early development, and sponsors are increasingly encoding those endpoints in Phase I protocols rather than deferring them to later stages.
The practical test for this model will be protocol complexity: whether the on-site and coordinated modalities together cover what a sponsor writing a novel biologics or metabolic disease FIH trial actually needs, without forcing workarounds that reintroduce the vendor management burden the integrated model is designed to eliminate.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
