With the launch of a newly built, state-of-the-art clinical pharmacology unit, Medpace strengthens its position as a strategic early phase partner, delivering integration, scientific precision, and operational control that translates early insight into downstream success. Featuring Shabaz Khan, MD, Senior Director, Medpace Clinical Pharmacology Unit.
Early-Phase is the Strategic Inflection Point of Clinical Development
The early stages of clinical development represent a critical juncture—where Sponsors not only collect foundational data but establish the trajectory of their clinical program. Decisions made during this stage—in protocol design, operational execution, and data collection—profoundly influence future milestones, from dose selection and patient safety to regulatory alignment and commercial steadiness.
Yet in an environment of increasing complexity and compressed timelines, biopharmaceutical Sponsors need more than a capable site; they need a partner with the foresight and infrastructure to optimize for the long term. Even minor missteps at this stage can compound into costly delays later in development.
At Medpace, we recognize that early phase trials are not isolated exercises in feasibility. They are the foundation for what comes next. That’s why Medpace has made a strategic investment in our early phase capabilities, designed to accelerate today’s complex early phase development programs with confidence and control.
Introducing Our Newly Constructed, State-Of-The-Art
Phase I Unit
Located on our dedicated research campus in Cincinnati, Ohio—and fully embedded within Medpace’s global, full-service CRO model—the Medpace Phase I Unit is purpose-built to support today’s most demanding early phase studies.
An Environment Engineered for Complex Early Phase Trials
This expansion is more than added capacity—it’s an operational advancement. Our new unit was designed to meet the evolving demands of early phase clinical research: more intensive protocols, more nuanced endpoints, and more integrated data needs.
Facility highlights include:
- Four independent inpatient units, designed to accommodate a broad range of clinical pharmacology studies.
- 85-bed capacity, including semi-private suites and patient-centric design to enhance retention and protocol continuity.
- A dedicated, licensed Investigational Drug Services Pharmacy, equipped for radiolabeled and complex investigational products.
- On-campus access to central labs, imaging, biostatistics, and medical writing.
- 24/7 physician oversight with ACLS-certified staff and embedded early-phase specialists.
“We designed this facility to eliminate friction between data generation and decision-making,” shares Dr. Shabaz Khan, Senior Director of the Phase I Unit at Medpace. “Everything from the medical to biometrics team is integrated in real time, enabling Sponsors to evaluate signals quickly and confidently, without sacrificing scientific depth or quality.”
Translating Early-Phase Insight to Late Phase Success
In today’s environment, Sponsors must treat early phase not just as a point-in-time trial, but as a strategic platform for accelerating development. Medpace’s integrated model and therapeutic alignment enable our teams to design and execute studies that deliver more than baseline data—they deliver clarity on what comes next.
Our early-phase expertise spans the full range of clinical pharmacology studies. We routinely support:
- First-In-Human (FIH)
- Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)
- Drug-Drug Interaction
- Food Effect
- Bio-availability
- Bio-equivalence or Biosimilar
- Thorough QR/QTc
- Crossover
- PK/PD
- Dose Escalation
- Phase IIa or Proof of Concept
- Device and Diagnostics
- Adaptive Design
“Early decisions drive late-phase outcomes,” Dr. Khan adds. “We bring together therapeutic insight, operational rigor, and an integrated campus to help Sponsors make those decisions with confidence.”
Advancing the Standard for Early Phase Research
From First-In-Human to First-In-Market, Medpace is Your Partner in Early Phase Success
Unlike siloed CRO partnerships, Medpace’s newly built Phase I Unit operates within a fully integrated global CRO model, bringing early phase execution, scientific insights, and downstream planning under one roof. This vertical integration gives Sponsors real-time visibility, control, and continuity, eliminating the typical handoffs that delay progress or introduce variability between early and late phase teams.
“We’ve designed an environment where early-phase data generation aligns seamlessly with strategic decision making,” says Dr. Khan. “For Sponsors, that means faster timelines, higher-quality data, and a smoother transition into later phases of development.”
Whether you’re initiating a first-in-human trial, planning an adaptive escalation strategy, or navigating the complexities of novel modalities, Medpace offers the infrastructure, expertise, and integration to help you move your program forward—confidently and efficiently.