Accelerate Phase I Clinical Trial Success with Medpace CRO
Pressure to contain the rising costs of drug development continues to force biopharmaceutical Sponsors to find ways to inject efficiencies into the research process. As a result, early-phase study design and its effect on predicting late-phase research outcomes are critical.
Ensure efficiencies with your early-phase clinical pharmacology trial by partnering with the fully-integrated Medpace Phase I Unit. From consultation on protocol designs to our innovations in translational medicine, our therapeutically aligned team work as dedicated partners to deliver projects according to each Sponsor’s specifications.
Embedded Physician Leadership
The therapeutically aligned teams work as innovative partners with the Phase I Unit to deliver projects according to each Sponsor’s specifications.
Leverage Full-Service Solutions for
The Phase I Unit draws on the extensive expertise of Medpace CRO to provide a full range of early-phase clinical research services, including regulatory consulting for early-phase development protocol design and writing, development of innovative processes for complex studies, pharmacokinetic and translational medicine consulting, project management, data management, and biostatistics.
Early-Phase Services & Study Designs
- First-in-human (FIH)
- SAD / MAD
- Dose escalation
- Single or multiple dose studies
- Bioavailability / bioequivalence
- Drug-drug interaction
- Food effect
- Phase IIa, Proof of concept
- Thorough QR / QTc
- Device and diagnostics
- Adaptive design
The Medpace Phase I Unit Facility
The Medpace Phase I Unit facility offers excellence in research capabilities and provides high-end amenities to volunteers. With the ability to conduct clinical pharmacology studies in three independent patient units, the state-of-the-art facility was built to accommodate small and large-scale studies. Its features include a 60,000 square-foot in-patient and out-patient facility, 60 beds (semiprivate and dormitory-style modules), centralized laboratory processing, licensed Investigational Drug Services/Pharmacy, centralized food service, 24/7 security, and certified advanced cardiac life support (ACLS) personnel on staff.
State of the Art Equipment
- Mortara Surveyor Telemetry Central System with 32 telemetry channels
- Mortara 12-lead ECG machines
- Welch Allyn Spot Vital Sign machines
- Fully stocked emergency crash carts with Zoll M Series defibrillator and external pacing device
- Master clocks with synchronized time
- Generator back-up for continual power supply
- Laboratory processing and storage area with refrigerated centrifuges and –20*C/-70*C freezers
- Continous temperature and humidity monitoring of lab and pharmacy areas by REES environmental monitoring system
shared campus = efficient, integrated research
Effective recruitment and retention of normal, healthy and specialty patient populations
The Phase I Unit has a dedicated staff for the recruitment and screening of study subjects. We continuously develop and nurture our volunteer database of active potential study subjects for multiple types of clinical trials, helping enroll trials quickly and efficiently.