Bridging Early-Phase Insight to Late-Phase Development
Accelerating Early phase development
In an era where rising costs of drug development compel biotechs to seek efficiencies in research projects, the design of early phase studies and their impact on predicting late-phase outcomes are more critical than ever. As you navigate the intricate landscape of Phase I trials, you deserve a partner that not only appreciates the nuances, but also possesses the expertise to propel your projects forward with confidence.
Unlike traditional Phase I Units, Medpace CRO’s extensive experience in conducting Phase II-III trials equip us with a holistic understanding of clinical development. Bridging the gap between early and late phase trials, the Medpace Phase I Unit was established in 2008, an expansion that allowed us to underscore the importance of early-phase study design in shaping late phase outcomes.
An Integrated, Scientifically-Driven Approach to Early-Phase Research
Discover the Medpace Phase I Unit’s state of the art facilities and comprehensive support services for accelerating early phase clinical development. Partner with us to bridge early phase insight to late phase successes.
Leverage Full-Service Solutions for Early-Phase Studies
The Phase I Unit draws on the extensive expertise of the 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)
Single Ascending Dose (SAD)
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
The Medpace Phase I Unit Facility
Innovation Meets Patient Comfort and Research Efficiency
The Medpace Phase I Unit facility offers excellence in research capabilities and provides high-end amenities to study participants. With the ability to conduct clinical pharmacology studies in four 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
Continuous temperature and humidity monitoring of lab and pharmacy areas by REES environmental monitoring system
Dedicated Pharmacy for Early Phase Studies
Our Investigational Drug Services Pharmacy exclusively supports our Phase I Unit with full licenses from the Ohio Board of Pharmacy and DEA for controlled substances (schedule II-V). Equipped with ISO class 5-compounding septic isolator and dedicated pharmacy balances, we uphold rigorous standards of quality and safety. Our facility includes monitored refrigeration managed by REES monitoring system.
Recruitment and Retention Strategies
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 database of active potential study subjects for various types of clinical trials, helping enroll trials quickly and efficiently.
Our database isn’t static—it’s a dynamic ecosystem that is constantly evolving. With a staggering 65,000 contacts (15,000 active), we have a vast pool of potential study participants at our fingertips. This expansive reach enables us to swiftly identify and engage participants who align with your study protocol.
Within our database, we offer access to diverse patient populations, including normal, healthy individuals, specialty populations (such as those with cardiovascular disease, diabetes, and hypertension), and specific demographics like post-menopausal, obese and elderly cohorts.
Our database’s versatility extends to a wide array of study designs, from SAD/MAD trials to food effect, DDI and TQT studies. We can ensure that the study criteria are met with precision through our database.
Harnessing Technology to Streamline Study Management
Leveraging technology is essential for optimizing study management processes and driving efficiency in early phase clinical research. At the Medpace Phase I Unit, Sponsors benefit from our proprietary software, ClinTrak EDC which sets new standards for efficiency, transparency, and compliance.
Our embedded medical leadership provides Sponsors with strategic medical guidance and diverse therapeutic expertise, in addition to comprehensive support across all trial phases.
“By partnering with the Medpace Phase I Unit for early clinical development, you can benefit from our state-of-the-art facilities and our collaborative partnership grounded in scientific and operational excellence dedicated to advancing your clinical research. Our shared research campus, adjacent to the Medpace CRO and Labs, encourages a collaborative environment that facilitates seamless communication and continual training for our research teams.
We are confident that our Phase I Unit can accelerate your early-phase development initiatives. We invite you to explore how we can help you achieve your clinical research goals by partnering with us at Medpace Phase I Unit.”
Shabaz Khan, MD Senior Director, Medpace Phase I Unit
