Dedicated early phase clinical units

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Purpose-built to accelerate your path to early phase milestones

Parexel's early phase network comprises four wholly owned clinical units strategically located across Los Angeles, Baltimore, London, and Berlin, complemented by an ever-expanding network of partner sites globally. Our purpose-built, hospital-based facilities combine decades of clinical pharmacology expertise with modern technology to deliver efficient enrollment, comprehensive clinical support, and 24/7 participant oversight. Whether advancing first-in-human studies or complex pharmacology designs, we provide the integrated guidance and agile solutions that accelerate your path to market—all while maintaining the highest standards of safety and quality.

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Parexel-owned early phase clinical unit trials, past 5 years

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healthy volunteers and patients enrolled
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studies
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first-in-human (FiH) studies

Global early phase network

OTHER LOCATIONS

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Study designs

  • First-in-human
  • Dose escalation
  • Food-effect
  • Drug-drug interaction
  • Ethnobridging
  • Thorough QT
  • Bioavailability
  • Bioequivalence
  • Proof-of-concept
  • Hepatic impairment
  • Renal impairment
  • Biomarker/biobanking
  • Method development
  • Hybrid studies (healthy participants and patients)

Therapeutic area expertise

  • Allergy & immunology
  • Cardiovascular
  • Dermatology
  • Endocrine & metabolism
  • Gastroenterology & hepatology
  • Genitourinary & nephrology
  • Hematology
  • Infectious diseases & vaccines
  • Neurology & psychiatry
  • Oncology
  • Ophthalmology
  • Orthopedics
  • Respiratory
  • Rheumatology
  • Women’s health

Global site partner network

  • Best-in-class, global, integrated ‘full circle’, early phase solution in the market
  • Parexel-owned EPCUs as integral part of a flexible early phase global site network
  • One team and a seamless conduct from first-in-human to proof-of-concept
  • Strategic feasibility team to manage healthy participant and patient feasibility
  • New pricing model – new algorithms tailored to early phase studies
  • 50+ sites and growing

Right-fit, agile solutions

Parexel early phase clinical units
Network of hospital-based clinical pharmacology units with vast participant databases and qualified clinical research staff. Focuses on studies in healthy participants and small patient groups with full-service capabilities for early clinical development. Close collaboration among EPCUs enables rapid recruitment and enrollment with niche specialized capabilities.

Metasite "hybrid" concept
Combines EPCUs with a global network of alliance sites featuring clinical pharmacology or hospital infrastructure. Designed for complex, adaptive, and integrated protocol studies with programmatic oversight to accelerate drug development. Enables seamless transition from first-in-human to Phase IIa studies, with Parexel project management ensuring on-time delivery and quality standards.

External sites & partnerships
Operates APAC partner sites with Parexel local oversight for regulatory, quality, and data services. Provides solutions for niche clinical pharmacology studies including renal/hepatic impairment assessments and first-in-patient early phase studies. Established partnerships with professional centers offering specialized methods such as imaging capabilities.

First-in-Human (FiH) studies

  • Hospital-based clinical units
  • Implementation of the EMA FiH Early Phase guideline (EMEA/CHMP/SWP/28367/07 Rev. 1) and other applicable guidelines for Phase I studies
  • Three step risk assessment by translational scientist along with principal investigator
  • Adding value to protocols through adaptive trial design
  • ALS/ILS/BLS training for all physicians and nurses
  • 24/7 safety coverage, 24-hour on-site physician (as needed)

Proven China expertise

  • Expert team dedicated to early phase studies
    • Early phase project management team with 10+ years industry experience
    • Global clinical pharmacology SME based in China supporting early development strategy, regulatory engagement, study design and conduction
    • Leverage Parexel’s extensive early phase experiences from global EPCUs in the US/EU/UK
  • Local services:
    • Data management
    • Biostats/programming
    • Site monitors
    • PK scientists
    • Medical writing
  • Strategic partner sites overseen by Parexel China EP team
    • West China Hospital (100 beds), Chengdu, Sichuan
    • Shanghai Xuhui Central Hospital (141 beds), Shanghai
    • PKUCare Luzhong Hospital (100 beds), Zibo, Shangdong

HIGHLIGHTS

High performance begins with efficient enrollment. Our facilities are streamlined for high-volume screening, admissions and follow-up visits, reducing time to enrollment without compromising quality. Extensive participant databases and strategically located facilities provide access and agility in the recruitment of diverse and special populations.

Participant safety is paramount to everything we do. Our hospital-based units provide the highest level of oversight with 24/7 participant coverage, consultation support, emergency training, and immediate hospital resuscitation teams. Thoughtfully designed with participant comfort in mind, spaces are intuitive and welcoming, establishing an environment that enhances well-being and supports participant retention.

Our clinical units are equipped to deliver at scale. Purpose-built, each unit features flexible ward configurations, tailored to meet the needs of the most complex clinical pharmacology studies. Dedicated, in-unit pharmacies and laboratories support complex compounding and high-volume sampling requirements.