Early Phase I Clinical Development
With the ever-increasing complexity of Phase I trials, we have you covered.
Discover the Fortrea Difference
We specialize in designing and executing customized studies that drive your drug development forward. Our Phase I and clinical pharmacology services are tailored to meet the specific needs of your program, whether it’s a challenging study design or a unique objective.
Our commitment starts with our first conversation and lasts throughout our entire working relationship. You’ll see it in the dedication of our staff, the flexibility and availability of our leadership team, and the services you receive.
It is our mission to deliver quality data faster, allowing your asset to accelerate to the next step.
Comprehensive Support for Every Step of Your Clinical Journey
No two studies are the same, and neither are their paths to success. We’re committed to offering bespoke support at every stage of your clinical development journey.
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Medical / Scientific Consultation
- Concept and Regulatory Approach
- Protocol Design
- Program Development
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Phase I Clinical Conduct
- Fortrea CRU Site
- QA Approved Phase I Global Site Network
- Recruitment of Healthy Patient Populations
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Bioanalytical Sample Collection Services
- Customizable PK and PD collection kits and bulk supplies
- Kits supplied with labeled tubes on a per-visit basis
- Training materials included as part of kits
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Full Suite of Clinical Pharmacology Studies
- First-in-Human
- Integrated SAD and MAD (includes FE/DDI/BA/EPQT)
- Drug-Drug Interaction
- BE/BA
- Food and Meal Timing Effect
- PK/PD
- AME/Mass Balance/Metabolite Profiling
- Renal Impairment
- Hepatic Impairment
- Expert Precision QT and Thorough QT Evaluations Impairment
- POC Studies in Patients
- CSF Collection and Analysis
- Specialty Procedures (Biopsies, NG tube, and unique routes of administration)
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Bioanalytical Lab in Austin, Texas
- GLP and Part 11 Compliant; Support Regulated Bioanalysis (Clinical Studies, GCP)
- Small and Large Molecule Bioanalysis, Pharmacokinetic Analysis and Reports
- DEA and RAD-licensed
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Pharmacokinetics / Pharmacodynamics
- PK/PD/Tox Analysis and Reports
- Consultation Services
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Data Management / Biostatistics
- Phase I Focus and Expertise
- Dedicated Phase I Teams
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Scientific and Medical Report Writing
- Protocols and Synopsis
- Informed Consent Document
- Clinical Study Reports
The Fortrea Edge
We know our people, processes, and technologies can play a key role in your asset’s success. This understanding is at the heart of our continuous innovation initiative—The Fortrea Edge.
Award-Winning Phase I Services
Clinical Leader announced the 2024 Leadership Awards, supported by data from ISR Reports, naming Fortrea Clinical Trials the highest-rated Phase I Service Provider for Overall User Preference and the highest-rated Phase I Service Provider for Data Management.
A Tailored Program, Every Time
We understand that no two Phase I trials are the same. That’s why we offer flexible, customized solutions through our state-of-the-art bioanalytical laboratory, full-service, fit-for-purpose clinical pharmacology unit, and specialized pharmacy services. With an unwavering commitment to excellence, we deliver high-quality data faster, ensuring your asset progresses seamlessly to the next phase without compromise.