Clinical Pharmacology Services
The experience you need to make rapid “go/no-go” decisions
We inform decision-making and accelerate development by navigating the complexities of early phase studies, anticipating risks and opportunities and applying data-driven insights.
Built for success
Fortrea has more than 250 team members fully dedicated to early phase studies.
Deep experience
Our clinical pharmacology team brings over 30 years of direct drug development experience.
A vast site network
Optimize your early phase studies with 300+ investigator sites across the globe.
Phase I Site Partnerships, Selection and Feasibility
As well as the 4 dedicated Fortrea CRU’s in the USA and UK, Fortrea has developed an extensive phase 1 site partnership network of over 290 phase 1 clinical sites.
Our partnerships extend globally, with successful collaborations in regions such as Asia, Europe, and North America, and are supported by dedicated resources such as project management, medical and scientific operations, pharmacy, clinical monitoring, and biometrics.
Healthy subject recruitment is a cornerstone of successful Phase I clinical trials. Our extensive database of almost 155,000 volunteers ensure efficient and high-quality recruitment for phase 1 studies.
Our dedicated recruitment teams, recruitment website and outreach activities streamline the recruitment process. Our clinical pharmacology units are strategically placed in Dallas, Madison, Leeds, and Daytona Beach to access large potential populations, providing a robust infrastructure for Phase I trials.
Dallas: Our Dallas unit boasts a database of over 69,900 healthy participants, ensuring a diverse pool of volunteers for various studies.
Madison: The Madison CRU has a database of 43,700 healthy participants, providing a substantial resource for rapid and efficient recruitment.
Leeds: In Leeds, we have successfully nurtured the details of 13,850 healthy participants, demonstrating our capability to engage volunteers in the UK.
Daytona Beach: Our Daytona Beach clinical research unit has a database of 27,200 healthy participants, ensuring a steady flow of volunteers for clinical trials.
Fortrea’s ability to recruit for small and large cohort studies depends upon our ability to reach out to these individuals quickly and efficiently, and to recruit new potential participants via a dedicated recruitment website, www.fortreaclinicaltrials.com
Fortrea ensures high-quality clinical research through expert medical and clinical monitoring. Our specialists oversee trial progress, protect participant safety, and ensure data accuracy and regulatory compliance. With over 16 years of average industry experience, our physicians and scientists have supported 400+ studies in the last 5 years [2019-2024]. They collaborate closely with clinical teams to provide real-time insights and address medical issues promptly. This integrated approach upholds the highest standards of patient care and data integrity throughout the trial.
- Experienced, in-house team
- On-site medics to support studies
- Experience spanning 400+ successful studies
PK/PD monitoring is vital to understanding a drug’s behavior and effects. Fortrea’s clinical pharmacology team is familiar with the use of advanced tools like liquid chromatography, mass spectrometry, and immunoassays to precisely measure drug levels in small molecules and biologics. We assess drug efficacy and toxicity through PD monitoring, evaluating biomarkers and clinical endpoints to define optimal dosing. Our approach includes non-compartmental and compartmental analyses using data from plasma, blood, urine, and more. We also apply H2 simulation techniques to predict drug behavior and optimize study design, supporting informed decisions throughout the clinical trial process.
Fortrea’s integrated services gives us the ability to deliver Rapid topline PK data, providing sponsors with valuable insights into the pharmacokinetic (PK) properties of an asset, and helping steer decision making about follow-on pharmacology studies and clinical development. By delivering topline PK insights as quickly as 5 days from database lock, we enable sponsors to make timely go/no-go decisions, refine study protocols, and expedite regulatory interactions.
Find out more.
Link to document AR_0007_Rapid PK Data_0424_HiRes (1).pdf
With over 140 impairment studies completed, Fortrea’s renal studies are supported by a dedicated impairment team and a global network of over 25 Phase I-qualified renal sites, ensuring access to both dialysis-dependent and non-dialysis-dependent populations.
These studies are executed with intense medical oversight, centralized IRBs, and a two-step eligibility process, ensuring faster enrollment, increased safety, and high data reliability.
Fortrea’s CRUs in Dallas, Daytona Beach, Madison, and Leeds are equipped for complex procedures like CSF collection, FibroScan®, and cognitive testing, and are supported by cGMP pharmacies and on-site bioanalytical labs.
[Hyperlink to this document – SS_0006_CPS_Impairment Study_0524_HiRes.pdf
…and this article - AR_0009_Renal Impairment_0924_HiRes.pdf ]
Drug-drug interaction studies involve assessing the pharmacokinetic (PK) and pharmacodynamic (PD) interactions between investigational drugs and other medications. This is essential for identifying potential adverse effects and optimizing dosing regimens.
Our dedicated team of medical and scientific experts employs rigorous methodologies to conduct DDI studies, including noncompartmental and compartmental analyses, physiological-based pharmacokinetic (PBPK) modeling, and population PK analysis. These techniques enable us to provide comprehensive insights into drug interactions, supporting informed decision-making throughout the drug development process.
Fortrea has successfully conducted over 90 drug-drug interaction (DDI) studies in the past five years, demonstrating deep expertise in this critical area of early clinical development. These studies span a wide range of therapeutic areas and include both healthy volunteer and patient populations.
Fortrea has conducted over 170 Phase I studies in the past five years, many of which involved large cohorts and complex, combined protocols. These include hybrid SAD/MAD, food effect, and patient-access designs. Fortrea’s CRUs—Dallas, Daytona Beach, Madison, and Leeds—are purpose-built to accommodate high-volume dosing, with 72–100 beds per site and 24/7 operations. Our integrated delivery model, featuring in-house cGMP pharmacies, centralized recruitment, and real-time data capture, enables rapid enrollment and high retention. Over 70% of FIH studies are adaptive, allowing seamless transitions across cohorts and study phases, reducing timelines and maximizing data yield.
Fortrea has conducted 50+ studies involving QT assessments, including Thorough QT (TQT) studies, over the past five years. These studies are supported by intensive cardiac monitoring infrastructure across all Fortrea Clinical Research Units (CRUs), including continuous 12-lead ECG, telemetry, Holter monitoring, and Mortara Surveyor systems.
Importantly, many of these TQT studies are embedded within complex, combined protocols. For example, Fortrea has executed TQT studies that include a SAD (Single Ascending Dose) component within the same protocol, enabling dose selection based on interim safety and PK data. This integrated approach allows for single protocol and regulatory submissions, reducing both time and cost while generating additional exposure data that can support other studies such as renal or hepatic impairment assessments.
Fortrea brings deep expertise in recruiting and conducting Phase 1 studies involving special populations, including elderly, obese, post-menopausal women, and patients with renal or hepatic impairment.
Recruiting special populations is supported by a dedicated impairment team and a network of over 65 experienced sites. These sites are pre-qualified for specific population access and are often located near Fortrea’s CRUs in Dallas, Daytona Beach, Madison, and Leeds. Recruitment is accelerated through:
- Centralized IRBs and streamlined eligibility processes.
- Pre-screened patient databases and partnerships with community clinics.
- Digital outreach and AI-driven feasibility tools to match patients to protocols.
- Multilingual staff and culturally sensitive materials to support diverse populations.
In key therapeutic areas, particularly in oncology, hepatology, and immunology indications, demand for Phase 1b studies with patients is increasing. Fortrea CPS excels in delivering Phase 1b and hybrid studies through a nimble, patient-centric model that integrates therapeutic area expertise with clinical pharmacology precision.
These studies often involve complex designs—such as adaptive protocols and hybrid SAD/MAD/FE/DDI cohorts—executed across Fortrea’s global network of MHRA-accredited clinics and specialized partner sites.
Fortrea has conducted over 100 ethnobridging studies, with more than 3,000 Asian subjects randomized and completed across the US, UK, and Europe. These include SAD, MAD, FE, DDI, AME, and biosimilar studies, often embedded in complex, adaptive protocols. Our long-standing work with UK Chiken Services Ltd (CHIKENGLOBAL) ensures culturally tailored recruitment, translation, and in-clinic support. With a 100% retention rate at our Leeds CRU successful studies in our Dallas clinical research unit in the USA, Fortrea’s integrated model delivers high-quality data and seamless execution for Asian bridging programs—making us a trusted partner for global development.
Food effect studies are essential for understanding how food impacts the absorption, distribution, metabolism, and excretion of drugs, ensuring optimal dosing and efficacy.
Food effect studies involve assessing the drug absorption and pharmacokinetic properties of a drug when administered with food versus a fasted state. This is crucial for determining the best administration guidelines for new medications.
Fortrea Clinical Pharmacology Services (CPS) has conducted at least 60 food effect studies over the past five years, including:
- 21 food effect studies between 2017 and 2021 at the Leeds CRU .
- The Dallas CRU contributed 25 food effect studies in the same period.
- The Daytona Beach CRU added 17 food effect studies.
Fortrea’s Clinical Pharmacology Services (CPS) has conducted over 130 SAD/MAD studies in the past five years across its global Clinical Research Units (CRUs). These studies are foundational to early-phase development, enabling safe dose escalation and pharmacokinetic profiling in healthy volunteers and special populations.
A significant proportion—over 70%—of First-in-Human (FIH) studies at Fortrea are adaptive SAD/MAD designs, often embedded within complex, combined study programs that integrate food effect, DDI, or patient cohorts. These hybrid protocols allow seamless transitions from SAD to MAD phases, and even into proof-of-concept in patients, accelerating timelines and optimizing data collection.
Informed decisions for asset development
Fortrea provides the link between preclinical data and new treatments for patients. Our dedicated scientists and clinicians deliver comprehensive drug safety, tolerability, pharmacokinetic and pharmacodynamic data—and a complete in-house team to enable you to scrutinize development progress and deliver unique insights that inform critical decisions. As one of the largest early stage clinical research organizations in the world, we offer a comprehensive suite of pharmacology services to manage every step of your early clinical development.
The expertise to manage complexities
As we manage the conduct of your complex study, we never take our eyes off the two critical focal points—scientific integrity and human subject safety. Fortrea is built to manage the ever-growing complexity of product development with end-to-end patient safety solutions. Our integrated clinical study platform handles multisite hybrid study designs, rapid-sequence dose escalations, sophisticated biomarker or imaging exploratory endpoints, extemporaneous investigational product preparation and more.
Early phase experience that matters
In the past five years we have:
A flexible model delivers the right support
You only need access to the resources that matter most to your study, and you shouldn’t have to deal with a bigger footprint than you need. We understand. That’s why we deliver the right combination of strategy and execution, resources and tools that help you meet your end goals.
We offer you a deep, experienced team focused on this crucial phase of molecule development and deliver results as you introduce your compound in humans and move to proof-of-concept. Let us partner with you as you transition into the clinic with an eye toward future phases.
