Clinical Pharmacology Services
Fortrea: A world-leader in early phase trial execution.
We inform decision-making and accelerate development by navigating the complexities of early phase studies, anticipating risks and opportunities and applying data-driven insights.
Deep experience
Our clinical pharmacology team brings over 40 years of direct drug development experience.
Built for success
Fortrea has more than 1200 team members fully dedicated to early phase studies, with dedicated medical, scientific, project management and biometrics groups.
Dedicated clinics with a strong site network
4 dedicated Phase 1/1b Fortrea CRUs, backed up by 300+ Phase 1 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 300+ 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, TX, Madison, WI, Daytona Beach, FL and Leeds, UK and to access large potential populations, providing a robust infrastructure for Phase I trials.
Fortrea dedicated CRU capabilities
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.
Specialized clinical monitoring is offered through its dedicated Phase I Monitoring Services (PIMS) team, comprising 40+ experienced CRAs across the US and UK. These professionals support First-in-Human to Proof of Concept trials across diverse therapeutic areas. Our risk-adaptive strategy combines remote and on-site monitoring, and integrated systems for issue escalation and eTMF management. Monitoring is embedded within a collaborative framework involving CTLs, Medical Monitors, and Project Managers.
With over 16 years of average industry experience, our physicians and scientists have supported 400+ studies in the last 5 years. 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.Specialized clinical monitoring is offered through its dedicated Phase I Monitoring Services (PIMS) team, comprising 40+ experienced CRAs across the US and UK. These professionals support First-in-Human to Proof of Concept trials across diverse therapeutic areas. Our risk-adaptive strategy combines remote and on-site monitoring, and integrated systems for issue escalation and eTMF management. Monitoring is embedded within a collaborative framework involving CTLs, Medical Monitors, and Project Managers.
- 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. 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.
Online data visualization is available to sponsors, and topline PK insights can be delivered as quickly as 5 days from database lock, enabling sponsors to make timely go/no-go decisions, refine study protocols, and expedite regulatory interactions.
Find out more: The benefits of rapid topline pharmacokinetic (PK) data in clinical pharmacology studies
With over 140 impairment studies completed, Fortrea’s renal and hepatic studies are supported by a dedicated impairment team and a global network of over 45 Phase I-qualified renal sites and 40 hepatic sites, ensuring access to all population types, including severe impairment and dialysis-dependent.
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. https://www.fortrea.com/insights/get-your-study-enrolled-designing-your-impairment-protocol-prevent-challenges
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.
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 Clinical Pharmacology Services (CPS) expertly manages large cohort, multi-site studies through a purpose-built model that ensures faster enrollment, consistent data quality, and reduced dropout rates. With four global CRUs and a 65+ site network, Fortrea delivers seamless execution across geographies. Their integrated project teams and cGMP pharmacies enable on-site manufacturing of sterile and non-sterile drug-device combinations, including injectables. Extensive experience with injection device trials—over 600 subjects in five years—ensures consistent participant experience and robust data. Fortrea’s methodology ensures aligned project management, scientific oversight, and proactive risk mitigation.
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 and Holter monitoring, and utilising Mortara Surveyor systems.
Approximately 80% of the FIH SAD/MAD studies we perform include high-intensity ECG recordings to support a subsequent TQT waiver, rather than perform a standalone TQT trial
These TQT studies are often embedded within complex, combined protocols. For example, Fortrea has executed TQT studies that include a SAD (Single Ascending Dose) component within the same protocol, to support selection of a supratherapeutic dose 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, lactating and post-menopausal women, etc.
Recruiting special populations is supported by our in-house recruitment team, who maintain our global databases of approximately 155,000 volunteers. 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, neuroscience, and immunology indications, demand for Phase 1b studies with patients is increasing. We excel 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 dedicated global network of clinics and a network of phase 1 partner sites with the capability to recruit and run early phase patient studies, accommodating requirements such as overnight stays and intensive PK schedules.
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 and a 100% retention rate. Our 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 across its clinics in Leeds, UK, and Dallas and Daytona Beach in the USA.
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, ethno-bridging 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.
At Fortrea, we are a global leader in conducting radiolabelled human absorption, distribution, metabolism, and excretion (ADME) studies. Our experience in this area is backed by over 500 radiolabelled hAME studies, making us the preferred partner for pharmaceutical companies seeking precise and reliable data.
Radiolabelled hAME studies are crucial for understanding the pharmacokinetics (PK) and metabolism of new drugs. Our Fortrea Madison campus is renowned for its world-leading capabilities in radiolabelled hAME studies, conducting more macrotracer and microtracer studies annually than any other CRU.
Our new, award-winning Phase I unit in Leeds, UK is now also optimised for hAME study conduct. This expanded geographical reach means Fortrea can support your radiosynthesis hAME trial in multiple locations, eliminating the complications of international radiolabelled IMP shipment.
An integrated model that delivers the right support
When it comes to developing your clinical pharmacology studies for biologics and small molecules, you need a global team that can get it done. We’ll work together to transform your preclinical safety data into robust protocols for Phase 1 safety and signals of target engagements and pharmacodynamics in both health participants (Phase 1) and patients (Phase 1b and beyond).
As one of the largest and longest established 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.
- An integrated platform of services including our own clinics, an extensive external site network, and fully dedicated project management, medical and scientific operations, clinical monitoring, and biometrics resources
- Our own dedicated CRUs in the UK (1), and USA (3)
- cGMP pharmacy capabilities in all four clinics
- Digital bedside data capture
- Routine use of Failure Modes and Effects Analysis (FMEA)
- Capabilities to study patient populations and special populations
- Robust recruitment capabilities
- Dedicated medical, scientific monitoring, advisory and pharmacokinetics teams
The capabilities to manage today’s drug development 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 has carefully evolved the design of its clinical pharmacology business to manage the ever-growing complexity of product development with end-to-end patient safety solutions.
Our integrated clinical study platform integrates Model Informed Drug Delivery (MIDD), 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:
Our Clinical Pharmacology leaders
A deep, dedicated bench of qualified pharmacists and support staff
Oren Cohen, MD
Chief Medical Officer and President, Clinical Pharmacology
Oren Cohen, MD, is President of Clinical Pharmacology and Chief Medical Officer, partnering with biopharmaceutical companies to optimize early clinical development through excellence in study design and execution. He has served in this position since Fortrea’s launch as an independent company in July 2023 following its spinoff from Labcorp.
Following a decade of translational research at the U.S. National Institute of Allergy and Infectious Diseases under the mentorship of Anthony Fauci, MD, Oren has more than 20 years of experience in various medical and scientific executive leadership roles in the pharmaceutical industry. Most recently, Oren served as Chief Medical Officer and head of Clinical Pharmacology Services at Labcorp Drug Development since 2017. Prior to Labcorp, he was Chief Medical Officer at Viamet Pharmaceuticals, where he worked closely with clinical investigators and key opinion leaders to formulate and execute clinical development programs across a portfolio, developing and executing strategy and protocol designs. Previously, he held several senior medical and operational leadership positions at Quintiles, now part of IQVIA.
Oren received his MD from Duke University and served his internship and residency at The New York Hospital, Cornell Medical Center in New York City. He completed his infectious diseases fellowship at the National Institute of Allergy and Infectious Diseases (NIAID) and stayed on to become an investigator in the Laboratory of Immunoregulation. Oren is also Consulting Professor of Medicine at Duke University Medical Center, a member of the Board of Visitors for Duke University School of Medicine and a Fellow of the Infectious Diseases Society of America. His research has been published in journals including The New England Journal of Medicine, Science, Proceedings of the National Academy of Sciences, Nature Medicine and the Journal of Clinical Investigation.
Dr Jim Bush
Vice President Medical Services, Clinical Pharmacology and Principal Investigator
Dr. Jim Bush, Vice President Medical Services, Clinical Pharmacology and Principal Investigator. Dr. Bush received his medical degree (MD) and philosophy doctorate (PhD) in regenerative medicine from the University of Manchester, UK. He holds diplomas and a certificate of completion of training in pharmaceutical medicine. He is on the UK General Medical Council Specialty Register for Pharmaceutical Medicine and is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK and a member of the Royal College of Surgeons of Edinburgh. He is also an Honorary Fellow of St George’s, University of London.
Dr Marcus Stavchansky, PharmD
Executive Director, Global Head of Pharmacy services
Dr Marcus Stavchansky PharmD, Executive Director, Global Head Pharmacy Services. Dr Stavchansky is Executive Director and Global Head of Pharmacy Services at Fortrea, based in Dallas, Texas. With over 20 years of experience in pharmacy practice—primarily in research and development—he leads global pharmacy operations across Fortrea’s Clinical Research Units in North America and the UK. As member of the Clinical Pharmacology Services leadership team, he provides strategic and scientific guidance for Phase I/Ib clinical trials, applying his specialist knowledge to drug development, GMP pharmacy services, On-Site Manufacture (OSM) of investigational drug product to clinic dose administration, and the transition from pre-clinical to first-in-human trials. He has therapeutic experience in cardiovascular disease, diabetes, obesity, asthma, and more. A registered pharmacist in Texas, Marcus also serves as adjunct faculty at the University of Texas and Texas Tech University.
Angela Hassman
Executive Director, Clinical Pharmacology
Angela Hassman is a seasoned clinical research leader with over 2 decades of experience in early-phase clinical trial operations. As Executive Director of Clinical Pharmacology at Fortrea, Angela holds global responsibilities for the oversight and strategic management of Phase I Clinical Research Units (CRUs), including sites in Madison, Dallas, and Daytona Beach in the USA, and Leeds, UK.
Her leadership spans a wide array of early-phase study types, including First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), pharmacokinetics (PK), drug-drug interaction (DDI), and radiolabeled hAME studies. Angela is recognized for her operational excellence, deep scientific understanding, and commitment to delivering high-quality data and patient safety across Fortrea’s clinical pharmacology portfolio.
Angela’s contributions have been pivotal in establishing Fortrea as a global leader in clinical pharmacology services, supporting innovative drug development programs for biotech and pharmaceutical partners worldwide.
Mark Lovern, Ph. D.
Executive Director of Medical Science Services
Dr Mark Lovern is Executive Director of Medical Science Services at Fortrea, and has 25+ years of experience in the application of model-informed drug development (MIDD). Throughout his career, Mark has led and contributed to numerous projects involving quantitative pharmacology. Prior to his present position, Mark spent over 10 years at Certara in a variety of capacities. His work history has been split between biopharmaceutical companies (GSK and UCB) and companies that support the biopharmaceutical industry (Quintiles and Certara.) In addition to modeling pharmacokinetic and pharmacodynamic data across a wide variety of compounds and therapeutic areas, Mark has also taught over 50 technical training workshops on modeling tools and methodology. His most recent therapeutic area experience has been with therapies for infectious disease, metabolic, and autoimmune disorders.
Mark was awarded a Ph. D. in Biomathematics from North Carolina State University in 1997. His favorite leisure activities include hosting dinner parties, traveling, reading, and enjoying films.
David Simpson, MSc
Senior Vice President and Managing Director, Clinical Pharmacology Services, Fortrea
David (Dave) Simpson serves as Senior Vice President and Managing Director for Fortrea’s. Clinical Pharmacology Services (CPS). CPS oversees Phase I clinical trials which involves the study of investigational drugs in healthy volunteers. In his role, Dave provides executive leadership to the CPS organization including Project Management, Phase 1 Monitoring Services and Business Operations, as well as Early Clinical Biometrics (ECB) and was instrumental in the success of Fortrea’s recent investment in state-of-the-art facilities in Leeds.
Dave provides consistent strategic leadership to Fortrea with a demonstrable track record for driving growth and competitiveness in global operations across Europe and North America with significant expertise in developing high performance teams across organizational boundaries. Within his role, Dave works to maintain enterprise wide compliance of national and local legislation. Additionally, he is responsible for cultivating ideal workplace practices and routines among CPS to streamline workflow, facilitating an environment that supports innovation and improvement.
Dave is a Certified Management Accountant (CIMA) and has master’s degree in strategic business management from The Manchester Metropolitan University. Dave is a lifelong resident of Leeds, UK and an avid supporter of Leeds United FC. He has been with Fortrea and its previous incarnations for over 35 years.
Fortrea is a leading global contract research organization (CRO) with more than 30 years’ experience helping biotechnology, pharmaceutical, medical device and diagnostics companies advance healthcare innovation that accelerates life-changing therapies to patients.