PRECISION AND QUALITY

Clinical Pharmacology

Clinical pharmacology provides the link between preclinical data and new treatments for patients. Whether it is your first-in-human study, an exploratory biomarker study or a study needed for your NDA package, Fortrea’s clinical pharmacology-dedicated scientists and clinicians deliver precise drug safety, tolerability, pharmacokinetic and pharmacodynamic data. As more information on your molecule becomes available, we’ll 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:

Rely on our experience to manage complexities

Let us manage complexity with you with end-to-end patient safety solutions. Our integrated clinical study platform is built to handle multisite hybrid study designs, rapid-sequence dose escalations, sophisticated biomarker or imaging exploratory endpoints, extemporaneous investigational product preparation and more. And, 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.

Support your early phase development with strategic CRU locations

As your drug moves toward registration, expertise across complex, specialty and standard studies can mean the difference between one partner and managing multiple vendors. With Fortrea, you’ll have access to more than 340 beds at four sites across the U.S. and the U.K. In collaboration with a network of specialized external sites, we’re able to conduct high-quality, early phase clinical research in a safe and regulated environment.

Take a virtual tour of our Clinical Research Units (CRUs)

Expect flexible and tailored partnering

When it comes to developing your clinical pharmacology studies for biologics and small molecules, you need a global partner that can get it done. As a team, we’ll work together to transform your preclinical safety data into robust protocols for Phase I safety and signals of target engagement and pharmacodynamics in healthy subjects and patients.

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:

First-in-human (FIH) single ascending dose / multiple ascending dose (SAD/MAD)
Food effect
Drug-drug interaction
Radiolabeled hAME and microdosing
Cardiac safety including definitive QTc/thorough QT (TQT)
Ethnobridging studies
Bioavailability and bioequivalence
Hybrid studies (healthy volunteers and patients)
Special populations
Renal-impaired
Hepatic-impaired
Elderly patients
Special procedures
Inhalation studies, bronchoscopy
Cerebrospinal fluid sampling
Ultrasound, FibroScan, CT, MRI, PET
Echocardiography

Your needs. Our solutions.

As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies to drive healthcare innovation throughout the world.