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 scientists and clinicians carefully evaluate drug safety, tolerability and pharmacokinetics. As more information on your molecule becomes available, we’ll scrutinize development progress and deliver unique insights for decisions.

Managing complexities.

Let us manage complexity with you. 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. Learn more about Fortrea’s end-to-end patient safety solutions.

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 your drug moves toward registration, expertise across complex, specialty and standard studies can mean the difference between one partner and managing multiple vendors. You’ll have access to more than 344 beds at four sites across the U.S. and U.K. In collaboration with hospitals near our clinical research centers, we’re able to conduct high-quality, first-in-human, early clinical research in a safe and regulated environment.

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
  • Food effect
  • Drug-drug interaction
  • Radiolabeled hAME and microdose
  • Cardiac safety including definitive QTc / thorough QT (TQT)
  • Asian ethnobridging
  • Bioavailability and bioequivalence
  • Hybrid studies (healthy volunteers + patients)
  • Special populations
    • Renal-impaired
    • Hepatic-impaired
    • Elderly
    • Patients
  • Special procedures
    • Inhalation studies, bronchoscopy
    • Cerebrospinal fluid sampling
    • Ultrasound, FibroScan, CT, MRI, PET
    • Echocardiography

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