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 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.
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
- Elderly patients
- Special procedures
- Inhalation studies, bronchoscopy
- Cerebrospinal fluid sampling
- Ultrasound, FibroScan, CT, MRI, PET