Clinical pharmacology studies only get more complicated
Let us manage complexity with you. Our integrated drug development 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.
Partnering with you at the moment of truth
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.
The best clinical pharmacology drug development services are built for flexibility
Clinical pharmacology is the link between the preclinical data and the targeted population. Our team of scientists and clinicians put principles into action by closely monitoring testing, including preliminary evaluation of drug safety, tolerance and pharmacokinetics. As more information on your molecule becomes available, we’ll scrutinize development progress and deliver unique insights for decisions.
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 316 beds at four sites across the U.S. and U.K. 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 human AME and microdose
- Cardiac safety including definitive QTc/thorough QT (TQT)
- Asian ethnobridging
- Bioavailability and bioequivalence
- Hybrid studies (healthy volunteers + patients)
- Special populations
- Special procedures
- Inhalation studies, bronchoscopy
- Cerebrospinal fluid sampling
- Ultrasound, FibroScan, CT, MRI, PET