Clinical Pharmacology Studies Only Get More Complicated.
Introducing a drug into the human body for the first time is an important milestone. With so much at stake, human safety and early efficacy are now driving more go / no-go decisions than ever before. We focus on two critical aspects of your study — 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 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. Your 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 United States and Europe. As one of the largest early-stage clinical research organizations in the world, you’ll find a study to meet your needs.
- SAD / MAD (single-ascending-dose/Multiple-ascending-dose)
- Adaptive clinical protocol design
- Cardiac safety including definitive QTc/thorough QT (TQT)
- Human ADME – 14C Radiolabeled
- Muscle biopsy
- Absolute bioavailability
- Age and gender
- BA / BE (bioavailability/Bioequivalence studies)
- Dose proportionality
- DDI (drug-drug interaction)
- Food effect
- PK / PD (clinical Pharmacokinetics/Pharmacodynamics)
- Special populations and hospital relationships