Integrated, seamless studies.
Our experience spans more than 30 years and 1,300 Phase I studies, including FIH (SAD/ MAD), DDI, TQT, bioavailability, food effect, and 14C ADME studies.
Accelerate your study startup at our clinical units in Miami (U.S.) and Nottingham (U.K.) with industry-leading IRB/EC and CTA approval timelines. In addition, 99 percent of our studies start on time, 98 percent enroll with full cohorts, and 99 percent of our subjects are retained throughout. If you need to access a challenging healthy volunteer population for your study, we rapidly recruit large cohorts of volunteers.
Leverage our experience in all dosage forms, and save time with our strategic approach. For over 30 years, our drug product teams have helped formulate compounds and develop scalable drug products to transition customers from Phase I into Phase II patient trials and beyond.
Our fully integrated programs are led by experienced project managers alongside industry-leading Phase I medical directors who are experts in first-in-human (FIH) and drug-drug interaction (DDI) and thorough QT (TQT) studies.
We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier. How? Our in-house data sciences team rapidly delivers clinical data and insights to move you on to the next milestone as fast as possible.
Experience and Study Types
Over 30 years of expertise to seamlessly deliver your studies with the highest quality service and speed.
- FIH (single ascending dose [SAD]/multiple ascending dose [MAD])
- Relative bioavailability/pharmacokinetics
- Drug-drug interaction (DDI)
- Food effect
- Thorough QT (TQT)/cardiac safety
- Bioequivalence
- Biosimilars
- 14C ADME/mass balance
- Isotopic labeling
- Gamma scintigraphy
- POC
- Pharmacodynamics/biomarkers
- Japanese bridging
Explore Our Global Clinical Pharmacology Facilities
Our Miami, FL, USA Clinical Pharmacology Unit:
- 144-bed clinical unit with dedicated FIH wards
- Database of more than 26,000 healthy volunteers
- On-site compounding pharmacy with clean room for aseptic products (USP 795/797/800 compounding pharmacy
- Recruitment for special subject populations aged 65+, post-menopausal, male and female of non-child bearing potential, females taking oral contraception
- All clinical staff are Basic Life Support (BLS) certified and licensed EMTs, nurses and physicians are Advanced Cardiac Life Support (ACLS) certified
Our Nottingham, UK Clinical Pharmacology Unit:
- Responsible for approximately 25% of Phase I trials submitted to the MHRA each year
- 85 beds across 6 wards, including a dedicated 14C ADME ward and laboratory
- Database of more than 7,000 healthy volunteers
- On-site pharmaceutical laboratories and GMP manufacturing
- All clinical staff are ILS trained at a minimum, and all medical staff are ALS trained