Phase I Services

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SOLUTIONS FOR ALL YOUR PHASE I NEEDS ACROSS KEY THERAPEUTIC AREAS

Our Experience:

Conducted 800+ early development studies over the past five years in healthy volunteers, patients and specialty populations

Phase I Needs:

Single ascending dose (SAD)
Multiple ascending dose (MAD)
Bioequivalence/bioavailability
Radiolabeled ADME
Renal/hepatic
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Cardiac intensive studies
Food effect
Dedicated cardiac safety
Glucose clamp studies
Ethno-bridging studies
First-in-human (FIH)
Dose selection/optimization
Proof-of-concept
Disease modeling
Medical imaging capabilities

Therapeutic Specialties:

Cardiovascular
Cell and gene therapy
Critical care
Dermatology
Endocrinology and Metabolic
Gastroenterology
Immunology and rheumatology
Infectious disease
Nephrology and renal disease
Neuroscience
Oncology/hematology
Ophthalmology
Pediatrics
Rare disease
Respiratory
Urology
Vaccine development
Women's health

Clients can access these early development CRO services as part of an integrated program in a PPD clinical pharmacology unit (CPU); ad hoc along with a client site or network site; or stand-alone functional support