Full service, scientifically driven Phase I-IV CRO, Princeton, NJ. CRO services include: Study Site Monitoring, Project Management (utilizing proprietary web based STUDYTRACKERTM), Data Management, SAS, Medical Writing, Pharmacovigilance, Biostatistics, PK/PD analysis and modeling, Regulatory Guidance, Strategy, Electronic Submissions.
A 72 bed Phase I-II Clinical Research Facility, Hackensack, NJ conducts inpatient and outpatient study designs including: FIHT, PK/PD, P-O-C/M, QTc, BA/BE, DDI, Drug-Alcohol, Special Populations.
Additional services (Frontage Laboratories, Malvern, PA, Shanghai, China): GLP Method Development and Validation, In-Vitro Half Life Studies, Formulation and Process Development, GMP Clinical Supplies - APIs, Stability Studies, GLP Dosing, Master Batch Record Development.