Clinical Pharmacology to Accelerate Global Drug Development
We support global drug development through integrated clinical pharmacology and pharmacometric expertise. Our team provides biometrics (including SAS programming and NCA) and advanced translational and clinical modeling to enable informed, data-driven decision-making across development programs.
Following the integration of A2PG, our global clinical pharmacology team offers expanded expertise to support programs across a broad range of therapeutic modalities.
Noncompartmental PK/TK Analysis & Reporting
GLP-compliant (21 CFR Part 11) noncompartmental PK/TK analysis to characterize pharmacokinetic properties and support clinical and toxicology study reporting.
Statistical Programming
SAS programming and generation of SEND and SDTM datasets, including tables, listings, and figures for clinical study reports and regulatory submissions.
Translational Modeling & Simulations
Integration of nonclinical pharmacology, DMPK, and toxicology data to support clinical PK/PD projections and first-in-human dose selection.
Pharmacometrics
Population PK/PD modeling and exposure¨Cresponse analyses to support dose selection, trial design, and evaluation of efficacy and safety.
Quantitative Systems Pharmacology (QSP)
Mechanistic, multi-scale modeling to characterize relationships between targets, pathways, disease biology, and therapeutic interventions to support optimization.
Expert Consultation
Scientific and strategic consulting to support trial design, development decisions, and regulatory interactions, with flexible engagement options, including hourly consulting.
How Can We Help?
We support informed, data-driven decision-making across your clinical development program, providing the expertise needed to guide critical development and regulatory decisions.
Accelerating Drug Development Through Expertise
Our experienced team supports efficient trial design, development strategy, and regulatory interactions to help advance programs across global markets.
We develop pharmacometric models to characterize pharmacokinetics, efficacy, and safety, and apply simulation-based approaches to evaluate clinical scenarios and enable informed, data-driven decision-making. Applications include dose selection, trial design, patient selection, regulatory interactions, and support for NDA, BLA, and MAA submissions.
Model Informed Drug Development (MIDD)
