Clinical Pharmacology that Accelerates Global Drug Development

Crystal Bio Solutions delivers integrated biometrics, pharmacometrics, and modeling and simulation to focus your development, reduce risk, and speed decisions. Our global team supports early nonclinical translation through late-stage clinical programs across various drug modalities. Services include SAS programming, CDISC deliverables, NCA, population PK/PD, QSP, and inspection-ready documents for regulatory submission. A2PG is fully integrated into our global clinical pharmacology group.

Noncompartmental PK/TK Analysis and Reporting GLP and 21 CFR Part 11 compliant NCA for early characterization of PK and TK. Standard outputs include concentration-time plots, exposure metrics, accumulation and linearity assessments, and eCTD-ready tables, figures, and narratives for tox reports and CSRs.

Statistical Programming

End-to-end SAS programming with CDISC compliance: SEND for nonclinical, SDTM and ADaM for clinical, TLF packages, define.xml, reviewer guides, and validation with Pinnacle 21 to support IND, CTA, and BLA/MAA submissions.

Translational Modeling and Simulations Quantitative integration of nonclinical pharmacology, DMPK, and toxicology to project clinical PK/PD, set the first-in-human dose, evaluate DDI and QT risk, and test scenarios that inform study design and enrollment strategy.

Pharmacometrics Population PK/PD modeling and exposure-response analyses for dose selection, enrichment, endpoint justification, covariate and subpopulation assessment, and trial simulations that de-risk pivotal plans and regulatory reviews.

Quantitative Systems Pharmacology (QSP) Mechanistic, multi-scale models that link target engagement to pathway, disease biology, and clinical endpoints. QSP supports indication selection, biomarker strategy, and optimization of therapeutic interventions.

Expert Consultation

Hands-on guidance from senior scientists for study design, SAP alignment, decision frameworks, and authority interactions. Outputs are inspection-ready and aligned with ICH expectations.

Pharmacometric model diagrams and PK plots used for model-informed drug development.

Model Informed Drug Development (MIDD) We build quantitative pharmacostatistical models that describe PK, efficacy, and safety, then run simulations to compare clinical scenarios. Outputs inform first-in-human dose, adaptive or enrichment strategies, endpoint selection, and patient or indication prioritization. We also prepare briefing packages and responses for authority meetings and support NDA, BLA, and MAA filings.

Clinical pharmacology team collaborating on global drug development strategy.

Global Drug Development and Launch Teams in the US, China, and EU coordinate with our regulatory, clinical, and bioanalytical groups to deliver coherent global plans. Services cover regional strategy and bridging, labeling and claims planning, and launch-readiness activities, so sponsors move from pivotal data to approval with confidence.

Clinical Pharmacology that Accelerates Global Drug Development

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