What clinical & quantitative solutions does API provide?
From preclinical research to clinical trials, our team of leading pharmacologists, biostatisticians and bioinformaticians delivers comprehensive, data-driven solutions. We work closely with you to customize strategies that align with your goals, ensuring a streamlined development process that maximizes efficiency and impact. Whether it’s optimizing study designs, advancing pharmacokinetic analysis, or leveraging AI for biomarker selection, our services empower you to bring your innovation to market safely and effectively.
Clinical & Quantitative Solutions Services
Preclinical ADME and Translational Pharmacology
Comprehensive support for preclinical and translational pharmacology, from PK analysis to biomarker selection.
- Pharmacokinetics (PK) and Toxicokinetics (TK): Ensure precise first-in-human (FIH) and allometric scaling.
- Safety Assessments: Evaluate No Observed Adverse Effect Level (NOAEL) and Minimum Anticipated Biological Effect Level (MABEL).
- Bioinformatics and Biomarker Selection: Leverage multi-omic approaches for pharmacodynamic and disease-specific biomarkers.
Biostatistics Services
Expert biostatistical services covering study design, analysis, and data visualization.
- Clinical and Preclinical Study Design: Tailored support for the unique needs of each life sciences client.
- Statistical Analysis Plans: Power and sample size calculations, data summaries, adverse event analysis, and endpoint results presentations.
- Shiny Apps Development: Customized tools for effective data visualization and analysis.
- Data Review: Missing data imputation (LOCF) and error detection, including outliers and out-of-range values.
- Statistical Programming: CDISC-compliant dataset programming, Analysis Data Model (ADaM) and Study Data Tabulation Model (SDTM) development, and generation of tables, listings, and figures (TLFs) for reports.
- Dose-Finding and Dose-Response Analysis: Focused on Phase 1 clinical trials and other therapeutic evaluations.
- Support for DSMB/DMC: Preparation of data outputs for Data Safety Monitoring Boards (DSMB) or Data Monitoring Committees (DMC).
Clinical Pharmacology: Phase 1 – 3
Understanding drug interactions is essential for developing safe and effective therapies. We leverage advanced pharmacokinetics, Bayesian modeling, and clinical trial simulations to optimize dosing and outcomes.
- Clinical Study Design, Planning, Analysis, Reporting: Customized study designs that encompass first-in-human studies, bioavailability and bioequivalence evaluations, drug-drug interaction assessments, food effect studies, QT interval prolongation evaluations, organ impairment analysis, ethnic bridging strategies, radio-labelled mass balance for ADME, and pediatric pharmacokinetics/pharmacodynamics.
- PK Analysis Plan: Rich sampling pharmacokinetics using non-compartmental and compartmental approaches, with PK-PD correlations (direct and indirect) using Phoenix WinNonlin™.
- Population Pharmacokinetics (Sparse Sampling): Advanced modeling with NonMem.
- Physiologically Based Modelling (PBPK): PBPK-PD analysis with Gastroplus™ and PKSim.
- Therapeutic Window and Dose-Response: Clinical trial simulations for optimized dosing.
- Disease State Modeling: Comprehensive modeling for various disease states to inform clinical strategies.
- Gap Analysis & Clinical Pharmacology Plan: Idecntifying key areas for improvement to support robust clinical pharmacology plans.
Quantitative Systems & Translational Pharmacology (QSP & QTP)
Data-driven pharmacology modeling and mechanism of action insights to predict clinical outcomes.
- Modeling and Systems Pharmacology: Use advanced network analysis and disease models to predict new molecule interactions and clinical outcomes.
- Mechanism of Action in Humans: Detailed insights into drug mechanisms through systems and molecular pharmacology.
- Quantitative Translational Pharmacology: Leverage data-driven strategies to translate findings from models to human applications, optimizing therapeutic impact.
Bioinformatics
Multi-omics and molecular data integration for target and biomarker selection, with advanced spatial and bulk analysis.
- Multi-Omics: Expertise in genomics, transcriptomics, lipidomics, proteomics and microbiome analysis.
- Target and Biomarker Selection: Identify critical targets and biomarkers for therapeutic development.
- Spatial and Bulk Data Analysis: Advanced spatial single-cell and spot-level RNA sequencing, alongside bulk data analysis.
- Gene-Set and Molecular Network Analysis: Integrate gene expression profiles using complex molecular interaction networks for deeper insights.
- Intratumor Heterogeneity: Quantify and visualize tumor diversity at the molecular level.
Artificial Intelligence
AI-driven machine learning solutions for biomarker selection, patient stratification, and clinical study design. Our customizable approach allows us to tailor solutions to your project’s specific needs.
- Machine Learning & Artificial Intelligence Consultation: Problem statement and solutions.
- Machine Learning & Deep Learning: Advanced algorithms for data analysis and predictions.
- Biomarker and Patient Selection: Identify biomarker patterns and predict patient responders for personalized therapies.
- PK/QSP Integration: AI can be applied independently or in conjunction with pharmacokinetic and quantitative systems pharmacology methods for enhanced decision-making.
Seamless Integration with Clinical & Quantitative Solutions and Regulatory & Quality
Our Discovery & Development team works hand-in-hand with our Clinical & Quantitative Solutions and Regulatory &m Quality team to provide comprehensive, data-driven strategies. Together, we ensure your journey from concept to market entry is seamless, whether you’re working on pharmaceuticals, natural health products, medical devices, or diagnostics.
Regulatory & Quality
We bridge the gap between academia and industry by providing the full expertise, services, and infrastructure of a life sciences company.
Discovery & Development
We specialize in guiding companies through preclinical, clinical, and market safety phases, providing expert support at every stage of development.
CDMO Services
We deliver flexible solutions for clinical and commercial manufacturing.
Meet Our Senior Leaders and Contacts
Corinne Campanella
VP, Quantitative Solutions
Read bioabout Corinne Campanella Corinne Campanella
VP, Quantitative Solutions
Corinne is a seasoned Clinical Pharmacologist with over 25 years of diverse experience in the pharmaceutical industry. She has held key roles in early-phase clinical development and medical safety across North America and Europe, working with leading companies like Sanofi, GSK, UCB, Biovail, Apopharma.
Corinne brings a deep expertise in early-phase clinical development and a strategic perspective that spans from lead selection to late-stage development and a keen ability to build and lead high-performing cross-functional teams. In her most recent role as Director of Clinical Pharmacology at Certara, she partnered with clients to develop and optimize clinical pharmacology strategies essential for successful drug development. Corinne holds a PharmD from the University of Paris-Cité in France and a Master of Science in Pharmacokinetics from the University of Alberta in Canada.
Scott Campbell
Associate Director, Quantitative Solutions
Morteza Hajihosseini
Biostatistical Data Scientist
Located in one of Canada’s Fastest-Growing Life Sciences Hubs
Located in Edmonton, Alberta, API sits at the heart of one of Canada’s fastest-growing life sciences ecosystems. Our region is experiencing a surge in investment, with new infrastructure, expanded research capacity, and a strong pipeline of talent. Anchored by globally recognized institutions like the University of Alberta, Life Sciences Campus at the Edmonton Research Park and surrounded by a growing community of startups and a tightknit entrepreneur community, Edmonton offers a uniquely collaborative environment for innovation.
Edmonton is also a key part of the Canadian Critical Drug Initiative (CCDI), a nearly $200 million project led by our team at API in partnership with the University of Alberta. Through the CCDI, we’re developing an integrated research, commercialization and manufacturing cluster within the Edmonton Metropolitan Region.
As a Canadian-based CRO and CDMO, we also offer cost advantages and access to international markets—making us an ideal partner for both domestic and global companies looking to scale their therapeutic innovations.
The Canadian Critical Drug Initiative
Learn more about our services for different therapeutic areas
Pharmaceuticals & biologics
Discover how we can help you accelerate the drug development process.
Medical devices & diagnostics
Learn how we can help you navigate the intricacies of advanced medical technology.
Natural health products
Find out how we can empower your consistent NHP development.
Health technologies
See how we support the evolving landscape of health technologies.
Ready to take your life sciences innovation to the next level?
Contact us today for a free discovery consultation to determine how we can bring your idea to market together.
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