Pioneering Clinical Pharmacology & Drug Development.
Pioneering Clinical Pharmacology, Pharmacometrics & Pre-Clinical Safety
Inncelerex specializes in supporting drug development across all stages, including: candidate selection, toxicology, pre-clinical, early clinical development, late-phase clinical trials, drug registration and post marketing requirements.
Our integration of scientific and regulatory expertise in clinical pharmacology, modeling and simulation, translational medicine, toxicology and pre-clinical safety offers comprehensive solutions which serve to enhance program design, execution and strategic decision-making.
Our ability to manage a broad spectrum of studies, including clinical pharmacology, pharmacometrics, pharmacodynamics, toxicology, and ADME studies, ensures program efficiency and precision.
KEY EXPERTISE
CLINICAL PHARMACOLOGY
Our extensive experience in clinical pharmacology and early development provides the expertise to design an efficient program and take development candidates from pre-IND through various phases in clinical development.
PHARMACOMETRICS, MODELING & SIMULATION
Our experience in Modeling and Simulation is coupled with clinical pharmacology that provides a seamless solution for clients to save time and cost of development and guide the program at critical decision points.
PRE-CLINICAL SAFETY AND TOXICOLOGY
Broad experience in design, tailoring and overseeing pre-clinical safety investigational and GLP studies to enable INDs, and support entry into clinical phase and the full clinical development.
TRANSLATIONAL MEDICINE
We are a team of experienced drug development experts who utilize and maximize gain from any data generated in early in development programs and look for signs and markers that would guide decision-making, program design and endpoint selection.
DRUG DEVELOPMENT & PROGRAM TECHNICAL OVERSIGHT
We expertly design, oversee, and interpret a wide range of studies, including pre-clinical, early and late-phase clinical trials. Our focus areas encompass pharmacokinetics, pharmacodynamics, efficacy, drug interactions, bioequivalence, first-in-human studies, TQT, and renal/hepatic impairment, along with age and gender studies. These expertise extends to Phase 2 and Phase 3 trials as needed.
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