Contract Research and Development
iC42 Clinical Research & Development is a regulatory compliant laboratory (GLP, CAP and CLIA certified) and an extension of one of the leading Medical Schools in the United States, the University of Colorado and its Department of Anesthesiology.
iC42 has full and instant access to the University of Colorado’s resources and expertise. Our scientists, who are highly qualified with strong academic track records and extensive industry experience, facilitate innovative projects and strategize developments that are far beyond the capabilities and capabilities of most established Commercial Research Organizations.
iC42 is committed to advancing individualized medicine by examining the unique biology of an individual to assess truly personalized treatments. Our state of the art facility provides integrated solutions to systems biology and is located at Colorado’s Fitzsimmons Bioscience Park.
Our services include:
- Highly sensitive HPLC, LC-MS/MS, and GC-MS-based bioanalytics •
- Complex assay development & validation
- Sample analysis of pre-clinical and clinical studies in a GLP compliant, CAP accredited, CLIA certified environment
- Quantification and pharmacokinetics of drugs & metabolites
- Pediatric pharmacology
- Generation and isolation of drug metabolites, structural identification & enzyme kinetics
- Clinical Therapeutic Drug Monitoring
- Complete PK/PD package managed under one roof
- Molecular marker discovery and development including validation, verification, and qualification
- Consulting & strategic research partnerships
iC42 promotes and enhances research through the Colorado Center for Transplantation Care (CCTCARE). CCTCARE has been designed as a unique, comprehensive transplantation center that not only closely integrates basic, translational and clinical research, clinical services, educational and training programs, as well as community and outreach programs but that has also been designed to collaborate with other institutions and serve as a national and international resource for transplant research.
It is CCTCARE’s vision to improve transplant patient care by advancing transplantation and its associated fields through its own highly integrated and innovative research, drug and diagnostics development programs.
At iC42, not only do we think big but we also think small. Surprisingly, little research has been carried out examining pediatric pharmacology. The primary reason for this is a lack of sensitive drug assays that require very low sample volumes.
Currently, iC42’s most exciting pediatric pharmacokinetics project is the development of small volume sampling techniques that measure accurate drug levels from a single drop of blood. These novel and highly sensitive assays detect the drug, their metabolites and also the biomarkers. This current research has the potential to revolutionize pediatric drug studies and patient monitoring by enabling us to extract reliable data from miniscule samples obtained from our smallest subjects.
Reflecting our commitment to pediatric research, iC42’s co-director Dr. Jeffrey Galinkin from The Children’s Hospital in Aurora/ Denver, is designing and conducting pediatric pharmacokinetics/ pharmacodynamics studies to advance pediatric pharmacology using iC42’s novel and cutting-edge bioanalytical and translational technologies. Dr. Galinkin is also the founder of the Colorado Center for the Advancement of Pediatric Pharmacology (CCAPP). iC42 functions as CCAPP’s core bioanalytical laboratory.
iC42 is a unique clinical research and development facility that combines quantitative mass spectrometry (drugs, drug metabolites, other small molecules and large molecules, endogenous compounds), metabolic and protein profiling technologies in a regulatory compliant environment under one roof.
See why we are the source for all of your research and development needs:
Our Clinical Research Partner
CPC Clinical Research is an Academic Research Organization and one of iC42’s strategic partners. This partnership allows us to coordinate and manage clinical trials, from phase I healthy volunteer trials to international multi-center trials. CPC Clinical Research is an affiliate of University of Colorado School of Medicine and has carried out highly successful full-service clinical research management for more than 20 years. CPC provides comprehensive clinical trial management services including:
- Global Project Management
- Site Monitoring
- Medical Affairs/Pharmacovigilance
- Regulatory Services
- Biostatistics and Data Management
- Medical Writing
