Why inviCRO Contract Research?

inviCRO’s Contract Research and Image Analysis divisions combine expertise in imaging study design and execution with advanced high-throughput image processing and analysis. inviCRO works with drug development teams to integrate standard and novel anatomical and molecular imaging methods into research programs to assess drug pharmacokinetics, distribution, targeting and efficacy, explore the mechanism of action, correlate to other efficacy or pharmacodynamics biomarkers and guide candidate and dose selection. inviCRO’s team combines expertise in imaging science, physics, engineering, mathematics, neuroscience, biomedical engineering and statistics to address biological questions with imaging tools.

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Full-scale image study management, 500+ studies to date , 100+ compounds radiolabeled,  processing 35,000+ scans per year , 10,000,000+ regions of interest

CR Steps2

Study design

Study design

  • A-Z study design for major imaging modalities (SPECT, PET, MRI, X-Ray CT, Optical).
  • Independent literature review.
  • Tracer selection and/or isotope selection and radiolabeling strategy for biologics.
  • Pharmacokinetic modeling for tumor targeting agents aiding in the prediction of preclinical and clinical imaging experiments and enriching study power and time point design.
  • Experience with a wide variety of animal species (rodents, rabbits, NHP, etc…) and models (xenograft and orthotopic tumor models).
  • Ability to assess pharmacokinetics and distribution of radiolabeled small molecules, peptides, proteins and antibodies.
  • Ability to assess in vivo transport/kinetics, target specificity and off-target accumulation.
  • Estimates of study power (group sizes) provided to better ensure achievement of a statistically robust result.
  • Ability to assess effect of mass dose on organ/tissue uptake and retention.
  • Application of off-the-shelf and custom pharmacokinetic models to guide pre-clinical study design and guide clinical translation.

Study execution

  • Extensive radiochemistry and radiolabeling expertise.
  • Extensive method development, including isotope selection and chelation chemistry.
  • Integration of imaging and ex vivo analysis to bridge gaps in imaging resolution and sensitivity.
  • Imaging system quality control and calibration prior to study commencement.
  • Contract research studies are conducted under the control of inviCRO SOPs, which can be modified to meet sponsor needs.
Study execution
Image data access

Image data access

  • Near real-time data access.
  • Preliminary image analysis and identification of region of interest.
  • Bank-level secure communication between sponsor and server.

 

Collected study data integrates seamlessly with inviCRO’s software platforms. Clients are kept apprised of study progress in near real-time through a remote interface with the web-based iPACS® system.

Read more about iPACS

Data analysis

  • High-throughput processing with fast turnaround times.
  • Advanced protocols for tumor, heart, lung and brain analysis.
  • Quantitative whole body and sub-organ analysis.
  • Novel, study-specific advanced analysis method and algorithm development.
  • Intra- and inter-study analysis.
  • Advanced statistical analysis and PK modeling.
  • Secured web-based access to all data, plots, images movies and reports.
Study execution