The principal focus of our clinical research program is to serve the health care industry through providers, CROs, pharmaceutical companies and other life science enterprises in support of observational/registry trials and Phase II through Phase IV clinical studies. The program’s uniqueness and attractiveness lies in offering distinct services to companies in need of clinical trial support. In addition to patient and physician access through multiple clinical trial oncology practices, we are capable of offering full site management services to health care providers, trial sponsors as well as clinical research organizations.
Our clinical research program can be best described as a multi-function clinical research site management organization that performs the administration, regulatory, and management functions of clinical trials in coordination with its clients to determine the safety, efficacy and clinical usefulness of treatment therapies, investigational stage pharmaceuticals and companion diagnostic tools.
Clinical Research Services
The research program focuses on five areas:
- Therapeutic Drug Evaluation
- Oncology Clinical Study Management (Medical & Radiation Oncology)
- Radiotracer Development
- Physician Clinical Research Training
Therapeutic Drug Evaluation: CBR is significantly active in the evaluation of therapeutic drugs. CBR currently provides oversight and principal investigators for over 20 open clinical trials and over 90 in follow up spanning major disease sites such as Breast, Lung, Colon, and many other cancer diagnoses. These trials cover curative, first and second line therapeutics.
Oncology Clinical Study Management: We specializes in managing oncology clinical trials from start to finish in both medical and radiation oncology. As members of ECOG, CTSU, RTOG/NRG Oncology we manage the complete spectrum of clinical trials from cooperative groups to pharmaceutical sponsors to investigator directed clinical trials. These clinical trials vary in range from observational/registry trials to Phase II – Phase IV trials.
Pharmacogenomics: Medical diagnostics and therapeutics will experience a significant shift over the next 2-10 years as the old “one treatment fits all” model is replaced with a more personalized treatment and disease tracking system based on genomic make-up. Patients will be grouped into subsets based on the presence or absence of specific gene mutations for each disease. Today, a growing area of interest and research is therefore de-coding the relevance of DNA profiles. We currently participates in a biobank blood draw trial that is soon to be significantly expanded to cover a wide breadth of diagnoses.
Radiotracer Development: With access to an on-site cyclotron and radiochemistry system, we plan a program to assist in the development of new radiolabeled tracers and biomarkers for use in companion diagnostics, assessing pharmacological effects, molecular drug delivery efficiencies and drug retention/uptake studies. We have participated in one Phase II trial for a new PET myocardial perfusion imaging agent and was recently opened the Phase III of this same agent.
Physician Clinical Research Training: As clinical research regulations continues to grow more complex it is critically important that principal investigators are up to date on all regulations and good clinical practices. We provide educational programs to assure that principal investigators are informed and educated on all aspects of new clinical research regulations and good clinical practices. Whether one time sessions or monthly meetings, we meet the needs of our many physician clients.