We collaborate with your team to create clinical development plans (CDPs) and apply our regulatory expertise, scientific insight, and bioinformatics experience to chaperone your product through the entire approvals process.


  • CCSA has developed databases containing more than 30,000 entries on potential cancer preventives
  • We provide critical evaluation of nonclinical efficacy and toxicity testing models as well as potential uses for medical devices
  • We develop and apply structure-activity relationships (SARs) and mechanism of action evaluations for drug modality and safety


  • CCSA plans, organizes, and leads pre-submission and other planning meetings with regulatory agencies
  • We have authored more than 50 CDPs for cancer prevention and treatment alone
  • We leverage our expertise and experience to support development strategies for a wide range of products from targeted small molecules to immunotherapeutics and advanced technology platforms

Biomarkers and companion diagnostics

  • CCSA developed the first Master IND approved by FDA
  • We have designed large phase 2/3 adaptive and companion diagnostic investigational protocols
  • We partner with pharmaceutical and biotechnology entities, NCI, FDA, academia, and non-profits in support of public-private partnerships such as the NCI Center for Strategic Scientific Initiatives and The Biomarkers Consortium