STRATEGIC PLANNING FOR PRODUCT DEVELOPMENT

 

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

 Discovery

  • 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
Regulatory

  • CCSA plans, organizes, and leads 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 organics to immunotherapeutics
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