Consulting

OTD provides independent consulting services in oncology early drug development, from study design through clinical development programs.

  • Review of proposed clinical studies, resources, and timelines
  • Due diligence of pharmacology, toxicology, clinical, and CMC data, and regulatory affairs to guide preclinical and clinical development of novel anticancer drugs
  • Lead positioning based on our insights into evolving patterns of cancer treatments
  • Assist in the preparation of a clinical development plan and regulatory strategies
  • Recommend regulatory strategies for global product registration
  • Design clinical and regulatory strategies to achieve expedited marketing approval and rapid adoption in the clinic
  • On-site review of medical source data from clinical trials and compassionate-use programs

 

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