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