Protocol Design

Partner with a trusted team to optimize your therapeutic protocol development.

Let TD2’s experienced team of highly skilled, Oncology specialists with expertise in clinical pharmacology, pharmacokinetics, and a diverse range of cancer indications guide development of clear, scientifically driven clinical trial protocol design.

Combined with our team of clinical, medical, bioanalytical experts, biostatisticians, and drug development scientists, we partner with you to develop and deliver high-quality protocols for early phase clinical trials, covering a wide range of dosage forms and study designs. We leverage the available preclinical data to guide us in designing studies that reduce time from first-in-human to clinical proof-of-concept and ultimately therapeutic approval.

  • Accelerated titration designs
  • Study designs linking PK and PD endpoints
  • Strategic consulting, from conceptualization to development
  • Strategies for Phase I, IIa, and NDA-enabling clinical pharmacology studies

Protocol Design

TD2’s Regulatory Affairs Team engages Oncology drug development experts and strategists with proven track records of success. We utilize experienced, oncology focused medical writers, regulatory writers, and regulatory support managers to provide a customized and flexible approach across all areas of drug development.

Learn more about our Regulatory Services.

Contact our experts to help advance your development program with our trusted translational regulatory consulting team.

Contact Us

Get Started.

Have questions about how TD2 can assist with your regulatory needs? Reach out to our
expert staff today to get started.