Transition your compounds seamlessly into the clinic with a program analysis focused on risk-mitigation and evaluations of progress. As a TD2 client, you’ll get a comprehensive plan outlining the best path toward first-in-man phase I clinical trials—all based on our experts’ deep experience and calculated and careful assessments of your project. This includes:
- Safety package/plan, including toxicology, pharmacokinetics and pharmacology
- Chemistry, Manufacturing and Controls (CMC), including bioanalytical methods, drug formulation, manufacturing and stability
- A full regulatory package
- Clinical trial designs with your approval path(s) in mind, including well-characterized patient populations, safety, feasibility of proposed dose, route of administration, inclusion/exclusion criteria, incorporation of appropriate biomarkers and any other special program requirements
With this plan in place, our drug development project managers facilitate the entire program from the pre-investigational new drug (IND) stage through clinical development. By having one project team responsible for program navigation from preclinical into clinical development, you’ll enjoy a seamless transition at every juncture of your drug’s journey.