The Center for Translational Medicine provides no-cost consultations and offers a wide range of expert, high-quality, cost-effective preclinical development services. Laboratory services are provided to internal and external clients on a fee-for-service basis.
- Expert scientific review and evaluation of new development concepts and projects.
- Consultation regarding regulatory requirements, study designs and preclinical development plans.
- Design and conduct preclinical studies for:
- In vitro and in vivo safety and efficacy
- Dose, schedule, route of administration and formulation optimization
- Single-dose, repeat-dose and GLP toxicology
- General and safety pharmacology
- Pharmacokinetics and toxicokinetics
- Support for FDA meetings and filings; IND and IDE development and submission.
- Coordinate development activities such as bioanalytical method development; stability testing; and pilot, scale-up, and GMP manufacturing of clinical product.
- Support for Phase I clinical trial design and implementation.
Studies are designed, conducted and reported in compliance with SOPs, IACUC and regulatory requirements.
These services are also available through our Partnership Program.