Summit is skilled at designing and implementing preclinical studies, from animal models of disease to IND-enabling toxicology studies. Summit has an extensive database of external laboratories with which it collaborates on a regular basis. Outsourcing of preclinical studies is an effective and desirable strategy for many biotechnology companies. Summit preclinical services include:

• Pharmacology and Toxicology Studies
  • Vendor identification
  • Protocol preparation
  • Contract negotiation
  • Study monitoring
  • Regulatory interpretation 
• Pharmacology
  • In vitro profiling
  • In vivo animal models (e.g. oncology, CV, CNS)
  • Safety pharmacology
  • Combination pharmacology/toxicology studies
• Toxicology
  • General toxicology (acute through carcinogenicity)
  • Genetic toxicology
  • Reproductive toxicology
  • Special assessments & mechanistic studies
  • Issues management
• PK / ADME
  • In vitro metabolism
  • In vivo pharmacokinetics
  • Tissue distribution/mass balance
  • Bioanalytical and analytical methods development & analyses