Safety Pharmacology

Safety Pharmacology studies evaluate the risk of adverse or life-threatening organ system effects posed by new pharmaceutical products and are a required and essential part of many IND-enabling drug safety programs. Given their importance, some Sponsors also supplement their early drug development work with exploratory Safety Pharmacology studies to enable critical project go/no-go decisions.

Sinclair delivers the highest quality safety pharmacology data to our Sponsors that identify and characterize potential functional safety risks throughout the drug development timeline.

Sinclair Research provides:

  • Core battery assessments
  • Integrated and standalone in vivo safety pharmacology assessments
  • A consultative, expert approach to the unique needs of each client and compound
  • Experimental designs to evaluate Safety Pharmacology endpoints
  • Flexibility and experience to support the evaluation of specialized endpoints in your Safety Pharmacology studies

Why partner with Sinclair Research?

As one of the largest nonclinical CROs in North America, Sinclair Research’s scientific and technical expertise can provide you with the Safety Pharmacology services you need, the data you expect, and the customer experience you deserve! Contact our team to discuss your upcoming research and meet with our scientific experts to discuss how to reach your next development milestone.

Our Safety Pharmacology services include:

Cardiovascular System

  • Remote telemetry monitoring of hemodynamics and electrocardiography in freely moving animals, including all contemporary models, with calibrated continuous data collection, using appropriate analytical methods for quantitative and qualitative data along with expert interpretation
  • Cardiac and pulmonary hemodynamics, along with advanced electrophysiology also available

Respiratory System (as part of the cardiovascular study)

  • Rate, volume, and supplemental derived respiratory mechanic parameters
  • Remote, calibrated telemetry monitoring in freely moving animals with continuous data collection

Central Nervous System

  • Functional Observational Battery (FOB) for small animals
  • Veterinary neurological assessments for large animals

ICH S7A & S7B Guidelines

Sinclair Research provides a full range of functional testing services, including Safety Pharmacology studies with fully validated systems in accordance with International Conference on Harmonization (ICH) Guidelines (S7A, S7B).

Core Battery Safety Pharmacology Studies

Sinclair Research conducts Core Battery Safety Pharmacology Studies utilizing state-of-the-art equipment while our partners at CorDynamics support the data interpretation backed by decades of cardiovascular Safety Pharmacology experience over hundreds of projects.

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