Our CanBioPharma Consulting team has extensive experience in the safety assessment of agents in a broad range of therapeutic categories including anti-cancer, anti-infective, AIDS, cardiovascular, reproductive, central nervous system, respiratory system and metabolic diseases. Our expert input has enabled numerous IND/CTA and NDA/NDS submissions.
Clients have benefited from our consultative input:
Well-planned nonclinical development programs and toxicology study protocols with time- and cost-savings to clients
Our critical, detailed review of data and reports ensures that findings are appropriately interpreted and reported
Potential issues in nonclinical studies and programs and their relevance and significance are promptly identified with appropriate perspective; additional steps to reconcile issues (e.g. histopathology peer review; additional investigative study) are recommended as appropriate
Clear and considered input related to nonclinical safety assessment facilitates decision making on issues such as first dose in humans, and Go/No Go decisions for development
Our professionals are experienced participants in multidisciplinary project teams
