|
PharmaDirections offers expertly designed preclinical strategies to guide your drug development program from candidate selection to IND submission. By carefully charting a path that combines expert knowledge of pharmacology and toxicology regulatory requirements with the rigorous application of scientific and drug development know-how, we obtain the preclinical safety, efficacy and mode of action data needed to support your clinical trials. Our skilled and practiced scientists design and manage pharmacology, toxicology and ADME/PK studies to assess safety issues, define therapeutic dosing strategies, and support clinical efficacy. Through thorough analysis, creative problem solving, and the use of predictive tests, we navigate around many traditional preclinical pitfalls.
Key Benefits
Early identification of potential pharmacology and toxicology issues
•Program due diligence
•Strategic analysis of ‘critical path’ needs
•Design and execution of pivotal pre-IND pharmacology and pilot safety studies to reduce risk and increase comfort
•Availability of full range of IND Enabling pharmacology and toxicology studies services
Realistic time and cost projections for the preclinical studies needed to support your regulatory submission
•Expert guidance on study requirements
•Well defined roadmap of preclinical activities and estimated costs
•A ‘best of breed’ approach for selecting CRO's for study design and execution
Rapid problem identification and resolution
•Teams of disciplined pharmacology and toxicology scientists that can be assembled ‘on demand’ to troubleshoot and solve program issues
•
Immediate access to decades of practical drug development experience
•
Alternative strategies and risk assessment
Cost-effective translation of therapeutic opportunity to clinical reality
•
Expert project leadership by drug development veteran
•Rigorous project management and vendor management systems in place
•Seamless integration of pharmacology and toxicology studies with formulation and manufacturing
•Biomarker strategies for drug safety and efficacy
|
