The path to the clinic starts here.
Comprehensive preclinical research is the most critical element of an IND, there are no shortcuts to be taken.
We support our clients with the resources and expertise they need to design and oversee toxicology and safety pharmacology studies (in vitro and in vivo). The goal of these essential studies is to predict the safety of your drug, thus paving the way for safe dosing in humans.
We provide comprehensive preclinical support.
During the preclinical research phase, our team will help you focus on identifying both the limits of safe dosing and the specific adverse event liabilities, thus minimizing risks to clinical subjects as well as risks to your program. Moreover, we provide Single Study Support and can quickly determine if your candidate requires a quick proof-of-concept pharmacology study or a bridging toxicology study.
Regardless of what your clinical candidate needs, we will assemble the senior preclinical experts and project management support to:
- Develop a global preclinical plan
- Implement a strategy to support the clinical development plan
- Design the most effective studies
- Find and audit vendors needed to conduct the studies
- Develop all necessary protocols
- Monitor studies and interpret results
- Review reports and support their preparation
- Summarize results and incorporate them into your IND or other submission
- We will help you design, outsource, and oversee your study
- We bring the expertise, experience and team your project demands
- We can execute complete IND enabling preclinical programs
- We act as your champion before FDA and other regulatory bodies