Camargo provides a full range of solutions to support Sponsors in building and delivering fully integrated nonclinical strategies to advance drug development programs to the clinic faster. Partner with Camargo for your preclinical program and reach critical early stage milestones on time and within budget.
Our solutions include:
- Nonclinical strategy and study design
- PK/PD expertise
- CRO vendor qualification, selection and ongoing management
- CRO auditing to ensure GLP compliance
- Study monitoring, including onsite observations and raw data review
- Study analysis and reporting, including NOAEL determination
- Project management
Camargo offers tailored development execution options to fit your needs
Many sponsors choose to run their studies in Canada, which offers world-class CROs, leading principal investigators and globally competitive pricing. Based in Canada, Camargo Research Group is our full-service solution to advance your program through nonclinical development and into early stage clinical. Close proximity to these resources ensures high-touch study execution services at a favorable cost.
For Sponsors with specialized needs or selection criteria, our experience working with CROs around the world allows Camargo to identify the most suitable partner for your program. Throughout the development process, our experts keep your program on track through a range of services including RFP management, auditing, vendor selection and management and study oversight. Contact us to learn more about our customized options.
Nonclinical solutions for 505(b)(2) development
If your product is a 505(b)(2), it’s important to note some distinctions in nonclinical development strategy between 505(b)(2) and traditional development programs.
- Public data may be used in lieu of novel trial data, making numerous nonclinical studies and other safety and efficacy tests potentially unnecessary to achieve 505(b)(2) approval.
- Because 505(b)(2) candidates often have known safety profiles and previous demonstrations of efficacy, risk is diminished, increasing investment appeal.
- 505(b)(2) often allows nonclinical and clinical studies to be completed in parallel, abridging the process of drug development even further.
Awareness of published literature, existing risk-benefit profiles and opportunities to run parallel studies are critical to building and executing a robust nonclinical program and services, to reduce short- and long-term costs.