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Simplifying Your
Clinical Supply Chain
Expertise to ensure drug for patients on time, every time.
About Us
How much drug do we need? When can we have the drug ready? Why does it take so long?
How often do you hear those three questions in a given day? At Clinical Supply Advisors (CSA), we provide insight and tailored solutions to ensure clinical trials maintain an uninterrupted supply of drug for the entire duration.
Team CSA is a group of consultants holding over 10 years of clinical supply chain experience in the biotech industry. Navigating Good Manufacturing Practices (GMP) requirements for investigational product (IP) and building IXRS/IRT systems for complex drug designs can often seem difficult, but our team is here to offer insight on best practices that will simplify your clinical supply needs. Our team has experience managing the end-to-end supply chain for over 150 global clinical trials. We would welcome an opportunity to share our expertise to assist with addressing any questions or challenges within your clinical supply chain.
Team CSA is dedicated to ensuring
The highest quality of your clinical supplies are readily available for patients. Contact us today, to hear how Team CSA is able to support your clinical supplies!
Services
CMO / VENDOR MANAGEMENT
- Contract negotiations
- Person in Plant (PIP) oversight
- Lean process improvement
- Batch record review and approval
CLINICAL SUPPLIES MANAGEMENT
- Complex clinical trial designs (Phase I-IV, compassionate use, EAP)
- Label text generation, translation, and approval
- Coordination of global distribution and importation
- Quirky packaging and labeling solutions
- Gene therapy, cold chain and ultra low labeling and packaging solutions (2-8°C, -20°C, -40°C, -65°C)
- Sourcing of comparator drug and ancillary supplies
- Packaging configuration solutions
- Study site close out
- Inventory controls, study drug returns & destruction
- Coordinate expectations for QP management
FORECASTING
SOLUTIONS
- IRT build outs and vendor integrations
- Demand planning
- Patient planning
- Clinical supplies forecasting