Comparator Sourcing
The complexity of high cost biologics means comparator may be one of the highest line items in your clinical trial budget. Our Comparator Center of Excellence Team can consult and assist you in managing the full breadth of your comparator sourcing needs. Utilizing Fisher Clinical Services’ comparator sourcing services will provide you access to a global sourcing network and an overall de-risked supply chain. Currently 15 out of the top 20 worldwide pharmaceutical and biotechnology companies, as well many small pharmaceutical and biotech start-ups, actively utilize our comparator sourcing and strategy services.
Based in Switzerland, the Comparator Center of Excellence includes dedicated teams in the UK, USA and Asia. Our worldwide 30+ comparator employees leverage the local presence of Fisher Clinical Services in countries like Russia, China, Japan, India and Singapore. We support clinical trials with an integrated supply chain and dependable global sourcing strategies. Complete with full packaging and distribution services, documentation support and the highest product quality available, we strive to mitigate risk across the supply chain.
Drugs
- Any comparator drug or IMP
- Reference Medicinal Products
- Matching Placebo
- Rescue, background, co-medication and standard of care
- Everything from one sample to large quantities for multi-year phase III trials
Capabilities
- Central Sourcing: Working in partnership with innovators for direct sourcing to secure best shelf life, proper batch sizes, manufacturing of matching placebo and full comparator documentation (Certificate Of Analysis (CoA), Stability Data, Full Pedigree, etc.) for submission and logistics.
- Local Sourcing: Leveraging our expertise with our global network of 19 owned GMP facilities and 30 depots for sourcing in specific countries locally
- Open Market: Worldwide network for open market sourcing including emerging regions like China, Ukraine, Russia or Brazil. Access to pre-approved suppliers in all key markets including Asia and Latin America.
Services
- Sourcing strategy consulting and full-service procurement of drugs
- Reference Samples Sourcing Management for building up the reference library (quality work / physico-chemical characterization)
- Single point of contact for end-to-end comparator services
- Regulatory expertise and market intelligence
- Development of global and customized integrated strategies for sourcing, blinding, packaging, labeling, storage and distribution of the drug (or any combination).
Quality
Supplier Management
- Trade and tax compliance
- Up-to-date local import/export regulatory guidance ensuring GDP compliance
- Traceability guaranteed
- Robust supplier qualification process
- Anti counterfeit procedure
Product Handling
- Integrated services including clinical supply optimization, labeling, packaging, distribution
- Harmonized facilities, Quality Systems and organization ensuring GMP compliance
- Quality control on incoming goods
- Management of temperature control for transportation and storage
- Global recall procedure