Strategic Comparator Sourcing
Comparator sourcing is a bridge between two very different supply chains: Clinical and Commercial. Due to the growing cost of therapeutics, driven up by competitive pressures of biosimilar drugs, this bridge can be complex and heavily impacting the budget of your clinical studies. Access to industry expertise, market intelligence, sourcing networks and world leading services is important to optimize your trial.
A few general questions to start with:
- Sourcing – should I leverage centralized or local sourcing?
- How can l provide medicine to my patients faster?
- How can we import comparator services to my study in specific countries (i.e. China…)?
- How can we reduce waste and generate savings?
These and many more questions can be answered by our dedicated and global team of Comparator Sourcing Specialists that consult, assist and understand your sourcing needs. Along with our global footprint we guarantee product integrity and quality assurance by limiting supply chain steps.
Download our fact sheet to learn how our Comparator Center of Excellence Team can assist you with developing the most cost effective strategy for securing the medications locally, regionally, globally or a combination of all the above.
Interested in learning more about comparator sourcing?
Download our recent whitepaper that provides insights into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies. Thermo Fisher's Comparator team has the required expertise to leverage the Bolar exemption, providing clients early access to generic / biosimilar drugs.
Comparator sourcing: Leveraging the Bolar exemption to accelerate market access for generic and biosimilar products
Capabilities
- Direct sourcing: Accounts with innovators for direct sourcing to secure the best shelf life, proper batch sizes, and documentation for submission and logistics.
- Open market: A worldwide network for open market sourcing, including the EU and emerging regions, such as China and Latin America.
- Central sourcing: Leveraging the largest commercial markets to supply global clinical trials for complex supply chains.
- Local sourcing: Utilizing our expertise and global network of 20 owned GMP facilities to source locally in specific countries (with access to >40 countries).
- Blinding of comparators: Includes related analytical services (method development and validation, stability testing, release, and providing data for IMPD submission).
Services
- Sourcing strategy consultancy
- Single point of contact
- Market intelligence
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
Quality
Supplier Management
- Trade and tax compliance
- Up-to-date local import/export regulatory guidance ensuring GDP compliance
- Robust supplier qualification process and traceability guaranteed
- Anti counterfeit procedure
Product Handling
- Integrated services including clinical supply optimization, labeling, packaging, distribution
- Harmonized facilities, Quality Systems and organization ensuring GMP compliance
- Management of temperature control for transportation and storage and quality control on incoming goods
- Global recall procedure
Watch our webinar on 'Addressing challenges and key considerations for comparator sourcing in and to China'.
Comparator sourcing is crucial for ensuring the integrity of clinical trials, but it’s undeniably complex — especially when it takes place overseas. Watch our on-demand webinar to explore approaches to overcome the various challenges of comparator sourcing in and to China.
The webinar covers a variety of relevant topics, including how to:
- Build a bridge between obstacles and solutions for comparator sourcing
- Address concerns when establishing a commercial materials supply chain
- Reduce risk and costs with a strategic approach to sourcing comparators
- Make it all work, with a look at case studies and success story examples
