We often hear this common concern from clinical trial managers: “We need a comparator drug from a single batch, and we can’t find it anywhere.” Recently, we received a query from our client for a prostate cancer drug approved by the US FDA in 2023. Our client urgently required 300 packs from a single batch, sourced specifically from the European market. Despite many attempts, the comparator sourcing from a single batch was not feasible for them. Lacking accurate visibility into the real-time market situation made the situation worse for them.
Why Single-Batch Comparator Sourcing Is Crucial
Sourcing comparator drugs from a single batch helps clinical researchers in many ways. These include:
- Maintaining data consistency by eliminating batch-to-batch variability
- Controlling the cost of the comparators by avoiding mid-trial price hikes
- Providing sourcing security against future comparator stockouts
- Giving control to the clinical sponsor of the overall program development timelines and cost
- Helps maintain an optimum inventory of the clinical trial supplies
The Real Challenge: Lack of Clear Market Intelligence
Fulfilling single-batch sourcing needs is not as simple as it seems. It is incomplete market intelligence and unreliable supplier information that make it difficult to procure comparable drugs from the same batch.
Sourcing comparators from the same batch rarely stems from a supply shortage. This difficulty arises because sponsors don’t have:
- Transparent visibility into real-time stock levels
- Access to verified supplier networks
- A clear understanding of the risks associated with each sourcing route
Introducing 360Scope™: Comparator Sourcing Reimagined
Spring Bio Solution addresses these challenges through a 360-degree approach combining domain expertise and market intelligence. Here’s how we helped solve the prostate cancer comparator drug issue:
- Giving a situational analysis to the clinical sponsor
- Aligning sponsors’ requirements with market realities
- Helping sponsors address single batch procurement challenges
- Supporting in procuring comparator drugs without any hassles
Make Single-Batch Sourcing Hassle-Free
If your team is struggling with comparator sourcing, ask yourself:
- Do we have real-time visibility into global supply?
- Are we working with trusted sourcing partners?
- Do we understand regulatory hurdles across regions?
- Can we reliably secure single-batch comparator stock?
If the answer is “no” to any of the above questions, it’s time to simplify your sourcing process with expert help.
Let’s Solve It Together
At Spring Bio Solution, we specialize in strategic comparator sourcing that supports clinical trial success. If you’re facing a challenge, we’re here to help. Contact Spring Bio Solution experts and transform the complexity of comparator sourcing into clinical trial confidence.
FAQs:
Is sourcing a comparator drug from the same batch important?
Using a single batch in comparator sourcing maintains product consistency and eliminates a variable that could possibly contribute variability to the study results. Thus, inconsistencies in the clinical data are avoided to maintain data integrity.
How many months prior should we plan the comparator drug sourcing strategy?
Ideally, comparator sourcing should be integrated into trial planning at least 5 to 9 months before the execution of clinical trials.
What are the risks when the comparator is sourced from multiple batches?
The risks include potential data variability affecting trial validity and regulatory questions about clinical trial study design and its results.
How do global market differences impact comparator drug availability?
Innovator products often have different launch dates, batch sizes, and distribution patterns across global markets. Sometimes, a product that’s scarce in one region may be more readily available in another, making global market knowledge essential for successful comparator sourcing.
What documentation should we expect from comparator sourcing suppliers?
At minimum, you should receive batch information, expiration dates, certificates of analysis, temperature monitoring data, and chain of custody documentation. For certain trials, additional documentation regarding manufacturing conditions may also be required as part of complete comparator drug sourcing.