All pharmaceutical companies today are racing to bring new treatments to market as quickly as possible. They often conduct multiple clinical trials simultaneously for different drugs (combination trials) and also attempt to determine various uses of the same drug (drug repurposing). This can lead to faster approval of the drug and have a broader impact, as drugs for several ailments are discovered simultaneously.
But there’s a hidden challenge in comparator sourcing for the combination clinical trials or drug repurposing trials.
Why Comparator Sourcing Becomes a Challenge?
Comparator sourcing becomes challenging for two types of clinical trials: combination trials and drug repurposing. Let’s understand why it is challenging:
1. Combination Clinical Trials:
Combination Clinical Trials determine the safety and efficacy of two or more drugs together, like using a Semaglutide (Ozempic) in combination with Metformin for diabetes or combining Keytruda with Carboplatin and Paclitaxel for metastatic squamous NSCLC.
The challenge here lies in consistently sourcing the combination drugs in large quantities, with uniformity in batches, labeling, and expiry dates, all while meeting regulatory standards. A delay in even one drug can put the entire trial at stake.
2. Drug Repurposing Trials:
In drug repurposing trials, existing drugs are tested for new uses. Some of the examples of such drugs are ildenafil (Viagra), Semaglutide (Wegovy), Minoxidil, and Aspirin.
Again, comparator sourcing for drug repurposing trials poses a challenge. The efficiency of the repurposed drug is required to be compared with a standard-of-care comparator. These comparators are not always easily available, especially in a compliant, and trial-ready state. An incorrect sourcing strategy can lead to delays, budget overruns, or even regulatory issues.
No matter the trial type, pharmaceutical companies frequently face issues in comparator sourcing like:
- Lack of traceability and regulatory documentation
- Issues with expiry dates or batch inconsistencies
- Delays in availability or unexpected shortages
- Costly surplus or overstocking
- Packaging compliance issues
These challenges can derail trial timelines, increase costs, and reduce the quality of the data collected.
Spring Bio Solution–Your Saviour in Tackling the Comparator Sourcing Challenges
Spring Bio Solution is a strategic sourcing partner, specializing in end-to-end comparator and reference drug sourcing for clinical trials.
Lets check what exceptional services we provide in comparator sourcing:
- Global vendor network: Providing access to validated suppliers across regions
- Regulatory expertise:Delivering full documentation, traceability, and compliance with FDA/EMA standards
- Agile logistics – Ensuring delivery that’s on time, cost-effective, and risk-proof
Whether you’re sourcing drugs for combination trials or repurposing studies, our support ensures your trial doesn’t get delayed due to supply chain gaps.
If you’re developing innovative drugs and want a smarter, more reliable approach to comparator sourcing, let’s talk.
FAQs:
Why is comparator sourcing critical for combination and drug repurposing clinical trials?
In combination and drug repurposing trials, comparator availability, consistency, and regulatory compliance are critical for comparator sourcing.
Why is comparator sourcing more complex in combination or drug repurposing trials?
Combination and drug repurposing trials require consistent and compliant supplies of each comparator drug. Comparator sourcing for these trials require drugs from same batch, continious supply or documentation issues.
What are the most common challenges faced during comparator sourcing?
The most common challenges include inconsistent batch availability, expiry date misalignment, lack of regulatory documentation, supply shortages or overstocking and packaging compliance issues.
Who requires strategic comparator sourcing services?
Strategic comparator services are ideal for pharmaceutical companies conducting combination drug trials,drug repurposing studies, global or multi-site clinical trials.
