Salim Shaikh, Founder and CEO of Spring Bio Solution, has authored a new article, “The Intelligence Gap in Comparator Sourcing: Why Clinical Trial Teams Are Still Flying Blind”. This article examines one of the most costly yet overlooked problems in clinical research: the disconnect between comparator sourcing intelligence and trial design.
Sponsors invest millions in protocol design, regulatory planning, and patient recruitment, yet comparator-related challenges routinely surface six to nine months into execution. This triggers avoidable delays, protocol amendments, and study redesigns. As Salim says, the root cause is structural, not operational.
The data that could flag these risks early, like batch availability, expiry windows, manufacturer lead times, and regional pricing and regulatory variation, already exists within the supply chain. It simply never reaches the teams designing the trial at the point where it can still shape decisions.
The article puts real numbers to the problem: protocol amendments now cost between $141,000 and $535,000 each, a single day of delay carries a revenue impact of roughly $500,000, and 30 to 55% of procured comparator stock goes unused by a study’s end. It also explores where the gap is widest, particularly in biologics and specialty drugs, and how the same blind spot repeats upstream in biosimilar portfolio planning, with 118 biologics set to lose exclusivity by 2034.
Salim’s conclusion is refreshingly practical: the opportunity is not for better data, but for better timing. By bringing sourcing intelligence to the design table while the protocol is still taking shape, teams can turn a costly month-seven amendment into a line in a plan that was correct from the outset.
Read the full article to see why teams are still “flying blind” and what to do about it.
International Clinical Trials, Clinical Trials Supply and Logistics Supplement, August 2026, pages 52–54. © Samedan Ltd.
FAQs
What is a comparator drug in a clinical trial?
An existing, approved treatment used as the benchmark to measure a new investigational drug against. About two-thirds of trials use one.
Why are comparator drugs so hard to source?
Limited batches, short shelf lives, country-specific import rules, and capped manufacturer volumes are hardest of all for cold-chain biologics.
How much do sourcing delays cost a trial?
Each protocol amendment runs $141K–$535K, a day of delay ~$500K, and 30–55% of procured stock often goes unused.
How can sponsors avoid comparator sourcing problems?
Bring sourcing intelligence in early; a short “sourcing brief” during protocol design catches supply issues before decisions are locked.
