Why Clinical Supply Needs Creativity

By Susana Nino-Kopcow, SNK Consulting

Procedures ensure compliance. Creativity keeps us moving.

The goal of clinical supply is simple: deliver the right product to the right patient at the right time, in the right condition.

Achieving that goal is not simple. It requires planning, discipline and the ability to adapt when enrollment, logistics, regulations or product availability change.

Clinical supply is often seen as procedural. It depends on SOPs, GMP, regulations, specifications and accountability. These controls protect patients, preserve product integrity and support reliable clinical trial data.

But procedures alone are not enough to get every patient the right dose at the right time.

The best clinical supply professionals I have worked with are creative. Not because they work around the rules, but because they find solutions within them to meet study needs and timelines.

When supply teams are creative, the impact is real: fewer missed doses, less wasted product, fewer protocol deviations and sites that trust the supply chain enough to keep enrolling. When they are not, the cost shows up as delays and write-offs. An enrolled patient who misses a dose may no longer count toward the analysis, and enough of those missed doses can put the study's results at risk. Most importantly, it shows up as patients who wait.

No Two Studies Are Alike

Every trial brings a different mix of protocols, countries, sites, enrollment patterns and patient needs. A supply strategy that worked in one study may not work in the next.

Once the study starts, things change: a comparator shortage, a customs hold, a patient who moves mid-treatment. There is no SOP for these moments, only a patient waiting for their dose.

Each trial needs its own strategy, built on flexibility and visibility.

One Product, Two Strategies

Consider a Phase 2 oncology study run at 40 sites in the U.S. and Western Europe. Enrollment was steady and predictable, so the team packaged the product in two large campaigns with country-specific labels and resupplied sites from two regional depots through an IRT system. It worked well, with minimal waste and no missed doses.

Then the same compound moved into Phase 3: 150 sites across 18 countries, including several in Latin America and Asia-Pacific. Enrollment was harder to forecast, import permits took months in some countries, and the product had only 12 months of shelf life at release. Copying the Phase 2 approach would have meant dozens of single-country label versions, inventory stranded in the wrong places and product expiring on the shelf.

So, the team changed the strategy. They moved to a multi-country booklet label covering most markets. They held part of the supply as unlabeled bulk at the packager and labeled it in smaller, just-in-time runs as enrollment became clearer. They set up local depots in countries with long import timelines and set IRT resupply triggers by country rather than globally. They also planned with Quality Assurance for expiry extensions and relabeling as new stability data became available.

Same product. Same SOPs. A very different strategy. The rules did not change; how the team used them did.

Creativity Within the Rules

Creativity in clinical supply does not mean taking shortcuts with quality or regulatory requirements. It means recognizing the options that exist within them.

That may include:

• Using multi-country or booklet labels to move inventory where it is needed.
• Extending expiry and relabeling product when supported by stability data, Quality Assurance, and local requirements.
• Transferring stock between sites or returning it to a depot for controlled assessment and re-release.
• Keeping product in bulk or unlabeled longer to preserve flexibility as plans evolve.
• Asking "What else could work?" rather than relying on past practices.

Every option still needs appropriate documentation, Quality Assurance oversight and regulatory assessment. That is what makes it both creative and compliant.

Why Cross-Functional Collaboration Matters

The best solutions rarely come from one person. They come from bringing Clinical Operations, Quality Assurance, Regulatory, CMC, packaging vendors, depots, logistics providers and sites into the conversation early.

In the Phase 3 example above, the booklet label worked because Regulatory confirmed country requirements early, and just-in-time labeling worked because the packaging vendor reserved capacity in advance. Neither would have been possible if those partners had been brought in after the problem appeared.

Quality Assurance and Regulatory are not barriers. They help identify compliant flexibility and the evidence needed to use it. Leaders should also create space for teams to raise, assess and test new ideas before issues become crises.

In clinical supply, creativity is not a nice-to-have. It is part of the job.

About The Author:

Susana Nino-Kopcow is Founder and Principal of SNK Consulting, where she advises biotech companies on clinical supply strategy, external manufacturing and CMO/CDMO management across biologics, small molecules, oligonucleotides, and cell and gene therapies. She brings more than 20 years of experience in end-to-end clinical and commercial supply chain. Most recently, as Executive Director of Global Supply Chain at Karyopharm Therapeutics, she led supply operations across more than 40 countries and guided the company through the commercial launch. She previously held supply chain and sourcing leadership roles at Nitto Avecia and Shire, including supply for orphan drug programs. Susana is based in Boston and is bilingual in English and Spanish.