Clinical trial optimization at protocol design

Topics

Cross-department collaboration (CTS, CMC, ClinOps)

Pharma/Biotech

Simulations & risk-based optimization

Date

August 7, 2025

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N-SIDE clinical supply experts collaborated with the Clinical Supply team at Merck to optimize the trial design stage in an important oncological trial program. In this Case Study, you’ll learn how the project exceeded targets for waste reduction and cost savings, all while ensuring patients were kept at the heart of trial design.

€18m

Achieved €18 million in total sourcing cost savings

10 months

Accelerated recruitment by 10 months

40%

Decreased drug waste by over 40%

Enabling fact-based protocol design

Optimizing early, during clinical trial design, presents an important opportunity for companies to reduce drug waste and cost, as well as accelerate timelines. At N-SIDE, we take into account every aspect of a clinical trial design to provide our customers with the data to make informed decisions.

When developing the clinical protocols for three oncological trials within a strategic clinical program, Merck contacted N-SIDE to assist with their trial optimization.

With the identified goals of reducing both waste and budget for these complex trials, the N-SIDE team collaborated with the Clinical Supply team at Merck to compare multiple scenarios using innovative approaches. N-SIDE’s Supply App was used to optimize the trial protocols and provide factual support for decision-making.

With the results from N-SIDE, the Clinical Supply team at Merck was able to make fact-based decisions that enabled the project to exceed targets for waste reduction and cost savings, all while ensuring patients were kept at the heart of the trial designs.

Areas of improvement across trial design

Kit design

The optimal kit design for a trial cannot be identified in isolation, and must take into account overall trial design, constraints and risk. N-SIDE clinical supply experts used the Supply App to assess the kit design possibilities for the three trials, resulting in a 24% reduction in material cost and 41% reduction in waste.

Visit intervals

Having the facts about the impact of adjustments to the visit window allowed for clear assessment and early collaboration between the Clinical Trial Supply and Clinical Teams at Merck. This led to a €1.8m cost savings without impacting the patient centricity of the trial.

IRT optimization and trial design

This particular clinical trial had an open-label comparator treatment arm and very high comparator sourcing costs. N-SIDE experts identified the opportunity to optimize the trial design and IRT settings together in order to avoid static buffers for the comparator, which led to an impressive €18m in cost savings.

Time-to-market efficiencies

N-SIDE experts tested the impact of accelerating the trial recruitment period. With these results, the Merck Clinical Trial Supply team was able to avoid all supply chain bottlenecks and achieved a 10 month acceleration in recruitment, while only needing to increase production by 12%.