In complex clinical trials, packaging and labelling are often treated as necessary operational steps — but secondary. In reality, they are critical control points. Errors in packaging are not remain isolated. They can delay site activation, trigger rework, create regulatory exposure, and ultimately disrupt patient continuity. This case study explores how BAP Pharma supported a sponsor in managing packaging risk within a multi-country Phase III trial — ensuring control, compliance and continuity under pressure.
The Sponsor was initially unsure of their enrolment and subsequently experienced rapid patient enrolment, which led to the need for increased quantities of materials and an unexpected change in their packaging schedule. Their on-going forecast identified a risk in both the timely fulfilment and expedited delivery to meet their revised patient recruitment timelines. If a traditional stock-building model of comparator sourcing and packaging and labelling had been used, the assurance of having the right products, in the right place, at the right time, would not have been possible. Additionally, if this traditional method had been used, it would have cost much more and resulted in a significant increase of wastage for any material the patient would have used. BAP Pharma adapted promptly by identifying alternative procurement options. This involved switching the source from the distributors to direct from the manufacturer. BAP Pharma successfully negotiated with the manufacturer to reduce the lead time and meet the strict batch expiry requirements, all with the required regulatory documentation, to ensure the packaging and labelling milestones were met. With this assured model of sourcing and our ability to supply through one integrated BAP Pharma team, we were able to deliver on our promises to the Sponsor to ensure an uninterrupted study. From a patient retention perspective, this meant that the Sponsor could continue with recruitment and complete the study as soon as feasibly possible.
Stock Expiry Management and Waste Reduction
BAP Pharma continuously monitored for further opportunities to minimize waste and optimize product availability by:
- Reducing stock in hand.
- Monitoring the market and negotiate with the manufacturer for superior shelf life/expiry and reduce lead times.
- Responding to changes in demand without creating risk of stock-outs.
- Not performing EU FMD decommissioning until necessary to ensure any excess stock remains as commercial product unless required by the Sponsor as research material.
- Reducing the number of originally forecasted packaging runs to complete the study.
- Preventing product excursions by packaging at refrigerated temperature and at low light within the BAP Pharma German facility.
The close collaboration between BAP Pharma’s Comparators and Packaging & Labelling teams and the Sponsor resulted in a reduction of the overall number of packaging runs and resulted in significant cost efficiencies and reduced risk of wastage. BAP Pharma Comparator Sourcing team performed a market assessment to understand the current and future supply chain of the requested product and to identify any risks. Known constraints, potential risks, recommended sourcing options, and risk mitigation tactics were continuously communicated and discussed with the Sponsor throughout the Phase III study. BAP Pharma managed supply plans and recommendations to account for all identified risks. A range of sourcing options, including direct to manufacturer and sourcing from one or more trusted and reputable distributors were evaluated, all to ensure there were robust options for sourcing throughout the life of the study. By integrating the BAP Pharma Packaging and Labelling team at this stage, the timelines from receipt to release were reduced, ensuring that the flexible sourcing and the on-demand packaging models were successfully delivered through an integrated BAP Pharma solution.
BAP Pharma’s Agile Approach
BAP Pharma’s “little and often” procurement strategy provides biotechnology companies with a flexible and lean approach to Comparator Sourcing, Secondary Packaging, and Labelling. By shifting to this model, sponsors can unlock key benefits:
- Reduced Financial Exposure – Instead of large bulk purchases, payments are spread over time, easing cash flow constraints—particularly useful for milestone-based trials.
- Accelerated Packaging & Labelling – Traditional timelines that span months can now be reduced to weeks, improving trial efficiency.
- Agile Scheduling & Forecasting – Trials often experience fluctuations in patient populations. This model adapts seamlessly, ensuring availability without unnecessary stockpiling.
- Optimized Risk Management – By procuring in smaller, more strategic quantities, sponsors can mitigate risks associated with expiration dates, supply disruptions, or regulatory changes.
- Sustainability in Practice – Minimizing wastage aligns with Environmental, Social, and Governance (ESG) priorities, promoting a more responsible clinical trial supply strategy.
