Case Study

Agile Clinical Labeling: Overcoming Unexpected Delays

When a manufacturing defect reduced a clinical labeling window to just one-third of the usual duration, Myonex deployed an accelerated, compliant workflow that ensured on-time delivery, full quality oversight, and uninterrupted study continuity.

Client: European CRO with 30 years’ experience serving pharma companies of all sizes
Study: Phase 1, double-blind clinical trial targeting a rare hereditary neurodegenerative disease
Participants: 32 in the Single Ascending Dose, 24 in the Multiple Ascending Dose part
Solution: Accelerated blinded labeling of oral-solution bottles

Vial bottle getting packed into carton in a sterile environment

Challenge

In rare disease trials, every dose and every day count. When a pharmaceutical sponsor launched a study on a hereditary neurodegenerative disease, the timeline for blinded labeling was already tight.

The objective: deliver medication on time to an EU study site, in full GMP compliance.

During receipt inspection, Myonex personnel identified a manufacturing defect on the bottles. To ensure product integrity and patient safety, the batch was returned to the manufacturer for rework, leaving only one-third of the normal production time to complete clinical labeling.
The situation called for extraordinary coordination and precision to avoid a delay that could have severely impacted the study’s continuity.

The Myonex Solution

Myonex launched a controlled, collaborative acceleration plan to recover the lost time without compromising quality.
Teams from Production, Quality Control, and Logistics aligned closely to execute each phase with speed and reliability.

Key milestones:
• Day 1: Sponsor data and manufacturing instructions received; Master Batch Record (MBR) finalized, and approval workflow initiated.
• Day 2: Reworked oral-solution bottles received; goods inspection and identification testing completed the same day.
• By Day 4: Blinded labeling finalized after completion of the batch record, printing of blinded labels, and QC document review.
• By Day 6: Double review of the Executed Batch Record (Head of Production and Head of QC), followed by QP release.
• Day 10 & 11: Shipment of the medication to the study site and on-time delivery confirmed at the site.

Throughout the process, all operations remained under strict GMP oversight, demonstrating that speed never replaces quality.

Results

On-time delivery: Medication reached the study site as scheduled, enabling patient dosing to start on time.

Timeline reduced by 3x: All operations exceptionally completed in one-third of the standard duration.

Study continuity protected: Without Myonex’s rapid response, the study would have faced a significant delay or risked not proceeding at all.

Full compliance maintained: Every step followed approved SOPs, ensuring product quality and patient safety.

Exceptional teamwork: Seamless collaboration between Production, Quality, and Logistics teams enabled this achievement.

Doctor using a stethoscope on a child in a doctor's office

Conclusion

Even with the most robust risk management processes in place, sponsors can face unexpected challenges affecting subsequent clinical packaging and labeling steps. This project demonstrates how Myonex’s expert teams and structured processes deliver reliable, compliant, and patient-focused solutions, even under exceptional time constraints.

By combining a quality-first culture and a disciplined approach to risk management with demonstrated flexibility, Myonex ensures that every trial, from rare diseases to large global studies, benefit from the same commitment: Advancing Medicine Together, with precision, agility, and trust.

FAQ

Q1. How can Myonex accelerate clinical labeling while remaining fully GMP compliant?
A combination of flexible workflows, rapid approvals, and cross-team coordination that allows operations to accelerate when needed.

Q2. What happens if defects or discrepancies are found during goods inspection?
Myonex performs a documented assessment and escalates immediately. If product integrity is at risk, the batch is returned or quarantined, while recovery planning begins in parallel.