Case Study 1

Title: Phase I dose escalation

• Dose escalation study required extra cohort of 16 patients urgently to complete study.
• Monday: Teleconference with client.
• Tuesday: Prepare & approve documents for label text.
• Wednesday: Product labels, receive product from manufacturer.
• Thursday: Pack, release and distribute product.

Case Study 2

Title: Phase I toxic compound

• Required 20 patient kits packed and shipped at -20°C. Highly toxic compound.
• Product could only remain out of freezer for maximum of 5 minutes.
• IMP packed by team in walk-in freezer!
• Classified as dangerous goods. i.e. special pack and shipping conditions.
• Shipped successfully to site in Estonia on time.

Case Study 3

Title: Blinded complex study

• Nine drug materials, 7 table strengths + active and placebo auto-injectors.
• Innovative approach to labelling to ensure injector remained blinded after firing.
• Tables shipped refrigerated due to stability issues.
• Short timescales.
• Project completed successfully and on time.