- Optimising kit design for clinical and IRT success
- Connecting bulk drug strategy to finished goods demand
- Building early alignment with clinical operations
- CRO market trends & the evolving outsourcing landscape
- Keys to effective CRO/CMO partnership & governance
- Strategic benefits of CRO collaboration
- Managing increasingly complex clinical trial designs
- Overcoming API availability constraints to enable agile scaling
- Navigating short product shelf-life to ensure reliable delivery to trial sites
- Selecting and tightly managing CDMO/CMO partners to reduce risk and delays
- Ensuring strong alignment with internal stakeholders to accelerate decisions and execution
- Simplifying consumables/component sourcing to reduce complexity and improve continuity
- Mitigating geopolitical and unexpected disruptions to protect supply chain sustainability
- Understanding and complying with regulation to limit delays
- Choosing a manufacturing and distribution model to suit trial supply
- Considering temperature monitoring and control options to reduce excursions and waste
- Reviewing challenges faced and lessons learnt