Mitigating Risks Associated with a Multinational Phase 3 Vaccine Clinical Trial
A leading pharmaceutical company required support in identifying and planning for risks and scenarios that could arise during a multinational Phase 3 vaccine clinical trial.
Working across multiple functions from R&D through to legal and industrial operations, Shift Health identified and assessed the impact and likelihood of potential clinical outcomes, scenarios and risks, including those with scientific, clinical, operational or commercial ramifications. We then worked with the client to develop incisive contingency and communication plans in preparation of key trial milestones and anticipated outcomes so that everyone involved with the trial had a common ‘playbook’.
The clinical trial risk mitigation strategy and companion communications dossier supported the team in elucidating, evaluating and triaging trial risks and proactively developing mitigation strategies.