Study Design

• Partner on design and/or review of clinical protocols to ensure fit-for-purpose endpoints, inclusion criteria, cohorts, duration, analysis strategy, schedule of events, etc.. Align the study with overall development goals taking into account all stakeholders.

Study Preparation

• Optimize the timeline to first-patient-in

• Advise on recruitment strategy (regions, treatment sites, follow up sites)

Study Submissions

• Prepare and submit clinical trial application to secure study approval

Study Conduct

• Optimize interaction between all stakeholders and ensure data collection and quality supporting your endpoints

Regulatory Maintenance

• Maintain regulatory dossier to ensure compliance