Strategic Clinical Development Advisory

Support across Phase I–III neuroscience programs.

• Development plan review and refinement
• Asset positioning strategy (CNS indications)
• Protocol optimisation (eligibility, feasibility, burden)
• Endpoint hierarchy and primary outcome selection
• Risk identification and mitigation planning
• Regulatory-supportive documentation review

Endpoint & COA/eCOA Strategy

Reducing variability. Strengthening signal detection.

• Selection of cognitive, behavioural and psychiatric scales
• COA/eCOA vendor evaluation and oversight
• Endpoint burden assessment
• Rater qualification and certification strategy
• Scale translation oversight
• Endpoint data trend analysis

Placebo Mitigation & Data Integrity

CNS trials are uniquely vulnerable to placebo response and rater variability.

• Placebo risk assessment
• Rater drift mitigation strategy
• Eligibility tightening frameworks
• Cognitive screening optimisation
• Data quality signal review

Governance & Sponsor–CRO Interface

Executive-level oversight for complex global programs.

• Governance meeting leadership support
• CRO performance evaluation
• Vendor integration oversight
• Cross-functional risk alignment
• Escalation pathway structuring

Training & Scientific Leadership

Building capability across investigator and site teams.

• Therapeutic area training (Alzheimer’s, Parkinson’s, Rare Epilepsy, Psychiatry, etc.)
• Endpoint administration training
• Investigator meeting presentations
• Bid defence and investor-facing scientific support

Custom Engagements

Each engagement is tailored — from a single protocol review to sustained strategic partnership across a development program lifecycle.