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Develop better Phase 2 and 3 clinical trial protocols using Estimand thinking and industry-standard Transcelerate and ICH M11 protocol templates

Representing sponsors at FDA and other key meetings

Developing Statistical Analysis Plans incorporating Estimands (ICH E9 R1) and Transcelerate template

Provide sponsor oversight for outsourced data management, biostatistics, and programming services

Develop manuscripts for peer-reviewed journals and presentations for industry conferences

Recent experience in the design and analysis of studies in ALS, Huntington’s disease, and rare diseases

Expertise in stroke, spinal cord injury, Parkinson’s disease, hypertension, etc.

CRO selection, project management, and budget oversight

Over 40 years of experience in drug development