Expertise
Clinical Development and Operations
Robin works with clients to develop clinical strategy, research indications, write key documents, and manage operational components of clinical studies.
Contribute to and create documents for NDA, BLA/IND, response to FDA questions
Budget planning, forecasting, and management
Early strategic clinical planning
Reduce clinical development timelines
Ensure inter-departmental alignment of development plan with preferred label/marketing claims
Preemptive risk management planning
Site training designed for maximum impact to primary efficacy variable and low incidence of non-evaluable subjects
Clinical staff recruitment and development
Build long-term relationships with vendors and sites