Site Under Construction - Coming Soon!

Specializing in IVD and CDx clinical research consulting

IVD Consulting Services:

Clinical operations project/daily management, clinical strategy, staff training/mentoring, Clinical QMS management and continuous improvements, global corporate initiative facilitation and implementation, FDA meeting preparation/strategy/execution, FDA submission preparation, and FDA Bioresearch Monitoring (BiMo) Inspection preparation/execution

About me:

Accomplished Senior Clinical Research Scientist with a FDA proven track record in developing Companion Diagnostic (CDx) and In Vitro Diagnostic (IVD) clinical strategy, leading clinical project management and operations, facilitating global quality changes, and securing FDA clearance/approvals. Extensive experience successfully managing all phases of clinical trials with pharmaceutical partners, from protocol development to site selection to final clinical study report, FDA submission, and inspections. Clinical Affairs leader adept at developing and implementing comprehensive clinical plans, ensuring compliance with regulatory standards. Passion for building clinical teams and processes with a continuous improvement mindset.

Core Competencies:

Clinical Research and Program Management | Companion Diagnostics | Regulatory Compliance  

Project Leadership | FDA Submission and BIMO Inspections | Cross-Functional Leadership

Clinical Operations Oversight | Budgeting and Resource Allocation | Stakeholder Communication | IVDR | Facilitation