How I Can Help
Comprehensive clinical development and regulatory support tailored to your program's needs
CLINICAL SERVICES
Building compliant, successful programs
From hands-on operational support to strategic protocol development and CRO management
Clinical Operations
Hands-on operational support that keeps your studies compliant and on track. My decades of experience mean I've encountered and solved countless operational challenges. Whether you need troubleshooting support or creative solutions to complex situations, I bring practical expertise that keeps studies moving forward and reducing deviations.
CREATION OF ESSENTIAL STUDY DOCUMENTS
Investigational Product Manuals & Logs
Source Record Worksheets
Participant Diaries & Study Manuals
Custom operational tools tailored to study needs
Clinical Development
Strategic protocol development backed by a proven track record of successful product registrations. My approach integrates:
The result? Protocols that are scientifically sound, operationally feasible, and designed for regulatory success.
CRO/Vendor Selection
Independent, objective guidance in selecting the right CRO partner for your program. Drawing on my experience founding and managing a CRO, combined with years of consulting with Sponsors on vendor selection, I've developed proven tools and methodologies for effective partner evaluation. My dual perspective as both a former CRO owner and a Sponsor consultant ensures you get unbiased recommendations that truly serve your program's needs.
DEVELOPMENT OF PROVEN TOOLS & METHODOLOGIES
Effective shortlisting criteria & processes
Comprehensive SOP & quality systems review
Bid comparison & resource allocation analysis
RFI and RFP development & management
Weighted objective decision-making scoring systems
Clinical Management
When your team needs additional resources or you're in early stages without a full clinical operations department, I serve as your Clinical Arm. I can perform all study start-up activities before engaging a CRO. Once ready, you can support and manage your CRO relationships, ensuring you get the quality deliverables and responsiveness your program deserves.
COMPLETE SPONSOR OVERSIGHT & MANAGEMENT
Study initiation & startup coordination
Day-to-day CRO oversight & performance management
Timeline development & tracking
Clinical document preparation & review
Budget management & oversight
Budget management & oversight
Quality Management Systems
Building quality into your operations from the ground up. I help organizations of all sizes establish quality systems, even those that outsource most clinical work. Quality doesn't have to be burdensome. I create practical, scalable systems that support compliance without slowing you down.
SOP authoring & development
Forms, templates, & log creation
Quality system implementation tailored to company size & needs
Trial Master File (TMF) auditing
SOP GAP analysis
REGULATORY SERVICES
Strategic FDA engagement & advocacy
Expert representation across Pre-IND meetings, End-of-Phase II consultations, and IDE discussions
Pre-IND/IDE Strategy & Representation
Early FDA engagement can save significant time and resources. I have served as the clinical representative for Sponsor teams during Pre-IND/IDE preparations, Meetings, and WRO — I strongly advise clients to engage early.
When Sponsors come prepared with relevant questions, the FDA is remarkably supportive. My experience facilitating productive Pre-IND/IDE discussions helps clients maximize the value of these critical early interactions.
Clarify FDA expectations before major investment
Identify potential issues when pivots are still possible
Build a constructive relationship with your review team
Achieve cost savings by getting it right the first time
WORKING TOGETHER
Flexible engagement options
I understand that every client has different needs and financial constraints. I offer flexible consulting arrangements including: