How I Can Help
Bringing 25+ years of hands-on clinical development and regulatory expertise to biopharmaceutical companies worldwide
Clinical Services
Building compliant, successful programs
From hands-on operational support to strategic protocol development and CRO management
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.
Clinical Operations
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.
Independent, objective guidance in selecting the right CRO partner for your program. Drawing on my experience founding and managing a CRO, compounded with years of consulting with Sponsors on vendor selection. 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.
CRO Selection
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
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 bring process discipline and accountability to your CRO relationships, ensuring you get the quality and responsiveness your program deserves.
Clinical Management
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
Ensuring CRO deliverables align with Sponsor objectives
Quality Management Systems
Building quality into your operations from the ground up. I help organizations of all sizes establish quality systems, even those who 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
SOP GAP analysis
Trial Master File (TMF) auditing
REGULATORY SERVICES
Strategic FDA engagement & advocacy
Expert representation across Pre-IND meetings, End-of-Phase II consultations, and IDE discussions
Pre-IND Strategy & Representation
Early FDA engagement can save significant time and resources. I have served as the clinical representative for Sponsor teams during Pre-IND preparation and Meetings, and I strongly advise clients to engage early.
Pre-IND Strategy & Representation
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
When Sponsors come prepared with relevant questions, the FDA is remarkably supportive. My experience facilitating productive Pre-IND discussions helps clients maximize the value of these critical early interactions.
FDA Advocacy & Representation
With participation in more than 30 CBER meetings over 25 years, I bring deep experience in clinical strategy presentation and FDA advocacy. My involvement spans:
Pre-IND Meetings/WRO preparation
End-of-Phase II Meetings
IDE (Investigational Device Exemption) Meetings
Interactions across multiple FDA centers
I've successfully managed numerous IND and BLA submissions, preparing clinical sections for regulatory submissions and authoring protocols across diverse therapeutic areas.
My approach combines technical expertise with strategic advocacy, presenting your development program in the strongest possible light while maintaining scientific credibility and transparency.
WORKING TOGETHER
Flexible engagement options
I understand that every client has different needs and financial constraints. I offer flexible consulting arrangements including:
If your needs extend beyond my core expertise, I can connect you with trusted professionals in my network to ensure you have the right support for every aspect of your program.