As a Clinical Outsourcing specialist my goal is to support Biotech and Biopharma clients with the right knowledge, decision making, and tools at the right time, and where needed, up-skill those organizations to be self-sufficient in the future.
With extensive experience gained from building and leading Clinical Outsourcing functions on a global basis for over 25 years, I provide consulting services on all aspects of Clinical Outsourcing including the following areas:
- CRO and ancillary provider selection
- Identifying the right outsourcing model
- Full-Service Outsourcing (FSO) vs Functional Service Provision (FSP) models
- RFI, RFP & RFQ design and execution
- Scorecard implementation
- Bid defense meeting facilitation
- Negotiation preparation, planning, and practice
- MSA negotiation
- Custom vs CRO bid grids
- Rate card benchmarking and negotiation
- Bonus, penalty, incentive, and earn back structures
- Budget models (unitized, fixed price/fixed scope, outcomes based)
- Payment schedules (unitized vs time & materials vs milestone based)
- Preferred provider / strategic partnership models
- Supplier governance and oversight models
- CROs managing third party providers
- Financial oversight and reporting
- Accruing labor costs, grants, and other passthroughs
- Foreign exchange and inflation
- Early termination of clinical programs
- Switching CROs
- Sourcing emerging technologies and solutions such as DCTs, DEI, and AI.
- Clinical site contracting and FMV assessment
- ICH GCP considerations for Clinical Outsourcing
- Vendor selection, qualification and oversight SOPs
- Procurement policies
- Design of Clinical Outsourcing organizations
- Sourcing & selection of Clinical Outsourcing staff
Company Details
- Founded
- -
- Address
- San Francisco, Us
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Keywords
- Clinical Outsourcing, Negotiation, CRO Governance, Strategic CRO Partnerships, Vendor Oversight, Clinical Trials, CRO Selection, MSAs, Outsourcing Models, RFIs/RFPs, Bid Defense meetings, Preferred Providers, Supplier Relationship Management, Financial Oversight, Clinical Site Contracting, FMV assessment, Bonus/Penalty, Payment Schedules, Vendor Selection, GCP, Clinical Procurement.
- HQ
- San Francisco
Clinical Outsourcing Consultant Questions
Clinical Outsourcing Consultant's LinkedIn profile is https://www.linkedin.com/company/clinicaloutsourcing
Clinical Outsourcing Consultant's industry is
Biotechnology Research
Clinical Outsourcing Consultant's top competitors are
San Antonio Research Group Llc,
Ihorizon.ie,
International Connect,
Ap Clinical Research Llc,
Community Research,
True North Contract Research,
Bht Consultant & Outsourcing,
Transfuture Advisors,
Clinical Development Outsourcing Strategies™ (Cdostrat),
Eminence Clinical Research, Inc.
Clinical Outsourcing Consultant's categories are Biotechnology Research
Clinical Outsourcing Consultant's founding year is 2024
