Site Contracts

V2 is known industry-wide for accelerating site contracts without compromising quality or compliance. Our team brings years of experience negotiating agreements across academic medical centers, community sites, and global regions. 

We understand internal review cycles, indemnification expectations, data clauses, publication terms, and privacy requirements across territories.

Services include:

• Redline support and counterproposal development
• Indemnification, insurance, privacy, IP, and data-use clause negotiation 
• Harmonized contracting strategies across regions 
• Academic medical center negotiation management 
• Contract templates, playbooks, and negotiation frameworks 
• Coordination between legal, clinical operations, and finance 
• Cycle-time tracking and bottleneck analytics

Our lens is practical: reduce touchpoints, remove administrative burden, and move sites to activation with fewer surprises.

V2 provides end-to-end outsourcing strategy for small to mid-size biopharma, supporting vendor selection, negotiation, governance, and performance management. Our team understands the realities of early-stage biotechs: constrained budgets, aggressive timelines, and the need for partners who deliver without overengineering.

Services include:

• CRO, CDMO, central lab, and specialty vendor selection 
• RFP development, scoring, and comparative analysis 
• MSA and SOW negotiation (scope, assumptions, pass-throughs, governance) 
• Risk allocation and performance oversight frameworks 
• Change order review, reconciliation, and challenge strategy 
• FSP model design and transition planning 
• Budget alignment with operational planning 

The goal is simple: the right vendor, the right scope, at the right cost, with transparent accountability.

V2 specializes in FMV-aligned site budgets that reflect therapeutic complexity, procedure intensity, burden-of-care, and regional cost drivers. Our approach blends benchmark data, comparable trial budgets, and sponsor-specific assumptions to develop budgets that pass site scrutiny and avoid protracted negotiations.

Services include:

• FMV alignment and justification  
• Baseline and country-specific budget development 
• Cost-driver analysis and risk scoring 
• Tiered budget strategies for global trials 
• Budget-to-contract harmonization 
• Negotiation support for high-cost procedures or special populations 
• Oversight of resubmissions and multi-round negotiation.

We emphasize clarity and defensibility to reduce friction at sites and accelerate start-up.