Clinical Research Administration

Budget & MCA Outsourcing Solution

Clinical trial budgets and Medicare Coverage Analyses (MCAs) are among the most technically demanding, high-stakes activities in trial activation. Yet, they are routinely handled by under-resourced staff without specialized training or dedicated time to do them well.

Cut budget finalization cycle times by 50-70%

Vitalief's Budget & MCA Outsourcing solution delivers fully managed, expert-led budget development and coverage analysis for sites, academic medical centers, and health systems. Our team operates as a seamless extension of yours, working within your existing systems, SOPs, and governance structures to produce fast, accurate, protocol-aligned budgets and coverage determinations that protect financial integrity and move studies forward.

For sites and institutions, our solution eliminates missed billables, FMV misalignment, and compliance risk while reducing the burden on internal teams.

For sponsors and CROs, it accelerates activation timelines and reduces negotiation cycles with fewer amendments and stronger documentation from the start.

Our Four-Phase Delivery Model

Vitalief's approach is designed to integrate smoothly into your environment and deliver measurable improvement at every stage.

Discovery & Alignment - We begin by understanding your existing processes, systems, and governance requirements to ensure a seamless fit. No ramp-up delays, no workflow disruption, just a configured engagement that works from day one.

Budget & MCA Development - Our specialists develop protocol-aligned budgets and clear, defensible Medicare Coverage Analyses with speed and precision. What traditionally takes days or weeks is completed in hours, with full documentation and rationale to support compliance and negotiation.

Negotiate & Manage - We provide expert support throughout sponsor negotiations, closing gaps, reducing revision cycles, and keeping budgets moving forward with strong FMV justification at every stage.

Govern, Measure, Perform & Improve - Ongoing visibility through clear KPIs, governance structures, and continuous improvement processes ensure you maintain control while we drive operational performance.

Benefits

Vitalief's Budget & MCA Outsourcing solution is built for speed, accuracy, and sustainability — so your team can stay focused on activating and executing studies while we handle the financial and compliance complexity.

Faster study activation — budgets developed in hours, not days or weeks
Clear, defensible MCAs — protocol-aligned coverage analyses that hold up to scrutiny
Stronger negotiation outcomes — robust FMV justification and expert sponsor negotiation support
Reduced compliance risk — fewer amendments, fewer billing errors, and stronger documentation
Scalable capacity — expert support that grows with your portfolio, without adding headcount

Why Choose Vitalief

Sites, academic medical centers, and health systems choose Vitalief's Budget & MCA Outsourcing services because we combine deep clinical research and billing expertise with technology-enabled delivery, giving clients faster, more accurate results than in-house or generalist teams can achieve alone.

We bring specialized knowledge, not just staffing. Our professionals understand both the regulatory environment and the operational realities of busy research offices. Whether you need fully remote, on-site, or hybrid support, Vitalief offers flexible delivery models with transparent governance, clear performance metrics, and ongoing visibility into your financial operations.

We operate as an extension of your team so you get expert capacity without the overhead of building it internally.