After required study documents are submitted to RMG CT Intake Team, your study will be assigned Clinical Trial Research Process Manager (CTRPM) to negotiate the budget for the study.
Your CTRMG team takes a collaborative approach to negotiating budgets. With this approach, a successful budget reduces any financial risk while also considering the sponsor’s budget parameters. Often budget approval requires support documentation for justification and/or escalation by CRO to sponsor or within the sponsor’s management.
We take time to ensure we agree on the best possible budget. It is equally important to build trust and a good reputation with sponsors.
For most industry-sponsored clinical studies, we negotiate a fixed-price per subject payment schedule with additional invoiced items.
Per subject payments are based on:
- best estimate of research personnel effort required
- standardized estimate of hospital costs
Negotiating the best possible CTA budget requires preparation. Information you provide to your CTRPM is critical to effectively and efficiently negotiate budget.
How to work with your CTRPM to support budget negotiation process
Reach out any time with questions to the CT RPM assigned to your study. Our goal is to negotiate the best possible budget and to maintain strong and lasting relationship with sponsors.
The following study information will help your CTRPM with establishing a timeframe for budget development:
• How many sites are currently activated?
• How many sites does the sponsor plan on activating?
• Does the sponsor expect their enrollment goal for this study will be met?
• How many patients are enrolled study-wide to date?
• What is the estimated date the last patient will be off the study?
• Is there competitive enrollment?
• Has a date for the Site Initiation Visit (SIV) been set?
• Does the sponsor require a finalized budget or executed contract prior to a Site Initiation Visit?