A study budget should explain the resources needed to deliver the work. When the budget follows only the visible visit schedule, relevant activities can be missed or their assumptions left unclear. PI PARTNER helps your team connect protocol requirements with an organised, traceable budget structure.
We work with principal investigators and independent research sites to identify activities, responsible roles, frequencies and cost drivers. The analysis makes the basis of the proposed budget explicit so that your team can review it and explain its position in discussions with a sponsor or CRO.
Start with the work the site must perform
The starting point is the agreed study information and your site's delivery model. A requirement may involve preparation, participant-facing work, documentation, coordination or follow-up. Several roles may contribute to the same activity, and its frequency may depend on assumptions that need to be stated.
We distinguish known requirements from estimates and questions. If a frequency, responsibility or resource requirement is unclear, it becomes an item to resolve. It is not silently converted into a firm cost or excluded simply because it is difficult to quantify.
The information we may need
After the scope and permitted exchange channel are agreed, relevant inputs may include the protocol and schedule of assessments, the proposed budget, site procedures affecting workload and the resource assumptions your team can provide. An amendment assignment may also require the preceding version and a record of the changes.
The first website enquiry should contain only a short professional description of your need. There is no upload facility. Do not include protocol extracts, patient information or confidential sponsor material. We agree the appropriate document handling arrangements before receiving those documents.
From protocol to activity to cost
Identify the activities
We organise the relevant requirements into a working activity map. Depending on the protocol and agreed scope, this can cover preparation, scheduled assessments, coordination, documentation and close-out. The map is tailored to the study; it is not a generic list assumed to apply everywhere.
Clarify roles and frequencies
We identify which site roles are involved and how often the activity is expected to occur. We record dependencies such as visit frequency, participant assumptions or events that may trigger additional work. Your team reviews the operational assumptions.
Structure the cost drivers
The activity map is connected to the agreed resource and cost inputs. We distinguish one-off work, recurring work and conditional activities where appropriate. Overhead and other indirect costs are identified explicitly when they fall within the agreed approach, reducing the risk of unexplained duplication.
Review the budget logic
We examine whether the proposed structure has omissions, overlapping items or assumptions that do not align. The review also identifies questions for the sponsor or CRO. Your team receives the basis of the calculation as well as the resulting budget structure.
Deliverables defined around your decision
The proposal sets out the deliverables for the assignment. They can include an activity and role map, a budget structure, documented assumptions and a list of questions or exclusions. A protocol amendment review can distinguish the effects of the change from the work already covered.
The handover explains how to read the analysis, where your team's confirmation is still needed and which inputs may require updating. This helps the person taking the budget into negotiation understand the reasoning behind it.
What remains with your team
You retain responsibility for clinical feasibility, staffing decisions, the accuracy of site-specific inputs and approval of any proposed budget. We do not make patient-care decisions, provide regulated legal advice or guarantee acceptance by a sponsor or CRO.
We do not claim access to a proprietary fair market value database. Where an assignment needs a comparison or external reference, its source, permission to use it and limitations must be considered explicitly. A reference is not a guarantee that a proposed amount will be accepted.
Common questions
Can you work on an existing proposed budget?
Yes. The scope can focus on comparing the proposed structure with the work required, identifying missing assumptions and preparing questions. The proposal will specify the depth of review and the inputs needed.
Can the work cover an amendment?
Yes. An agreed amendment review can examine changes in activities, frequencies and responsibilities and their effect on the budget. The available versions and change information determine what can be assessed.
Will every possible cost be included?
The analysis is bounded by the agreed scope and available information. We record assumptions, exclusions and unresolved questions so that you can assess those limits before relying on the output.
Request a tailored proposal
Tell us whether you are evaluating a new study, reviewing a proposed budget or assessing an amendment. We will discuss the support and deliverables appropriate to that decision.