How to reliably estimate remuneration for investigators and sites?

Estimating remuneration for investigators and sites is one of the key elements of planning a clinical trial budget. Mistakes at this stage may lead both to difficulties in site recruitment and to later operational problems or the need to renegotiate agreements. Therefore, the approach to valuation should be based on data, experience and market realities.

The starting point is a thorough understanding of the scope of responsibilities on the part of the site and investigator. Remuneration should reflect the actual workload related to the conduct of the study, including, among other things, patient qualification, visits, documentation, reporting of adverse events and cooperation with the monitor. It is crucial not to rely solely on general assumptions, but to analyse the Schedule of Activities (SoA) and assign specific tasks and working time to each visit and procedure.

In practice, remuneration is often calculated using a patient / visit / procedure model, which makes it possible to better align the budget with the actual activity of the site. It is also worth considering additional elements, such as start-up fees, administrative costs, archiving costs or remuneration for screening, including screen failures. Omitting these elements may lead to underestimating the budget and cause problems during the study conduct phase.

One of the most important aspects is referring to real market rates, which may vary significantly depending on the country, study type or therapeutic area. In this context, best practice is to involve a CRO in conducting feasibility — that is, verifying the possibility of conducting the study at sites, including the level of expected remuneration.

Thanks to direct contact with sites, it is possible to obtain current, real-life rates rather than relying solely on historical data or budget assumptions. Feasibility also makes it possible to identify differences between sites — not only in terms of recruitment potential, but also in terms of financial expectations. In practice, it may turn out that rates that are too low significantly reduce interest in the study or lower its priority at the site, which directly affects the pace of recruitment.

Local conditions should also be taken into account, such as the labour costs of medical staff, salary levels in a given country or market standards for a particular type of study. Attempting to apply uniform rates across different countries or sites often leads to errors and the need for later adjustments.

Budget flexibility is also an important element. Even the best-prepared estimate may require adjustment during negotiations with sites. Therefore, it is worth allowing for a certain margin and clearly defining the rules for possible changes, especially if the study is planned to start over a long time horizon.

In summary, a reliable estimate of remuneration for investigators and sites requires combining a detailed analysis of the study scope with up-to-date market data. Involving a CRO in the feasibility process can significantly improve the accuracy of the estimate and reduce the risk of problems during study conduct. A properly prepared budget not only facilitates cooperation with sites, but also has a real impact on the success of the entire study.