Managing Investigator Site Budgets and Contracts

A managed service for clinical trial sponsors, improving cost efficiency while upholding quality and mitigating risk

The management of clinical trial site contracts and budgets requires a highly specialized skill set – from the contract structure, terms and conditions to meticulous negotiation – all against the backdrop of increasingly complex trials spanning multiple countries with varying regulations and protocols.

Smaller biopharma companies typically entrust this work to their contracted clinical research organization (CRO), with the investigator costs added to a pool of “pass through expenses” for the sponsor. This often results in underestimated investigator expenses and mid-study change orders. Moreover, CROs are not incentivized to pursue the best possible value on the sponsor’s behalf – concerned more about their budgeted hours than your outcome. In contrast, Danforth offers a managed service performed by clinical contracting specialists who act as an extension of your internal team – with the sole aim of protecting your best interests.

How We Help

  • We conduct an independent assessment and perform the budget modeling based on your protocol to provide an unbiased estimate of investigator fees – as opposed to relying on the CRO’s projected  expenses (which do not impact their bottom line). We leverage the industry standard Medidata Grants Manager and strictly adhere to all protocols in our assessments.
  • Our specialists apply deep expertise in the nuances of investigator site budgets and contracts, including the requirements of academic vs. non-academic institutions within and beyond the United States.
  • We are highly skilled negotiators with expertise in minimizing cost and identifying risks in site budgets and contracts. We manage the negotiation process in close coordination with your clinical, legal and finance representatives.
  • Following trial initiation, we can effectively manage changes to site agreements due to protocol amendments.

Our Clinical Business Operations (CBO) practice offers wide-ranging services to manage the outsourcing of clinical development and manufacturing, combining expertise in strategic contracting, sourcing, supply chain and finance management to maximize the value of relationships with CROs and other providers. Click here for more information.