Intelligent Contracting with Clinical Trial Sites

Transforming the Sponsor-Site Relationship

Contracting with clinical trial sites is a persistent bottleneck in drug development and clinical trials. Working with 2 large multinational pharmaceutical development companies we re-architected the process and infrastructure to optimise contracting with clinical trial sites. By using a design led approach to eliminate the high burden sponsors typically place on partnering investigational sites, we reduced the elapsed time to contract signature to one week from a previous median time of 75 days and significantly reduced the operational overhead associated with site contract management.

Finding Root Causes of Contract Delays

To achieve these gains we addressed the negotiation of the budget and the main agreement: the “body” (legals) and the “schedule” (commercials). Process analytics uncovered a huge amount of process variability at both sponsors. What leadership assumed to be a straightforward activity differed enormously depending on therapeutic area, phase, contract management modality (Full Service Provision, in-house resources, FSO or specialist teams). No mechanisms were in place to build and propagate institutional knowledge of site preferences, timelines or constraints, any negotiated language, and previously approved assessment pricing. As a result, this valuable intel was inconsistently retained and reused. Compounding this was the finding that 100% of contract managers and compliance leads had an incorrect understanding of the term “fair market value”, leading to unnecessary negotiations and stalled contracts.

Moving to the Top of the Site’s In-Tray

Having diagnosed the root causes of process variability, we worked with the clients to design a streamlined contract management approach. Using unique Site IDs, we built the optimised workflow into a digital tool to manage the process. This worked on a hybrid pull/push basis, moving the contract negotiation to the next stage automatically to bias the process towards completion and auto-populating site preferences on language and previously negotiated costs. This minimised the burden on sites and moved sponsor contracts to the top of the site contract manager’s in-tray because they were no longer facing a “from scratch” negotiation. The system retained data on clinical trial sites generated from the latest negotiations and made it available to all contract managers. One sponsor calculated a recurring productivity uplift of $4M annually in the US alone, based on FTE allocation to contract management. This is before accounting for the obvious recruitment benefit to studies of earlier site activation.