Initiating a clinical trial Sponsors are focused on quick and smooth start-up, fast patient recruitment and successful trial conduct and completion. For this purpose, the Sponsors are trying to select the sites that are providing best-in-class healthcare services in the given region for the given nosology and have a big number of potential trial patients.

The range of the selected sites is sometimes quite predictable, and we – contract negotiators – often can guess which sites will be selected just knowing the protocol title and list of countries, as well as we can do some guess work on how long the negotiation will take with this or that site, especially if it is some huge academic institution with a lot of clinics and departments involved.

Practice shows the bigger site is – the more complicated and lengthy negotiation can be expected, and the chances for contract execution to be the bottle neck in the process of trial start-up are relatively high. From Sponsor to Sponsor, study to study, we sometimes deal with several same sites, yet having to negotiate the clinical trial agreements from the very beginning. Surely, we can ‘clone’ contracts, but this option doesn’t work in majority of cases since it can be different Sponsors (and Sponsor-specific templates), different departments can be involved, etc.

Trying to reduce CTA negotiation timeline impact on trial start-up, many Sponsors came up to a clever decision (and we also encourage our clients to do the same): execution of the Master Service Agreement (MSA) with the frequently selected sites.

It is absolutely clear the MSA cannot fully cover each trial – at least budgets are study-specific, and there is still a lot to negotiate, but the most sensitive clauses covering confidentiality, indemnification, publications, intellectual property, and all not trial-specific aspects (even including general payment terms) can be covered by MSA upfront even before the study is planned.

The recent tendency shows that more and more Sponsors prefer to enter into MSAs with ‘their’ sites – sites that they have a long successful cooperation record, but why not to offer the MSA as the initial option to all the sites for potential future trials, where possible?

Efforts put into negotiation and execution of the MSA will surely be beneficial for all: Sponsors, CROs, sites, and – what is more important – for patients.