How often do you face the situation when after clinical trial kick-off meeting you discover that section on the clinical trial agreement and site budget negotiation is just a couple of lines in the study project start-up plan, or is even missing? We bet it happens quite often. Then, when the absence of a fully executed CTA becomes a bottleneck for site activation, the project team starts to jump on the site contracts team´s head requiring to get the fully executed CTA right here and right now, that makes the working environment stressful for all: Sponsor, CRO, Site, and surely for the negotiators – all become literally anxious, and all the negotiation process becomes a ‘good’ sample of the anarchy.

The main reason for that is improper negotiation planning. If we require the sites to conduct the study in strict accordance with the protocol, then why we cannot require the other teams to adhere to the detailed project plan that includes the contract/budget negotiation? The answer is bitterly simple – in majority of cases the project teams may have some lack of understanding of the importance of CTA negotiation.

What do we do to mitigate the above mentioned anarchy? We develop a detailed negotiation project plan. It is not just another formal paper – it is a simple and powerful plan that explains who does what and when.

It can be quite extensive inclusive of fallback options or can be quite short describing essential aspects of the negotiation process, but anyway the negotiation plan should include:

List of the project team members involved in the contract negotiation, escalation and approval process. It is very important to define their roles in the process;

Allocation of the negotiators to particular sites;

Set-up process for the contract/budget templates (core, per-country and per-site, if applicable);

Site communication plan which defines who is the main point of contact, who shall be cc’ed on the emails to the sites, frequency of follow-up and manner of escalation;

Peculiarities of contract and budget escalations;

Tracking and reporting requirements;

Signature process and archiving management.

The above list shall be understood as ‘including, but not limited to’, it surely can be either longer or – though we would not advice that – shorter. It all depends on the study and Sponsor’s needs. For example, some project plans may include even naming conventions for emails, files etc., which is actually great to have on permanent basis.

It is also important to understand that whatever your project plan is, something can always go off course or happen unexpectedly . It doesn’t always mean though that the plan was not good enough. That’s why the project plan shall be a living document, shall be revised and updated on the regular or case-by-case basis.

Thus, definitely devoting time for creation of the negotiation project plan contributes to faster start-up, saving time and money for the Sponsor and surely nerve cells for all.