Following our article on negotiation timelines projection, we decided to touch another point that is usually sensitive to our contract negotiators, and consequently, to their managers, consequently, to the overall clinical trial teams.

This is Contract Negotiation Trackers.

Across the industry ‘Trackers’ is often treated as something scary – as scary as Harry Potters’s ‘You-Know-Who’, ‘He Who Must Not Be Named’.

Completing trackers is a part of our day-by-day work though. Clinical trial involves a lot of professionals performing variety of functions – clinical, legal, regulatory, financial, so evidently to keep everything on track you need to have some instrument. And a tracker can be such instrument.

Some companies utilize Excel trackers, some use web-based systems, in both cases the most important point is what you present as an update. Tracker update is not usually a formal thing – it must be informative. Let’s review some typical mistakes one can make for regular weekly tracker updates:

– No update since last update

What does it mean for a person who is far from contract negotiation? – It means that from the moment when the tracker was previously updated the contracts negotiator did literally nothing. He or she didn’t reach out to the site, didn’t follow-up. Of course, if a contract is on accurate update is ‘No update’, but adding ‘…as a study is on hold’ makes it more informative.

– Site estimated their review timeline as 3 weeks

And after that the negotiator doesn’t provide anything new within upcoming three weeks. Can this update be frozen for three weeks? Definitely not. The contract negotiator is due to follow-up with a site, asking if they have any queries so far – this must be visible and put into the tracker.

– Call to the site – no response

This happens. But why not to add the date of next follow-up?

– Call to the site – Mr. Smith responded saying he was busy, that’s why he couldn’t start review of the contract, also he was away for two days visiting his mother-in-law in a city which is 500 km far from site’s location as she had anniversary.

If one was project manager reading this update, one would have a) spent a lot of time reading this, b) received a lot of not relevant info, c) zero understanding of what is going on with the negotiations (who is Mr. Smith, for a start?). Being detailed is good, but don’t overload your tracker with not-relevant info.

For regular updates it is suggest a basic formula (surely, it can vary basing on the Sponsor’s requirement):

Date of action – method of contact (phone call, email etc.) – who was contacted (role, not name) – result of contact; date of next contact

i.e. 11Jun2019 – call to PI – PI confirmed receipt of the budget and started review; next follow-up – 13Jun2019.

This is short, yet understandable and informative for those who are not dealing with contract negotiation, but who need to be up-to-date.

So, the trackers are not that scary if they are updated timely and to the point. It takes only couple of minutes to provide an update, and if the quality of the update is good the negotiator wins a lot of time for actual work instead of clarifying what this or that update means.