A clinical trial is a very complex and complicated venture from organizational point of view. Even if it is perfectly planned, a lot of unexpected issues can happen during the trial. It often happens that at start-up phase – when all country regulatory approvals are in place – ‘suddenly’ sites cannot be activated because of the delays with contract negotiations. Surely, you would agree there is no start-up professional who didn’t face site activation delays due to contracts.

Let’s do some root-cause. Worth starting from the Bid Defence (‘BD’) stage. CROs fighting for a study often advertise shorter-than-average start-up timelines. This advertisement is often supported by some historical data which can actually be adjusted to look better. It is neither bad nor good – it is just the marketing reality. It is very often focused on regulatory submission and approval timelines; contract negotiation is left aside.

Bid defence success is surely a huge step for CRO’s business. The winner takes it all, including the responsibility for what was promised during the bid defence. Next step is more process-specific – it is Kickoff Meeting (‘KOM’). Ideally it should cover all the aspects of the trial planning, but as we mentioned above, it is hardly possible to cover everything. Average KOM is focused on very high-level things, it may not particularise country/site-level risks. Site contract and budget negotiation section of the KOM agenda may be quite short not allowing global contracts manager or local specialists highlighting all possible risks connected with their function.

Then, in course of the trial there are regular Sponsor calls where CRO reports the current status and escalates issues to the Sponsor. At some stage of the trial delays of site contracts negotiation become a spotlight. ‘All essential documents are collected, regulatory approvals are received, but the contract is not executed yet, thus we cannot start’ – pretty common thing you can hear at regular Sponsor calls.

As a result, Sponsors are unhappy with the delays, CROs start to involve more resourcing into contract work, Sponsor calls starting to be a bit embarrassing and frustrating.

Surely, delayed contract negotiations can result from a lot of factors. Yet seems contracts is not always taken good care of at stage of study planning. Overpromising at BD, not covering risks at KOM results in incorrect overall planning.

We are happy to see though that Pharmas took knocks on site contracts and pay huge attention to the stage of contract and budget negotiation providing very detailed and clear instructions and requirements, as well as closely tracking the historic data and ensuring good communication with local negotiators. Still, there is still some room for improvement for some other market players.

To address this, we create our own KOM over at CTA Focus and we explain in details the steps we need to take, countries were we can start working on contracts only after regulatory approvals, or previous experience and try to learn from every contract we close, so that we make our project teams aware of upcoming challenges.

We at CTA Focus strongly believe that overpromising and lack of transparency in planning of contract development and negotiation strategy can result not only in Sponsors’ frustration and CRO’s creating a not so good name, it impacts real peoples’ lives who are waiting the start of the therapy, and not executed contract simply cannot be the reason for them to wait longer.