A rescue study is as such a challenge. According to some sources almost 50% of clinical trial programs end up with rescue status due to various reasons: these can be imperfections in the study design, failed enrolment expectations, regulatory approval delays, poor study management etc.

For a contract negotiator the rescue study is quite a headache requiring concentration of all resources. Taking on a rescue study for figuratively means taking control of the falling plane – you shall quickly investigate the reasons of the critical situation and take urgent measures to put things back on track.

This is not an easy task evidently, especially when the negotiator takes something ‘half-negotiated’ and previous negotiation was not running well. As a real-life example, the contracts negotiator takes over the project which has not been attended at all within a year. Communication with the site has been quite poor, the sites being ’not attended’ became not quite interested in active negotiations of the budgets and clinical trial agreements. Situation was even more complicated with the lack of previous correspondence, so the negotiator had no clue what was sent to the site, what was reviewed etc. To add, the pressure from the study management team has been very high requiring the negotiator to execute the agreements ‘just right now’.

Such situation is very tough, yet it is something we are facing quite often. What shall the negotiator do in such crisis?

First of all, don’t panic. Cool head is essential. Acknowledge the understanding of urgency and importance to the study team and assure them you are doing your best to negotiate the budgets and agreements as soon as possible. Don’t be overpromising though – always provide realistic projections.

Second, set-up a good communication chanel with the sites, present yourself and provide your contact details. Never complain about previous negotiation gaps, be honest, yet diplomatic. Reputation risk in such cases is very high, so it is essential for the contracts negotiator to mitigate this.

Third, define priorities. This seem be quite a cliche, however it will allow to define the plan for further work and deliveries. Trying to do everything at once will create even more confusion or delay.

Following these simple rules allows to make the work on rescue study an interesting journey contributing to the experience of the negotiator working in non-standard situations, it toughens up professionally.