‘Escalation’ is usually treated as some very strong word meaning someone is in trouble causing some goose bumps when one sees this word in email subject line. For clinical research operations, escalation is more like a routine (depending on the severity, of course). During contract negotiations, the negotiator deals with the escalations every other day (exaggerating - let’s say, often) being not an object for escalation, but the one who initiates escalation.
Finalization of the budgetary part of a clinical trial agreement is very often more complicated and more time consuming than finalization of the legal language. Many sites even prioritise negotiation of ‘numbers’ over negotiation of ‘words’. Luckily, in some countries those ‘numbers and words’ are standard and recognised at country, region and site levels as being non-negotiable. But, when it comes to those site that do not have their standard, all the fun begins.
There are a few systems and databases used to define country-level fair market value (FMV) of clinical trial procedures and visits. These systems help a lot to build up a site budget that is used as a starting point for negotiation. But is that fair market value really fair?
We see at times that the final site budget can significantly vary from the initial FMV-based template. Does it mean that the template was not good - or ‘fair’ - enough or there are some other reasons behind? Let’s try to figure out and review some factors.
The idea of electronic signature is efficient on many levels - it saves time, costs and the planet, by being more environment friendly. Taking into account all the advantages of the electronic signatures, why do we still have to print out contracts and collect wet-ink signatures? Let’s review some reasons.
Negotiators spend quite a lot of time on project calls. Nothing special about this - regular or ad-hoc calls is something treated as a daily routine, but sometimes attending calls eats enormous amount of the negotiator’s time, which is quite risky: how one can efficiently negotiate if there is no time for that.
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.
Contract negotiation in clinical trials is a very creative and many-sided process. It may be not that evident - some say, what is the difficulty to populate the template with site-specific information, add the budget, negotiate in accordance with the pre-setup parameters - and that’s it. If that statement is correct, then why Pharmas and CROs have separate site contracts departments?
There are 180 currencies in the world, and almost all of them can be converted into one another. Currency conversion became quite usual part of our lives, especially for travellers, and absolute routine for international business.
Conversion can still be a challenge, especially when ‘archaic’ ways of doing things apply. When it comes to clinical trial payments, let’s review some situation:
During the pandemic lots of clinical trial companies and even some administrative staff of the sites were literally switched to home-based regime of work. Since every crisis is believed to be a combination of ‘danger’ and ‘opportunity’, forced working from home (“WFH”) really implies a danger, potential or actual, for a well-established normal way of work as well as an opportunity for the companies to efficiently respond to the pandemic, save business and employees.
‘QC’ is surely one of the favourite abbreviations of contract negotiations. It stands for Quality Check and is what we do once we finalize contract and budget negotiations and we are ready to move to signatures. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements". In our business we make sure that the information in the clinical trial agreement is correct, accurate and reflects what was actually negotiated between a Sponsor and a clinical site.
Handover, according to the Cambridge Dictionary, is the act of giving responsibility for something to another person, or the period during which this happens. Looks simple, like you take the baton from one person and run further. When it comes to contract negotiation handover, things are usually more complicated.