‘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.

Approaching QC stage means that a long and uneasy marathon of negotiation is completed and we can start collecting signatures. But let’s see if the QC is just a checkpoint to take breather or another important time and efforts consuming step?

Let’s be honest, in many cases QC is treated as a formality that is limited to ticking boxes of a QC form. It goes without saying, such approach is absolutely wrong and in many cases even dangerous. QC is not just a form, but a process.

QC allows to find and correct mistakes. Even the best negotiator is never mistake-free, especially when working under a clinical study involving huge number of sites utilising one and the same template. In this case most common mistakes are copy-paste errors, use of information related to another site (which is quite embarrassing) etc.

QC allows to make the agreement even more perfect, especially when the reviewer has an eagle eye. There are always people who can immediately spot formatting discrepancies even if these are not so evident.

QC allows to benefit from the experience of other colleagues. If the reviewer raises questions on the content of the agreement, it can facilitate early mistake detection and correction. That extra pair of eyes can go a long way and it can help tremendously a project well-being, as we all make mistakes, we can all be tired and under pressure to deliver at same time. Some of us are even perfectionists and strive for quality in everything they do. We do that in pairs, as its easier to have someone to count on when you need an extra check, it gives professional comfort to be able to count on a final check from someone you trust. QC builds teams.

QC saves money. If some material mistake survived QC, you will most probably need to negotiate an amendment. And in many cases this will be done free of charge for the client.

We at CTA FOCUS pay huge attention to the QC and have a very well-established process aimed to maintain the highest quality standards.