Pharmacovigilance and translation part one: Addressing the challenges in pharmacovigilance
The effect of any drug in the world of pharmaceuticals must be constantly reviewed. Regulators and the companies themselves continuously have to know what the intended effect of their drug is, and if there’s any side effects or adverse reactions. The monitoring, tracking, recording and management of this is essentially what is known as pharmacovigilance.
Pharmacovigilance is a vital part of the drugs market, collecting data on any adverse events that take place and reporting these to regulators so any decisions that need to be made can be backed up by data and evidence, ensuring the right call is made every time.
Translation in this sector is important to make sure huge data-sets from trials and usage across the world and a range of different users and professionals speaking different languages can be assessed, translated and reported on in a timely and accurate manner.
Here, we take a look at a few of the challenges associated with the translation of pharmacovigilance.
The most important aspect of the world of pharmacovigilance is that findings can be turned around in a very short period of time. Whenever someone reports an adverse event in relation to a drug, the clock starts to tick, and due process needs to be completed very quickly.
Typically speaking, from the moment an adverse event is reported to the time details of this have to be passed to regulatory authorities, there are only seven days to get things done. For the translator, however, deadlines at this stage are even tighter. Translators typically need to translate the data within a day or less.
The reason for this is that the clinical researchers or pharmaceutical company involved need to evaluate the translations, assess how serious the issue is, triage it, then go through a review process and code the data to fit in with the correct regulatory terminology. What needs to be remembered, is that translation is only a small part of the whole process of an adverse event, and for that reason, all translation work needs to be carried out in a very short space of time to make sure the whole process can be carried out promptly.
To make sure we address issues around timeliness of translations in pharmacovigilance, we ensure that we appreciate and manage the 24/7 nature of the industry. Something can happen to anyone in the world at any time of the day or night, and the sector needs translators that can react to such events.
We do this by leveraging our global operations so even if a case arrives in the evening outside the hours, we have people in global hubs we can send the work to so we can chase the sun and have that continuous service available. We’re therefore able to deal with the turnaround challenges that we typically see in this process.
It’s incredibly important in any medical setting that accuracy is strictly adhered to, but this is especially important when it comes to the world of pharmacovigilance, where incorrectly translated data can have huge implications. When we’re translating in this sector, we’re dealing with units of measurement and specific drug terminology relating to a single product and the side effects it has had in a set context.
Should we happen to get it wrong when it comes to this stage of the process, especially in terms of units of measure, it can have serious implications on the review process. Something as serious as a minor miscalculation or mis-translation can see something judged to either be, or not be, an adverse event, when in reality the other outcome was actually the right decision.
For this reason, it’s absolutely vital that vigilant practices are undertaken. Making sure we take the time to not only translate correctly, but also to ensure our detailed QA process, providing certification of the translations following our ISO process has taken place is important. It’s also crucial that our translations have a related audit trail.
This is especially important for pharmaceutical firms and research organisations. If and when they get audited, if they have a product recall for example, they need to know who did what and when in order to answer any questions about the process. We can provide this with our audit trail.
Come back soon to learn more about the key challenges that exist in the world of pharmacovigilance in part two of our series.