PRAcarries out research into the safety and possibly the effect of medicines. Mainly with healthy volunteers and sometimes with patients. GCP Central was allowed to visit Zuidlaren, the specialized clinic where this type of research is carried out. We saw how Good Clinical Practice is carried out down to the last detail.
Strict protocol
Atomic clocks on the wall indicate the time. Because here everything goes exactly on the second. The administration of the medication, for example, but also the blood samples. Everything is also kept up-to-date in electronic systems, which are then passed over again. Our visit or when external people come to us as couriers is also carefully documented. For us it is already adjusting, for volunteers who participate in the research it also means quite a bit. Just to the toilet? First pick up the key. Grab a bite? Do not forget the meal regulations, and (of course) the time.
Alarm everywhere
All these rules are not for nothing, of course. Phase 1 research potentially has a higher risk because you are testing new medicines for the first time on healthy volunteers. Patient safety is therefore above all else. And you can see that. There is a crash cart in every room and each participant has an alarm bell around his neck. If something goes wrong, a doctor is directly involved. Despite the fact that it has a significant impact, healthy volunteers barely drop out during the research, says senior research physician Jan Jaap van Lier. Except for personal circumstances that have nothing to do with the research.
International
PRAWith its 70 beds (and another 70 in Groningen), Zuidlaren is the largest institution for Phase 1 research in the Netherlands. In addition, this clinic is well known in the world. There are assignments from countries such as India and Korea, where GCP standards may be handled differently. PRAhas experience with this and sends pharmacist / Qualified Person Arjen Akkerman around the world to see if the medicines are well developed on location.
It was a learning day. PRA Thanks for your hospitality
We like to visit other research places to see what GCP / WMO means in daily practice. If you want us to come to you, let us know! Contact us via info@gcpcentral.com.
