Fre 24 maj / År 42 / Nr 1 2024

Malmö-based trial center clears FDA inspection

PharmaSite is an independent center for clinical trials, located in Malmö but with a global perspective. Meeting FDA regulations, PharmaSite is an important partner for many CRO:s and pharmaceutical developers worldwide.

The research- and knowledge-based company PharmaSite is involved in both national and international studies of pharmaceuticals from Phase II through Phase IV.
The company was founded by clinician Pekka Koskinen just over five years ago under the name Centre for Clinical Trials, operating from Medicon Valley with a catchment area of over 1.5 million people.
The aim of the business remains the same today; a swift and accurate recruitment of patients into clinical trials.

The birth of PharmaSite
Dr. Koskinen identified an increasing need to carry out pharmaceutical studies during his previous employment within the public healthcare system in Sweden. It became increasingly difficult to carry out studies together with his ordinary work as a physician and eventually he started the center as he saw the need for his services increase.

The last years clinical trials have however diminished in Sweden and to meet up that, Swedish Trial Network was founded by Dr Koskinen in 2013. It consists of six similar private trial sites throughout Sweden. The network can include a major part of the Swedish population into trials, and all its members have a large experience of clinical trials.

Meeting FDA standards
Pharmaceutical trials are complex and highly regulated. “We are able to meet the highest standards and regulations in the world, thus being an important partner for many CRO:s and pharmaceutical developers worldwide”.
Dr. Koskinen underlines that PharmaSite recently passed inspection by the FDA, which is considered to maintain the strictest regulatory standards in the world. Two years earlier, PharmaSite exceeded the standards set by the Swedish MPA, Medical Products Agency. On top of that Pharmasite gets audited by the sponsors several times a year, mainly as a result of their high recruitment into studies.