Clinical Trials Center

Are you conducting clinical trials with cyclotron produced PET tracers ?

Synektik will deliver the requested doses to your site.

We have 2 cyclotron sites in Poland delivering radio-pharmaceuticals to PET sites in Central Europe. Our Research and Development Center in Warsaw is dedicated to clinical trials, enabling on-demand production of novel PET tracers.

Every study is unique, which is why we make it our mission to be agile and responsive. At Synektik, we inspect and validate every process to ensure patient safety and timely delivery.

Aligning with a client

Each medical examination is unique, which is why we consider it our mission to be a flexible provider, always adjusting to the needs of our clients. The manufacturing process of radiofarmaceuticals is controlled and validated at every stage. This ensures the highest quality, patient’s safety and deliveries right on time.

Information regarding the impact of the activity related to the sources of ionising radiation on human health and environment

Perform custom synthesis of traditional PET tracers.

Perform custom synthesis of novel PET tracers.

Obtain clinical trial regulatory authorization for tracer production.

Production on demand.

Land and/or air delivery to site.

Ensure quality requirements are met and documented.

Obtain clinical trial manufacturing authorization for your tracer.

Timely delivery to your site.

Cyklotrony

The highest quality

Nasze produkty wytwarzane są w standardzie GMP (Good Manufacturing Practice) oraz zgodnie z obowiązującymi normami krajowymi.

Zobowiązujemy się do zapewnienia najwyższych standardów produkcji i kontroli jakości jakie obowiązują w naszej branży.

Posiadane doświadczenie i kompetencje pozwalają nam wytwarzać produkty radiofarmaceutyczne na potrzeby badań klinicznych i eksperymentów medycznych.

The radiofarmaceuticals production site is designed to adhere to GMP conditions as required by European Union GMP Directives. This includes controlled manufacturing cleanrooms, grade A hot cells for sterile dispensing of the radiopharmaceutical products and individual hot cells containing automated syntheses modules. These conditions allow us to efficiently and safely handle radiopharmaceuticals. Our quality control has dedicated instruments to test the final radiolabelled products before their release for human use. This includes high performance liquid chromatograms (HPLCs), gas chromatographs (GCs), gamma spectrometers, pyrogen testing equipment and other supporting lab instrumentation. These capabilities provide an efficient and safe environment to produce radiopharmaceutical products for clinical imaging and therapy programs.

Our reputation for reliability and responsiveness has resulted in our leading position on the Polish market. Our dedicated professional team is the key reason for this success.

Under EU permits, ¹⁸F- based radio-pharmaceuticals are being produced and delivered by Synektik to PET sited on regular basis. Our Research and Development Center delivers on-demand radiopharmaceuticals labelled also with ¹¹C, ¹³N and ¹⁵O.

For the list of available PET tracers please see.

About us

Our experience in the development, manufacturing, and delivery of radiopharmaceuticals dates back almost ten years. Our probes are delivered to PET/CT centers both in Poland and abroad. Our team, thanks to their creativity, has the ability to design high quality products that come directly from professionalism and extensive practice. We believe that success lies in the details.

In the backdrop of the ever-increasing demand for new and more sophisticated PET probes for experimental research and clinical applications, Synektik is your partner of choice for delivering radiopharmaceuticals to your clinical trials. From optimizing production to regulatory approval Synektik excels at every aspect of novel tracers delivery to clinical trial sites.

In treatment, there in an extensive on-going experimental research of clinical applications for novel PET probes. Radiotheranostics* is making in-roads to a new and promising area in personalized medicine. Here too Synektik is your partner of choice for delivering radiopharmaceuticals to your clinical trials.

Our customers are big thinkers who are pursuing the most challenging areas of study to advance the cause of personalized medicine. To support an ambition that big, we’ve put everything in place to take your clinical trials to success.

If you’re looking for a reliable partner that shares your commitment to developing life-changing diagnostics and therapies, we should talk.

*a treatment combining therapeutic + diagnostic.

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