The emovis study site features an extensive team and the entire staff is certified. Regardless of whether it is the gold standard of clinical research ICH/GCP or the authorization to send laboratory samples, (IATA), emovis places significant emphasis on the training and advanced training of its staff.
Die International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is an association of medical drugs authorities and the pharmaceutical associations in the USA, European Union and Japan, with the goal to unify the registration requirements of medical drugs in the ICH-regions. The GCP-Regulation is the “Regulation for Application of Good Clinical Practice with Regard to Inspecting Drugs for Administration to Humans (GCP-Regulation - GCP-V) “– The entire team at the emovis study site is ICH/GCP certified.
Sending patient samples, biological materials or infectious substances via air freight within the framework of clinical trials is a routine process. Transporting these substances is subjected to the statutory governance, such as hazardous goods regulations of the IATA (International Air Transport Association), which are constantly updated and adapted. The team in charge at the emovis study site has been trained in accordance with the legally mandated EU standard, because only parties with IATA certification are authorized to send infectious substances, such as diagnostic samples, samples for clinical trials and infectious cultures on dry ice.
The teams’ knowledge regarding emergency situations is also updated on regular basis. Regardless of whether the training is conducted by the in-house anesthesiologist or the emergency physician, or it is conducted by an external team – the SOPs and the additional high-level emovis requirements apply in this segment as well.