emovis GmbH

emovis is one of the best study sites in Germany, representing the greatest commitment level in cooperation with CROs and sponsors, as well as the especially valued interaction with CRAs. emovis is a dedicated study site that focuses solely and exclusively on the conduct of clinical studies. For this reason, the whole emovis team, made up of physicians, nurses, study nurses, study coordinators, reception and call centre, is not only trained and certified for clinical research. They are all focused and are exclusively dedicated to the correct conduct of the assigned studies and not any other task. This dedication – i.e., the exclusive devotion to clinical research – also applies to the emovis sleep laboratory. There are no medical practice operations running alongside the clinical research operations anywhere in emovis. Outpatient Treatment: Patients Visit the Site emovis is an outpatient study site. This means that all participating patients come to the study site for their visits and to receive new drugs. For this reason, emovis focuses on indications, which can be carried out in the outpatient department – except for individual Phase I studies whose participants emovis can admit effectively as inpatients into its sleep laboratory for the duration of the study. Focus on Phase II-IV emovis’ focus lies in Phase II-IV studies. However, emovis can also serve Phase I and Ib studies if the project fits well with the profile of the outpatient study site and sleep laboratory. In recent years, the focus for indications was in the field of neurology and psychiatry – thus, since its foundation, emovis has conducted more than 50 studies with the indication “depression”. In total, however, emovis reaches more than 120 indications in a number of therapeutic areas which are easily feasible and have also already been conducted. Phase I is Also Requested More and More Often In recent years, emovis has received requests for Phase I and Ib studies more and more often and has conducted studies in this area. For this purpose, the emovis sleep laboratory offers an outstanding opportunity to effectively “admit” participants as inpatients, and to “quarter” them in homely surroundings for the duration of the study. Precisely studies with an adaptive design that want to achieve an earlier proof of concept through the addition of patients in early phases, fit well with emovis’ profile. emovis' particular advantage – also in this case – is the rare combination between dedication, i.e. the exclusive devotion to clinical research, and the ability to recruit high numbers of patients in a high-quality manner in a short time. 34 Successful Audits – Even the FDA Was Here emovis now has a certain routine when it comes to sponsor audits. Due to the strict dedication of the study site and the ever-intense cooperation with clinical monitors, sponsor audits are always an occasion for emovis to look even closer – and to scrutinize every process at the study site again and again. Since its foundation, the study site has successfully passed 34 sponsor audits, including an FDA inspection in 2013, which could be entirely completed without a “Form 483” being issued.