Quality Assurance

emovis lives for quality - in every area. That is why we invest a lot of time and effort in the quality assurance of our work. It goes without saying that studies are conducted strictly in accordance with IATA and ICH/GCP guidelines. Furthermore, study center-specific SOPs and SOPs relevant for homecare visits, regular training courses, and weekly team meetings are important tools used to achieve quality and constantly question processes. In addition, internal audits as well as audits initiated by the BVMA and sponsors are carried out at regular intervals at emovis to ensure that all processes are safeguarded. In this way, emovis achieves high quality in the execution of clinical studies and in cooperation with its clients, which is characterized by the following criteria, among others:

• Patient safety is guaranteed at all times.

• Data collection and data documentation are detailed and timely.

• Recruitment figures correspond to the forecasted values.

• Missing resources - equipment and personnel - are addressed immediately.

• Predictable "issues" in the area of protocols and eCRFs are communicated proactively.

• Regular internal audits and random quality control checks - in addition to for example, standard documentation checks, are performed.

• We conduct regular reviews of our processes.

Importantly for these kind of projects the team is trained - depending on position and relevance - according to the legally required EU standard (IATA International Air Transport Association) and ICH/GCP, which is updated every two years. Furthermore, emovis routinely ships patient samples, biological materials, or infectious substances within ongoing clinical trials via courier. Sponsors of other projects are also welcome to use this service. Regardless of whether it is a matter of substances such as diagnostic samples, specimens, or infectious cultures, the emovis team packs, (also on dry ice) and ships the samples professionally.

Since 2006, emovis has had its own SOPs, which comply with the principles of ICH/GCP and are regularly reviewed and updated as necessary. These SOPs always apply if the client does not have its own SOPs. The emovis SOPs describe all aspects of daily work and define procedures. Clients can view our SOPs at any time.

We are not a company of hierarchies and therefore do not like stubborn memorization. Instead, we choose a playful approach where our employees* regularly participate in internal SOP quizzes. In this way, we ensure that the information is always refreshed and that the team takes the SOPs and also updates to the SOPs positively.