Study process

After your request has been received via feasibility@emovis.de, you will receive initial feedback from us regarding the feasibility of your study as quickly as possible within three days.

In a joint meeting with the management of our study site and our investigators, we check whether we can carry out the study at our site and whether we can address your study-specific requirements. Above all, special requirements exist regarding the premises, the personnel carrying out the study and, of course, the patient population sought.

We aim for a speedy and streamlined contract negotiation. During the contract negotiations, the study budget is determined, among other things.

In principle, a planned clinical study may only be carried out if it has been reviewed and approved by the responsible ethics committee. For this reason, our employees work closely together to compile all the documentation required for submission as quickly as possible. In the event of ethics committee approval, the study is presented on our patient website www.studien-in-berlin.de in accordance with the ethical requirements.

As soon as the ethics committee has given its approval, i.e. permission to conduct the study, the study can be initiated. For this purpose, the respective investigator, and their deputy, as well as the representatives of the sponsor or the CRO come together. At this point, study-specific training is conducted, for example regarding the study protocol, laboratory procedures, and portals. Furthermore, the study material is carefully reviewed, and open questions are discussed or clarified. All this serves to ensure that the study runs as smoothly as possible and is of the highest possible quality.

The recruitment of suitable and cooperative study participants is an essential aspect for the success of a study. We rely on our extensive database, which may contain suitable participants. In addition, we make targeted use of our diverse marketing strategies to recruit further participants. In doing so, we exercise maximum care and sensitivity, especially because texts for the recruitment of patients must, in principle, be approved by the ethics committee before they can be used. In addition to these study-specific marketing campaigns, emovis also employs more general recruitment strategies. These aim to regularly draw the attention of potential study participants to the possibility of participating in a study with us. Our Patient Access Group is responsible for the recruitment of study participants. More information is available here.

After approval by the relevant ethics committee and the official initiation, the study will begin. The implementation of your study by us is divided into the following steps:

• Careful anamnesis of the people interested in participating in the study
• Obtaining ICH/GCP-compliant informed consent from patients
• Obtaining reliably documented previous findings (provided patient approval has been given)
• Detailed preparation of study-specific source documents
• Exact execution of even the most complex studies (phase I-IV)
• Reliable supervision of your study by our ICH-GCP-certified team of staff
• Consistent compliance with the AMG and European regulations as well as the protocol applicable to the individual study
• Attentive and compassionate patient care
• Interested, open and appreciative cooperation with your CRA
• Complete documentation of all study data

As soon as enough suitable patients are available for the study, we stop our recruitment activities.

In this phase we check whether all the relevant data has been completed or whether further data needs to be added.

In this section, the monitor checks whether all the data collected during the study is coherent and whether there are any open questions that need to be discussed before the study can be completed. Furthermore, any S/AEs that may have occurred are followed up on and clarified. Subsequently, all the study data is sent to us in electronic form (eCRF). We archive this for a period of at least 15 years. In addition, we usually receive a Final Study Report containing the final evaluated study results. In addition, any previously missing documents are sent to us for forwarding to the ISF.