Study Sites Services

The emovis team focuses entirely on conducting clinical trials. It starts with the qualified and prompt feedback of our executive management’s feasibility and continues with the competent and quick response with regard to our investigators’ study protocols and the preparation of the source documents by our study coordinators. These are the first steps guaranteeing that your clinical study is conducted according to protocol at emovis.

Detailed Services

  • Immediate review of feasibility or study inquiry  
  • Quick, centralized contract preparation
  • Routine submission of the required  ethic documents
  • Successfully recruiting patients with assistance of the database and advertising
  • Ethical demonstration of the study on the emovis patient website
  • Friendly consulting services for all interested study participants
  • Diligent anamnesis of the potentially suitable patients
  • ICH/GCP-compliant preparation of informed consent documents with the patient
  • Attentive and personalized patient support during the study
  • Reliably documented request of previous result records if the patient consents
  • Detailed  preparation of study-specific source documents
  • Accurate implementation of complicated clinical trials (Phase I-IV)
  • Reliable study support by the ICH/GCP-certified team
  • Competent compliance with the AMG and European Regulations
  • Interested, honest and valued collaboration with your CRA
  • Consistent compliance with the applicable study SOP  
  • Documentation of all study data without gaps
  • Long-term record archived in print and digital

Quality Assurance "Live It" – Don’t Just Postulate It

emovis "lives" quality – in all areas. Therefore emovis is investing a great amount of time and effort in quality assurance of its tasks. Study site-specific SOPs, frequent advanced training and weekly team meetings are important tools to maintain quality and continuously question the processes. This is how emovis achieves high quality standards in conducting clinical trials and in cooperating with its sponsors, who, amongst other aspects, are characterized by the following criteria:

  • Patient safety is always guaranteed
  • Collecting and documenting data is detailed and current
  • Recruiting numbers reflect the prognosis values
  • Absent resources, equipment and staff-related, are escalated immediately
  • Foreseeable  "issues" concerning  eCRFs are communicated proactively

Special Emphasis: Source Data

The source data is the heart of clinical trials. It initially only confirms the existence of the study participant. However, based on the source data we review the inclusion and exclusion criteria, make therapeutic decisions and extract study data. Therefore, emovis places special emphasis on detailed, verifiable, complete and high-quality source documents. All source data is available exclusively in paper form, because (currently) a German language documentation program meeting the FDA CRF Part 11 requirements is not available. Only the eCFR data carriers provided by the sponsors are enclosed in digital format; and those are reviewed on regular basis.

Work Process "Internal Source Data"

  • At the beginning of each study a center-internal template for documenting source data for this trial is prepared. The document is based on the progress of a clinical anamnesis, whereby sufficient space for documenting the results in flow text is provided.
  • The clinical anamnesis is supplemented by study-specific details, which are queried in the CRF later.
  • Each of the templates are identified by the study title and protocol number and are subjected to version control. Therefore, the documents can be verifiably adapted to amendments or corrected for other reasons during the progress of the trial.

Work Process "External Source Data"

  • Each study participant is asked to bring available medical records to the screening appointment on the scheduled date. We are not limiting ourselves to the results of the trial indication, but rather utilize all documents providing information on patient’s entire medical history. Provided, the patient has granted his consent, we copy the documents and include them in our files.
  • If the patient has provided a written declaration of consent, emovis will contact his primary care provider (CPC) and/or attending specialists.

The contact process is as follows:

  • The primary care provider or attending specialists are notified of the patient’s participation in the trial and asked to forward a short medical report.
  • Upon receipt of the medical report the information contained herein is compared to our documentation by our investigators.
  • If the information is contradicting, we will seek clarification and document it.