Studies link cohorts by a medical device, diagnostic tool or medication
ZEG Berlin conducts non-interventional cohort studies where study participants (the cohort) are linked by a medication, medical device or diagnostic tool.
Subjective patient experiences understood through careful study design
EURAS/INAS is a prospective, primary-data, patient-reported outcome, cohort study design that is adaptable to your needs. Using raw data collected from physicians and patients, we gather targeted and potentially sensitive information that is not easily accessed through normal big data pathways (e.g. claims / electronic medical record databases). Potential confounding variables such as sexual behavior, breastfeeding, pain, and mood, are not consistently collected by these sources.
We are currently conducting large prospective studies requiring the collection of sensitive and/or subjective data from the patients. The collection of this information would not be possible without the use of primary data collection and a carefully developed study design.
Finding the way through a constellation of disease medication and events
Occasionally a constellation of disease, medication, and events make conducting large-scale cohort studies or case-control studies unfeasible with targeted information on adverse events not easily found in registry data. Such was the case when ZEG Berlin conducted a small, retrospective, cross-sectional study on the treatment in pediatric patients living with hepatitis C. Using data collected from specialized pediatric hepatic clinics, we successfully described demographic and disease characteristics of patients within this population and estimated exposure to medications.
Comparison groups are not always needed to see clear patterns.
In specific situations, it may be useful to monitor the frequency of certain safety events in a new device or medication without comparison to a group of non-users. This is the case when there is no relevant comparator group, or the absolute frequency of a rare or very-rare risk is of primary concern.
ZEG Berlin has managed several single-arm studies in the US and Europe including prospective and retrospective drug utilization studies assessing prescription patterns and prospective medical device safety studies.