Effective clinical trial management requires timely access to accurate data.
How are the sites performing? Which need additional resources? Are things running efficiently? Where are the budgetary risks?
Clinical Research Associate (CRA) play a big role in identifying issues and shortfalls, and our CRAs are among the best — but their time is better spent addressing issues that support the collection of high-quality data. Likewise, project managers need to maintain a broad view and avoid getting mired in the details. We’ve answered these needs with eMonitoring, a data driven, systematic approach to clinical monitoring. eMonitoring makes information on every trial readily available to those who need. It continually assesses 30 to 40 key risk indicators, and a central monitor assigns issues to the right people for research and resolution. CRAs stay focused on ensuring high-quality clinical data are provided by sites — and with consistent access to high-quality data, project managers have better visibility into how the study is performing and can better respond to changing needs.
Our skilled and well-trained CRAs ensure the highest quality review of data and effective interaction with study sites.
Our CRAs conduct on-site monitoring visits throughout the study to:
- Oversee data collection
- Review source documentation and case report forms
- Ensure regulatory compliance
- Resolve data queries
- Conduct interim analyses as requested by clients
MediMonitorius is dedicated to employing and retaining well-qualified CRAs who:
- Are required to successfully complete a residential U.S. Food and Drug Administration (FDA)-accredited foundation program
- Have demonstrated site monitoring proficiency to MediMonitorius management before being allocated to a study
- Are typically dedicated to one protocol at a time to maintain quality
In Europe, are assigned to monitor sites in their home countries, providing understanding of local languages, regulations, customs and business practices.