eCRF and clinical data management

Data capture using paper case report forms has become increasingly rare in clinical trials. Instead, there is a trend towards direct data entry in electronic form.

With the validated and certified eCRF-system Studymate our company provides a completely web-based software solution for easy and intuitive capture of patient data. Since the year 2000 Studymate has been used in multiple national and international trials at academic institutions, CROs and pharmaceutical companies.

When it comes to designing individual eCRFs, client satisfaction is our central concern. In order to optimize results, we therefore work together in close collaboration with our clients during all phases of the project.

In addition to tailored design and validation of eCRFs, our company offers the required data management for the whole term of the eCRF.

Your advantages

  • Transparency: Status of recruitment and quality of data entry can be viewed by the sponsor at any time
  • Saving of time and resources: Subsequent digitalization of data is not required, so that the period between data capture and data analysis is substantially reduced
  • Remote-Monitoring: Monitoring is facilitated due to the possibility to observe the data entry process continuously
  • Flexibility: Studymate is completely web-based and no software installation is required. The system can be accessed 24 hours a day, so that data can be entered at any time and at any location
  • Higher documentation quality: Programmed warnings prevent the entry of values that lie outside of a pre-defined range 

Our service range includes

  • Individual and tailored electronic data capture via certified and validated eCRF-tool (compliant with GCP and FDA 21 CFR part 11)
  • User-Role-Management: Differentiated roles can be assigned to users
  • Data consistency checks inherent in the system: Automatic plausibility and completeness checks
  • Query-Management: Timely feedback within Studymate
  • Audit-Trail: Changes in data entry are saved and can be tracked
  • Electronic signature: Availability of a validated and tailored process
  • Safety reporting: Automatic notification of pregnancies and serious adverse events to responsible persons