eCRF and eDiary / ePRO

The entire SocraMetrics eCRF and eDiary/ePRO system is browser-based - no additional software needs to be installed. All you need is an internet connection and a browser.

Our eCRF is a flexible and cyber-secure system which is set-up according to your needs. We work according to internationally accepted IT-standards and our system is fully compliant to FDA 21 CFR Part 11 and EMA Annex 11 by following GAMP5 principles. We developed a modular system in line with our cyber security concept which is easily adaptable to your needs and the complexity of your project.

The eCRF provides all necessary information at a glance. The system's inherent speed due to modular design and reduced complexity is just one among numerous reasons which make our EDC exceptionally appealing – especially in trials with large amounts of data. Extremely short click paths and a highly intuitive input concept complete the picture. When users perceive the system as an integral part of the study team, we have realised our vision.

SocraMetrics eCRF system: Data entry form

Besides entering and storing the data,
our eCRF includes but is not limited to the following features:

mobile-friendly data entry
including dark-mode
complex randomisation
and stratification procedures
kit monitoring
edit checks at different complexity levels
which easily span different time points and different entry screens
time-saving Query process
which is easily understood even for sites without any trial experience
Sponsor Oversight: prompt reports and figures
of any data and protocol deviations (PD Tracker) in real time
a variety of data export formats
an efficient SDV
and release process
a comprehensive Audit Trail
fast export of blank and filled CRFs
for archiving and storage
data-driven email notifications
of any event

During set-up process, the level of complexity and required functionality of the system will be thoroughly discussed with you, tailored to your requirements and quickly integrated by our experienced team including User Acceptance Tests (UATs).

Furthermore, your study participants will appreciate our convenient browser-based eDiary/ePRO!

Volunteers can enter data on their own smartphone, tablet or any other device of their choice. In doing so, they do not have to disclose any personal information, such as email-addresses. We have integrated a sophisticated password recovery process, eliminating the need to store any non-pseudomised data.

Data collection in an intuitive and clear design will become part of the daily routine. Your subjects’ compliance will increase!

As the eDiary/ePRO is fully integrated into the eCRF system, study staff has real-time access to all diary data enabling them to perform compliance checks and contact volunteers promptly in case of any problems.

For more information you can download our info-flyer as pdf file.

Download eCRF Flyer (0.8 Mb) PDF

eCRF and eDiary / ePRO

Besides entering and storing the data, our eCRF includes but is not limited to the following features:

Besides entering and storing the data,
our eCRF includes but is not limited to the following features: