Call E-Mail Contact page
eCRF

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.

eCRF

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.

SocraMetrics eDiary / ePRO

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

Download eCRF Flyer (0.8 Mb) PDF

We will answer your questions.
Dipl.-Ing. Stephan Herrmann is at your disposal.

Don’t miss GBHI 24!

We are happy to share the upcoming 6th International Workshop - GBHI 2024, hosted by the PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative. We at SocraMetrics push advancements in bioequivalence standards, with strong expertise in:

  • Transdermal therapeutic systems
  • Long-acting injectables
  • Orally inhaled drug products

It is our honor to announce that Barbara Schug of SocraTec R&D will be serving as a co-chair for this event, while Ralph-Steven Wedemeyer from SocraMetrics will use his elaborate expertise as part of the workshop planning committee. Join GBHI 2024 and be a part of the pivotal discussions that will lay the scientific foundation for the ICH M13 follow-on document that will set global standards for MR dosage forms.

Don't miss your chance to be a part of GBHI 2024, April 16-17, 2024, in Rockville, Maryland, US. Read the GBHI 2022 report and register for GBHI 2024.

Join us in advancing bioequivalence!

Program GBHI 2024