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EDC, IWRS and eCOA Services

Robust and secure eSystems – EDC, IWRS and eCOA – for clinical trials.

The right eCRF system is key to the success of your clinical trial. We have the expertise to help you make the right choice.

Choose the right eCRF system

Our experienced team contains certified eCRF study builders for Medidata Rave® EDC and Veeva Vault EDC. They support active decision making, ensuring you choose the right eCRF system for your project, including edit check programming and the creation of validation documentation for user acceptance testing (UAT). Fully documented test evidence of the entire UAT guarantees quality.

Our specialists will also build and integrate Interactive Web Response Systems (IWRS), Randomization and Trial Supply Management Systems (RTMS), electronic Patient Reported Outcomes (ePRO) and electronic Clinical Outcome Assessment (eCOA) systems, as well as other external data streams into your eCRF.

Our services cover:

  • Design, release, and management of eCRF systems that pass full UAT
  • Data Integrations into the eCRF for external data streams, such as lab data by creating Data Integration Agreements (DIA) and configuration of the data loads
  • Building and/or integrating IWRS/RTMS and ePRO/eCOA systems
  • User management for eCRF, IWRS/RTMS and ePRO/eCOA systems
  • User training with progress tracking via customized eLearning modules
  • 24/7 multilingual helpdesk support in partnership with the vendor
  • Support for the development and management of client-specific eCRF page libraries

Why choose SGS?

We are recognized as the benchmark for quality and integrity in clinical research consultancy. Our experts provide continuous input and review of eCRF design, enabling efficiencies in data management and statistical analysis and with extensive in-house eCRF page libraries that ensure consistency.

Optimizing Clinical Data and Biometrics Flow

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  • SGS Germany GmbH

Heidenkampsweg 99,

20097, Hamburg, Germany