EDC, IWRS and eCOA Services

EDC, IWRS and eCOA are key systems for your drug development, clinical trials and outcome assessment. Our dedicated EDC team provides eCRF design, edit check programming and creation of all validation documentation for User Acceptance Testing (UAT).

The team consists of certified eCRF study builders within Medidata Rave^®, Oracle InForm^TM and IBM Clinical Development, providing guidance on the best eCRF system choice to fit your trial and program specific needs. As eCRF systems are not stand-alone systems, we also build and integrate Interactive Voice/Web Response Systems (IVRS)/ IWRS and electronic Patient Reported Outcomes (ePRO) or eCOA systems as well as other external data streams into the eCRF.

Why choose SGS EDC IWRS and eCOA services?

We provide you with:

• Extensive experience in customized eCRF build in Medidata Rave^®, Oracle InForm^TM and IBM Clinical Development
• Certified in-house study builders that create eCRFs, targeted and customized for the study team and study protocol
• End-to-end input and review of CRF design by cross-functional teams, enabling downstream efficiencies for data management cleaning and statistical analysis
• Extensive in-house eCRF page libraries and support for the development of client-specific libraries to ensure consistency and to secure set-up timelines
• Fully documented test evidence of the entire UAT to guarantee quality
• Full support (development, testing and release) of IWRS, ePRO/eCOA systems and external data loads into the eCRF to maximize the data visibility for the study team through the eCRF

World-class EDC, IWRS, eCOA provision

We offer you unrivaled expertise in electronic data capture, interactive web response systems and electronic clinical outcome assessment.

We support the following systems:

• EDC
  
  • Medidata Rave^®
  • Oracle InForm^TM
  • IBM Clinical Development
• ePRO / eCOA
  • ERT
  • CRF Health
  • Medidata Patient Cloud
  • IBM Clinical Development
• IWRS/IVRS
  • Oracle Interactive Response Technology (IRT)
  • Almac
  • IBM Clinical Development
  • Medidata Balance

Our services include:

• 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/IVRS and ePRO/eCOA systems
• User management for eCRF, IWRS/IVRS and ePRO/eCOA systems
• User training with progress tracking via customized eLearning modules
• 24/7 multilingual helpdesk support in partnership with the vendor

To discuss your EDC, IWRS, eCOA requirements, contact us today.