E-clinical services

E-clinical trials routine - without a headache

 

Bits and bytes are no longer just nice to have in clinical trials: 

  • every day, e-clinical trials with state-of-the-art eCRFs solutions prove that they are user-friendly, reliable, flexible, fast and cost-efficient.
  • processes in so-called "paper trials" have been continuously improved by extensive use of e-clinical solutions.

Since 1996, Metronomia has run EDC studies with a number of different EDC/eCRF solutions. In 2006 we decided to fully rely on clincase® from Quadratek Data Solutions, a user-friendly and validated EDC solution (www.clincase.com). With our innovative, in-house developed technologies (scanTrace, IWRS), Metronomia plays a leading role in e-clinical services.

 

E-clinical trials services

For a successful e-clinical trial, the services needed when using an EDC system are at least as important as the technology itself. And it is because we are a clinical trial service provider, and not an EDC vendor that we understand the needs of our customers.

  • eCRF implementation, validation and documentation
  • Database mapping for export to SAS® or XML
  • CDISC compliant: ODM and SDTM format
  • Supporting multi language eCRFs
  • Online and on-site user training incl. preparation of training worksheets and training videos
  • Tailored service level agreements incl. first and second level support, international helpdesk
  • ICH-GCP and 21 CFR Part 11 compliant eCRF solution
  • Complete data management services for eCRF studies
  • Professional data hosting and archiving 

E-clinical tools

  • clincase® EDC solution
    clincase® provides a fully featured, 21 CFR part 11 compliant EDC solution, giving investigators, monitors and data managers a powerful but still easy-to-use environment for data entry, monitoring and data cleaning. clincase® has been specifically designed to fulfill the life science industry's desire to achieve more control over the EDC-based clinical trial process. With a modicum of effort, clincase® was integrated into Metronomia's existing team skills and processes.
  • scanTrace
    In order to significantly improve the standard data review process of paper CRFs, Metronomia has developed scanTrace - a browser-based online application to retrieve and review CRFs, queries and data. From wherever they are, CRAs, data managers or medical reviewers can access scanTrace with flexible user rights, over a secured website, so as easily to select CRF images, access related queries, create PDF reports or communicate on CRF related issues.
  • IWRS
    Metronomia's web-enabled Interactive Web Response System (IWRS) has been designed to facilitate central randomization and treatment allocation as well as to optimize, order, control and track study supplies in clinical trials.