S-IVR/IWR

S-Clinica's multilingual single-platform IVRS and IWRS are robust, scalable and highly customisable solutions that power global clinical trials.

It is easy to control and manage key clinical trials through a centralised database that is accessible in real time by phone or via the internet.

S-Clinica excels at customisation of comprehensive IVRS and IWRS and at proactive management of projects. To facilitate decision-making and monitoring of the trial, S-Clinica customises a website that is specially designed for the study and which offers numerous reporting and trial management options.

Key features

• Any study design (incl. adaptive)
• Central randomisation of patients
  – Any randomisation method (permuted blocs or dynamic)
  – Eligibility control
• Treatment assignment to patients
  – Multiple treatment assignment to a patient
  – Dose adjustments
• Event/visit tracking
• Emergency Un-blinding
• Management of patient recruitment
  – Center closure
  – Center cap
  – Cohort management
• Drug supply management (see separate product description page)
• ePRO (see separate product description page)
• Integration of data from central labs and central readers for
  – Verification of eligibility
  – Stratification
  – Dose adaptation
• Link with EDC and CTMS
  – Real time bi-directional data transfer
• 24/7 telephone access in any language
  – System automatically selects local language
  – Any other study language is available upon user request
• Reporting
  – Real-time web reporting
  – Automatic customised report sending

Downloadable data for off-line use

• 24/7 Helpdesk
• GCP and FDA 21 CRF part 11 compliant

Key benefits

Real-time study management.

IVRS and IWRS are developed simultaneously.

• Two systems in parallel for the same study, same sites
• Smart system set up approach
• Reduced cost and timelines because of simultaneous programming

System use is facilitated by multiple links.

• Avoid action redundancy
• Eliminate database reconciliations
• Minimise the risk of error