S-IVRS / IWS

S-IVRS, the S-Clinica multilingual IVRS (Interactive Voice Response System) and IWS (Interactive Web System), is used by pharmaceutical and biotechnology companies from all over the world.

S-Clinica has managed a variety of trial designs across all phases (phase I to phase IV) of clinical studies, from very small to large scale (over 15,000 patients), scattered across more than 60 countries, including some that covered up to 40 countries simultaneously.

S-Clinica manages trials with any type of randomization and/or treatment allocation algorithm. To facilitate decision-making and monitoring of the trial, S-Clinica customizes a website that is specially designed for the study and which offers numerous reporting and trial management options.

O ur managers and specialists recognize the importance of responsiveness to the sponsor as well as timelines. S-Clinica excels at immediate customization of comprehensive IVRS and IWS systems, and at the proactive management of projects.

Key features:

• Central randomization of patients:
  • All randomization methods (permuted blocs or adaptive)
  • Eligibility control
• Treatment assignment to patients:
  • Multiple treatment assignment to a patient
  • Dose adaptation
• Event/visit tracking
• Emergency Un-blinding
• Management of patient recruitment:
  • Center closure
  • Center CAP
  • Cohort management
• Drug supply management
• E-PRO
• 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
• IVRS and IWS work in parallel for the same study
• Reporting
  • Real-time web reporting
  • Automatic customized report sending
  • Downloadable data for off-line use
• 24/7 Help desk
• GCP and FDA 21 CFR part 11 compliant

Key benefits:

• Real-time study management
• System use is facilitated by the creation of links
  • Avoid users doing things twice
  • Eliminate database reconciliations
  • Minimize the risk of error