Inappropriate concomitant medication prescribing remains one of the major cause's
of protocol violations within clinical trials. Currently, protocol exclusion information
on concomitant medication use is distributed to medical professionals as paper documentation,
and it is therefore easy for a busy clinician to inadvertently prescribe an excluded
medicine. As well as having major implications for patient safety, inappropriate
concomitant prescribing leads to attrition of clinical trial populations, which
compromises the research process for investigators, and has resource implications
for the pharmaceutical industry.
CliniSafe's® Global "live pharmacist" technology improves study design by allowing
the protocol drug rules to be set up and managed electronically, so that a patient's
medication may be checked against clinical trial exclusion criteria at the point
of care. Using drug interaction decision support functions, CliniSafe has the potential
to eliminate unnecessary errors and subsequently improve patient safety.
Real Time Data OR Real Time Information
The benefits of manual and system alerts on the "near real time data" delivered
within EDC are well documented. CliniSafe's® "real time information systems"
further enhancing safety and protecting data.
CliniSafe's concomitant medication management platform supports disparate applications
and supports proprietary dictionary formats. Coupling between clinical management
and data management reduces error frequency and query management time.
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