In addition to our robust ePRO solution, Maaguzi provides sites the ability to enter subject and clinical data at site visits, during telephone interviews and follow-ups. OutcomeLogix has integrated workflow logic and validation control that guides the user through the correct path for each iteration. Sites may also check the status of patient Informed Consent and ePRO compliance and completion. All study data is accessible in real time for review, cleaning and reporting by study team members.
In addition to the traditional site and patient entered data, OutcomeLogix offers a robust user matrix that allows a virtual limitless type of roles to be included in the data collection. These include pharmacists, medical monitors, site managers, third party adjudicators, etc… These expanded functions allow everyone associated with the project a unique (blinded or un-blinded) view relating to their specific needs.
An online Informed Consent workflow can also be added into the system to allow electronic signing of ICDs by the patient, fully witnessed if required. The system maintains full version control of each ICD and type required whether it be local or central IRB. All ICDs are time and date stamped and can be inserted into the protocol specific workflow to ensure data is not entered into the system unless the correct type and version of ICD is signed.
If a new ICD or version is required, the OutcomeLogix architecture allows for this and will force the workflow based on IRB approval and regulatory readiness of each site.
Each ICD signed can be reviewed and printed by the appropriate staff based on sponsor requirements. All ICDs can be viewed and printed by the patient at any time during the study.