Real Time Patient Reported Data | WebScreener & Online Recruitment | Site Entered Data
In-home Patient Monitoring

:: Site Entered Data

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. This ability is the traditional EDC model that all eClinical companies have; however, 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.

An online Informed Consent workflow can be added into the system to allow electronic signing of ICDs by the patient, fully witnessed if required, and is maintained in a Part 11 compliant manner. 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 from any location by the patient at any time during the study.