SIS
REPORTING MANAGEMENT

What is SIS?

SIS is our Safety Information Solution. It allows you to record, evaluate and monitor adverse events reported by health professionals, regulatory authorities, and consumers.

See the main benefits when using SIS:

Evaluate causality using algorithms such as Naranjo and Karch & Lasagna

Record treatment evolution and export reports to XML in E2B format, enabling submission

Classify events, related diseases, and product indication through the MedDRA dictionary

Get reports and indicators that support the improvement of products and processes

See the main features of SIS:

• Registering spontaneous reports of health professionals, consumers or regulatory entities, literature reports, clinical studies, and bioequivalence;

• Recording narrative, patient data, report, suspicious and concomitant products, related diseases, exams and adverse events (adverse events or reactions, quality deviations, ineffectiveness, incorrect use, intoxications, and others);

• Possibility of recording pregnancy data when applicable and insertion of attachments and tasks;

• Sending Notifications and Alerts on deadlines and dates, such as deadline for notification to the regulatory entity, carrying out follow-ups, and others;

• Causality analysis using Naranjo and Karch & Lasagna algorithms;

• Registering patient evolution regarding the adverse reaction.

• Classifying adverse events, diseases, and indications for product use using the MedDRA dictionary;

• Exporting XML reports in E2B R3 format;

• Issuing standard reports such as CIOMS and full case file;

• Issuing reports and indicators on reports and adverse events;

• Managing E2B files issued, submitted and canceled;

• Integration with other corporate systems such as SAC, CRM, and ERP.

Meet RAS,

our solution for Regulatory Affairs