Healthcare IT Software's Adverse Event Reporting solution tracks reported adverse events and manages the processing of all cases from initial triage through reporting and case closure.
Drug Safety users can accurately and efficiently record events and products (suspect, company, prior, and concomitant), code terms against industry standard thesauri, conduct seriousness, causality, and expectedness assessments, and determine report ability of adverse events to appropriate health authorities.
For safety cases that are reportable, the system supports a multitude of standard drug safety reports for paper and electronic reporting to meet expedited and periodic reporting requirements.
With clear quantification of:
- Abnormal lab values
- Surgical complications of transplant
- Subjective reports by the participant that meet AE criteria
- Clinically significant abnormalities found upon exam or through tests and procedures
We grade and qualify the Event:
- Grade 1, Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required
- Grade 2, Moderate: Mild to moderate limitation in activity –some assistance may be needed; no or minimal medical intervention/therapy required
- Grade 3, Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required and hospitalization possible
- Grade 4, Life-Threatening: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required; hospitalization or hospice care probable
Our reporting platform provides flexible mapping and configuration to meet the complex and varying requirements of global regulatory authorities.