One case flow for every source
Individual case safety reports reach a company from many directions: published literature, local journals, the safety mailbox, partners and other intake channels, and documents such as source forms. In Edriza they all enter the same case flow, so a case found in an article and a case sent by a partner are checked in the same way and end in the same E2B(R3) report.
- Mail Box reads the safety mailbox, sorts each mail, and picks out new reports and follow-up information.
- Intake receives reports from partners and other intake channels.
- Document Scan reads uploaded documents and extracts the case data.
- Live Scan and Local Journal bring in literature cases (see literature monitoring).
The steps of a case
- Product check. Is the suspect product one of yours, and is the case your responsibility to process?
- Validity. Are the four minimum criteria of ICH E2D and GVP Module VI present: an identifiable reporter, an identifiable patient, a suspect product and an adverse reaction? Is it a duplicate of a case you already hold, or a follow-up to one?
- Seriousness and causality. Seriousness follows the ICH E2A criteria: death, a life-threatening event, hospitalisation or its prolongation, persistent or significant disability or incapacity, a congenital anomaly, or another medically important condition. Expectedness is assessed against the reference safety information, and causality as your SOP defines it.
- Data entry. Patient, reporter, products, reactions, tests and medical history are entered into the case, with reactions and history coded in MedDRA, and a narrative is written.
- QC. A quality-control agent compares the case with the source. Anything it cannot confirm goes to one of your experts.
- E2B(R3) XML. The case is converted into an ICH E2B(R3) message and checked against the E2B(R3) schema (XSD) before it can be sent.
- Submission. The report is submitted to the regulatory authority or partner, and the acknowledgement is tracked until it is received.
Timelines and follow-ups
Reporting timelines start on day zero, the day the company first receives the minimum information. Under GVP Module VI, for example, serious cases are due within 15 days and non-serious cases within 90 days for reporting to EudraVigilance; other authorities have their own rules. Edriza records day zero for each case and shows the due date, so nothing waits unseen in a queue. Follow-up information is linked to the original case and produces a new version of the report, not a new case.
Where people come in
Every case is processed by two independent AI agents, and a QC agent checks the result. When the agents agree and the case is clear, it moves on without waiting for anyone. When they disagree, when information is missing, or when your SOP says a person must decide (for example on causality or on a medically important event), the case goes to one of your experts with the evidence and the open question. People handle only the cases that need a decision, and every decision is recorded in the audit trail with who, when and why.
XSD-checked E2B(R3) output and regulatory authority reporting
An E2B(R3) message that an authority rejects is a late report. Edriza checks each XML against the E2B(R3) schema (XSD) before submission, and keeps the message, its validation result and the acknowledgement with the case. If an acknowledgement reports an error, the case is reopened for correction rather than left behind.
One platform for the whole case
Intake, assessment, coding, QC, E2B(R3) generation and submission happen in one platform, with one sign-in and one audit trail, so a case never has to be exported from one tool and keyed into another. Read how PV automation with AI keeps your experts in control, or contact us.