Pharmacovigilance Software Development

Adverse events reach your safety team through multiple channels simultaneously -- patients calling a phone line, healthcare professionals submitting via a web form, clinical site coordinators sending emails, and spontaneous reports arriving from literature monitoring. When each channel feeds a different inbox or spreadsheet, cases get duplicated, delayed, or missed entirely. We build a unified intake system that routes every channel into a single case database with a consistent data structure. Web forms capture structured data directly. Email-to-case parsing reads incoming messages and creates draft case records for a safety associate to review and complete. Call centre integration provides a guided data entry screen so operators capture the minimum safety data set on the first contact. Spontaneous reports from clinical sites and company representatives follow a defined submission path that creates a case record automatically. Duplicate detection logic compares incoming cases against existing records on key fields before a new case is opened.

Once a case is captured, it enters a structured medical review process that the platform enforces rather than relies on individual judgment. A triage step assigns seriousness criteria -- death, life-threatening, hospitalisation, disability, congenital anomaly, or other medically important condition -- and triggers the appropriate reporting timeline based on the outcome. Causality assessment captures the reviewer's evaluation of whether the suspected adverse drug reaction is related to the product, using standard terminology and the assessment methods your safety physician applies. The platform distinguishes between expedited and non-expedited cases and routes them to the correct workflow branch with the relevant deadline displayed. Cases requiring medical officer review are escalated with the full case narrative, patient demographics, concomitant medications, and prior medical history already assembled for the reviewer. Narrative generation tools compile the structured case data into a draft medical narrative that the safety physician reviews and finalises.

Each regulatory agency requires adverse event reports in a specific format: CIOMS I forms for MedWatch submissions to the FDA, MedWatch 3500A for US expedited reports, and E2B(R3) XML for electronic submissions to EudraVigilance and other ICH-compliant agencies. Building these files manually from case data is time-consuming and error-prone -- a single mapping error affects every submission generated from that case. We build automated file generation that maps structured case data to the correct fields in each output format, produces submission-ready files, and validates them against the relevant ICH E2B(R3) schema before a human reviewer approves them for submission. Output formats are configurable per regulatory market, so the same case data can generate a MedWatch for the FDA, an E2B XML for EudraVigilance, and a country-specific report for an additional market without manual reformatting. Submission files are stored against the case record with version history.

Regulatory agencies expect more than individual case reporting -- they expect you to monitor your aggregate case data for emerging safety signals and report findings in your periodic safety update reports. Signal detection in the platform runs disproportionality analysis across your case database, comparing observed adverse event frequencies to expected background rates using standard methods such as reporting odds ratios and proportional reporting ratios. Cases that meet signal criteria are flagged for clinical review and tracked through a signal assessment workflow that records the assessment decision, the data reviewed, and the outcome. Aggregate reporting tools pull the full case dataset for any time period and product scope, producing the case counts, seriousness breakdowns, and outcome data your PSUR and DSUR preparation requires. Case series review screens allow the safety team to review all cases for a specific adverse event term across the full product history.

Electronic submission to regulatory agency safety databases removes the manual step of uploading files through agency portals and creates a direct record of each submission with acknowledgement tracking. EudraVigilance integration connects to the EMA gateway using the E2B(R3) XML format, handles the ICH message acknowledgement workflow, and surfaces any validation errors returned by the gateway so the safety team can correct and resubmit without losing the submission record. FDA FAERS integration supports electronic submission via the FDA Electronic Submissions Gateway using MedWatch 3500A data or E2B(R3) format for manufacturers, and handles the submission acknowledgement returned by the FDA system. For pharmaceutical companies marketing products in multiple regions, the platform manages different submission obligations per market -- some agencies accept E2B directly, others require national reporting forms -- with each submission tracked separately against the relevant deadline and agency.

Every action on a case is logged with the identity of the user who performed it, the timestamp, the field changed, the previous value, and the new value. This audit trail is generated automatically by the system -- it does not depend on individual users remembering to document their actions. Cases are locked after submission to the regulatory agency, preventing any further edits to the submitted version. If a follow-up report is required -- new information received after the initial submission -- a linked follow-up case is created from the locked original, preserving the integrity of what was submitted while allowing the new data to be captured and a follow-up report generated. The audit trail is retrievable in full for any case at any time, formatted for regulatory inspection. Access controls enforce role-based permissions so data entry staff, medical reviewers, and safety officers each operate within the data access their function requires.