The pharmacovigilance software market has two ends. At one end, enterprise platforms like Veeva Vault Safety and Oracle Argus serve large pharmaceutical companies processing thousands of ICSRs per year. At the other end, there is nothing — just email, spreadsheets, and improvised workflows. Small and mid-size biotech companies with active INDs have been building their safety programs in that gap for years. AE Connect was built to fill it.
The Problem Nobody Solved
Here is how adverse event intake actually works at most small biotech programs: a site coordinator calls a safety desk number. Someone takes notes in a Word document or a spreadsheet. That document gets emailed to a drug safety inbox. A PV specialist — often a contractor working part-time — eventually opens the email, tries to reconstruct the case from the notes, manually codes the adverse event in MedDRA, drafts a narrative, and builds the ICSR in whatever tool is available. If you are lucky, there is a validated safety database at the end of that chain. If you are not, the ICSR gets assembled in a Word template and submitted as a PDF through the legacy MedWatch process.
That workflow is fragile at every step. The notes are incomplete. The clock-start is ambiguous. The MedDRA coding is inconsistent from case to case. The narrative is built from memory and partial information. And none of it — not the spreadsheet, not the email chain, not the Word document — constitutes a validated system of record under GAMP 5 or 21 CFR Part 11.
The FDA's April 1, 2026 mandate requiring E2B(R3) electronic ICSR submissions made this problem impossible to ignore. You cannot produce a compliant E2B(R3) XML file from unstructured intake data. The format requires validated, structured data elements across more than 100 fields. If the data was not captured correctly at first receipt, you will spend hours reconstructing it before you can submit anything — and you are doing that reconstruction on a 7-day or 15-day regulatory clock.
Why Enterprise Tools Do Not Fit
The obvious question is: why not just use Veeva Vault Safety or Oracle Argus? For large pharmaceutical companies processing hundreds or thousands of cases per year, those platforms make sense. For a small biotech with one or two active INDs and a team of three people handling drug safety, they do not.
Enterprise PV databases are priced and scoped for marketing authorization holders. Implementation timelines run six to twelve months. Annual licensing costs are measured in hundreds of thousands of dollars. The validation burden requires dedicated IT and quality resources that a ten-person biotech does not have. And critically, they solve the case processing and submission problem — they do not solve the intake problem. You still need to get structured data into the system, and most enterprise platforms assume that data arrives from a clinical database or a CRO, not from an unstructured phone call with a site coordinator.
Small biotech programs need something different. They need a structured intake layer that captures the right data at first contact, manages the case through a compliant workflow, and produces E2B(R3) ready output — without requiring a six-month implementation or a dedicated PV IT team to maintain it.
What AE Connect Does
AE Connect is an AI-powered adverse event intake and ICSR preparation platform built specifically for small and mid-size biotech companies with active IND programs. It was designed from the ground up around the actual workflow of a small drug safety team, not the workflow of a large pharmaceutical company's global safety organization.
The platform covers the full intake-to-submission workflow in one validated system:
Structured Intake Forms
Guided intake forms capture all minimum E2B(R3) data elements at first contact — reporter qualification, patient demographics, event details, product information, and seriousness criteria. Available in 10 languages with RTL support.
AI-Assisted MedDRA Coding
Adverse event descriptions are automatically mapped to MedDRA preferred terms and system organ classes, with confidence scoring and human review workflow. Eliminates manual lookup and reduces coding inconsistency across cases.
Timeline Tracking and Alerts
Clock-start is captured at intake and 7-day and 15-day regulatory deadlines are tracked automatically. Escalation alerts fire before deadlines are missed — not after.
7-State Case Workflow
Cases move through a structured workflow from intake through triage, medical review, causality assessment, narrative generation, and submission preparation — with role-based access controls at every stage.
E2B Narrative Generation
AI-generated case narratives structured for Section H of the ICSR, built from the structured data captured at intake. Reduces narrative drafting time from hours to minutes while maintaining the medical precision required for regulatory submission.
Signal Detection
Aggregate signal detection across cases in the system, surfacing patterns in adverse event frequency, severity, and MedDRA clustering that warrant medical review — without requiring a dedicated signal management team.
The platform is validated as GAMP 5 Category 5 and fully compliant with 21 CFR Part 11, with electronic audit trails, role-based access controls, and complete validation documentation — User Requirements Specifications, Functional Requirements Specifications, Installation and Operational Qualification protocols, and a Risk and Traceability Matrix — available to client organizations to support their own IQ/OQ qualification activities.
Who It Is Built For
AE Connect is designed for three types of organizations:
Early-phase biotech companies with active INDs that are handling adverse event intake through ad hoc processes and need a validated, compliant system of record before their next FDA inspection or audit. These organizations often have one or two people handling all drug safety functions and cannot afford to spend six months implementing an enterprise platform.
Clinical-stage biotechs transitioning from CRO-managed pharmacovigilance to an in-house function. As programs mature, sponsors frequently bring PV in-house to reduce cost and improve oversight — and need a platform that can support an internal team without the infrastructure overhead of enterprise software.
Small pharma organizations with established safety programs that need a dedicated intake layer to interface with an existing safety database. AE Connect integrates with any safety database, including the one an organization already runs. That database remains the system of record.
- Structured adverse event intake in 10 languages
- AI-assisted MedDRA coding with human review workflow
- 7-state case management with role-based access (5 roles)
- Automated 7-day and 15-day timeline tracking and alerts
- AI-generated E2B(R3) case narratives
- Signal detection across case portfolio
- PDF case export for case record documentation
- GAMP 5 Category 5 validated, 21 CFR Part 11 compliant
- Full validation documentation package included
- Hosted on AWS with SOC 2-aligned security controls
The Bottom Line
The pharmacovigilance software market has had an unaddressed gap for years. Enterprise tools are too large, too expensive, and too operationally complex for early-phase biotech programs. Nothing purpose-built for small sponsors existed between those platforms and a shared spreadsheet. That gap is where compliance risk lives — in the unstructured intake process, the missing audit trail, the reconstructed case narrative, and the missed 7-day clock.
AE Connect was built by pharmacovigilance practitioners who have worked in that gap firsthand. It is not a scaled-down enterprise platform. It is a purpose-built intake and case management system designed for the actual resource constraints and compliance obligations of a small biotech drug safety program.
If your team is managing adverse event intake through email, spreadsheets, or an ad hoc process, and you have an active IND and E2B(R3) submission obligations, we would be glad to show you how AE Connect works in practice.
We walk through the full intake-to-submission workflow with your team. No slides, no sales pitch — just the platform and your actual use case.
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