RxVigil

RxCloud Accelerator

RxVigil — ICSR Safety Database
for Every Clinical Trial Phase

Simplify ICSR case processing and safety reporting from Phase I through Phase IV. RxVigil brings case intake, coding, review, and E2B submission into one connected platform, so your safety team can work with clarity and report with confidence.

Simpler Case Processing  •  Cleaner Safety Data  •  On-Time Reporting

Phase I to Phase IV in one database MedDRA & WHODrug coding built in Role-based access & full audit trail Backed by hands-on PV experts
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What is RxVigil?

RxVigil is RxCloud's safety database for Individual Case Safety Reports (ICSRs). It helps Life Sciences organizations capture, process, review, and submit safety cases within one connected platform, supporting pharmacovigilance across every phase of clinical development — from Phase I through Phase IV and post-marketing. Built around the practical needs of safety teams, RxVigil covers the full case lifecycle, from initial intake to E2B file generation. It delivers the essential capabilities you need, and nothing you don't.

One
Platform from Intake to E2B Submission
Phase I–IV
Consistent Safety Data as Your Product Advances
Fewer
Clicks per Case and Less Training
Inspection-Ready
Audit Trails and Controlled Access

The Safety Case Management Challenge

Costly legacy databasesLarge safety suites bundle modules teams rarely use, along with heavy infrastructure and long upgrade cycles.
System changes as products advanceSwitching databases between early-phase and later-phase studies fragments safety data and adds rework.
Complex, click-heavy workflowsCrowded screens slow case processing and lengthen training for new team members.
Limited visibility across studiesWithout clear status and deadline views, reporting timelines are harder to protect across trials and partners.
Patient medication safety – RxVigil ICSR safety database for clinical trial pharmacovigilance

What RxVigil Delivers

  • One home for every case: ICSRs from all trial phases and post-marketing sources, managed in one place.
  • Cleaner data, earlier: Quality checks flag missing or inconsistent information before a case is completed.
  • Faster, simpler processing: Intuitive workflows organized around the tasks safety teams perform most.
  • Confident, on-time reporting: E2B-ready output and deadline views by study and product.
  • Inspection-ready by design: Role-based access and audit trails preserve traceability at every step.

Built for Every Stage of Your Safety Journey

First-in-Human Studies

Stand up a right-sized safety database quickly for your first clinical trial.

Multi-Phase Trial Portfolios

Run multiple trials across phases on one consistent safety platform.

Outsourced Safety Operations

Gain clear oversight of case status and workload when safety work is shared with partners.

Legacy Database Replacement

Move away from a costly legacy system with migration planning and validation support.

Core Safety Database Capabilities

Centralized Case Management

Capture and manage ICSRs from Phase I to Phase IV clinical trials and post-marketing sources in one place.

Structured Safety Data Capture

Organize study, patient, reporter, product, adverse event, and medical history data, with built-in MedDRA and WHODrug coding.

Case Processing & Review Workflows

Follow defined steps for data entry, quality review, medical assessment, narrative authoring, and case completion.

E2B File Generation & Submission

Prepare structured safety data for electronic exchange with health authorities and partners, aligned to regional requirements.

Data Quality Checks

Identify missing or inconsistent information before a case is completed.

Follow-up & Duplicate Management

Manage case updates and identify potential duplicate reports with ease.

Controlled Access & Traceability

Role-based permissions and audit trails support accountable, inspection-ready data handling.

Operational Visibility

Track case status, workload, and reporting deadlines by study and product.

How RxVigil Works

01

Intake

Capture new cases and follow-ups from clinical trial and post-marketing sources.

02

Process

Enter structured data, code with MedDRA and WHODrug, and resolve quality checks.

03

Review

Complete quality review, medical assessment, and narrative authoring.

04

Submit

Generate E2B files and track every report against its deadline.

Why RxVigil Over Traditional Safety Databases

  • Purpose-built for ICSRs: A focused case processing and submission engine, not a bundle of modules you pay for and rarely use.
  • One database for every trial phase: Consistent safety data from early-phase studies through Phase IV, with no system change as your product advances.
  • Designed around PV practice: Shaped by RxCloud's hands-on experience in case processing and safety operations.
  • Focused on everyday usability: Essential functions organized around the tasks safety teams perform most, with less training and fewer clicks per case.
  • Right-sized cost & effort: A lean platform without the heavy infrastructure, long implementation cycles, and upgrade burden of legacy systems.
  • Implementation aligned to your needs: Configuration, migration planning, and validation support scoped to your organization's requirements.
Safety case status and reporting deadline dashboard – RxVigil operational visibility
RxCloud pharmacovigilance specialists supporting RxVigil implementation and training

Why Choose RxCloud for Safety Case Management

RxCloud pairs software with pharmacovigilance expertise, so you work with one partner from setup to steady state.

Technology with Domain Support

RxVigil is backed by PV specialists who provide training and implementation guidance alongside the platform. Explore our full Pharmacovigilance Services.

Life Sciences Compliance Experts

RxCloud's experience in GxP audits, including GVP, and computer system validation supports a compliant, well-governed rollout.

Frequently Asked Questions – RxVigil

RxVigil is RxCloud's safety database for capturing, processing, reviewing, and submitting Individual Case Safety Reports (ICSRs) in one connected platform.
RxVigil supports every phase from Phase I through Phase IV, plus post-marketing sources, so your safety data stays in one system as your product advances.
Yes. RxVigil captures structured study, patient, reporter, product, adverse event, and medical history data with MedDRA and WHODrug coding.
Yes. RxVigil prepares structured safety data as E2B files for electronic exchange with health authorities and partners, aligned to regional requirements.
Role-based permissions and audit trails make every action on a case traceable and accountable.
Yes. RxCloud provides configuration, migration planning, and validation support scoped to your organization's requirements.
Contact RxCloud to discuss your requirements. We'll walk you through RxVigil and outline an implementation plan that fits your team.

Build a Simpler Foundation for Your Safety Operations

Connect with RxCloud to discuss your requirements and see how RxVigil can support your safety team, from your first case to your next submission.

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