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Reportum

A platform managing adverse event reports globally, supporting multiple languages and devices, streamlining pharmacovigilance processes.

Solution by Qinecsa
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Overview

The Reportum platform is designed to manage adverse event reports from both digital and analogue sources across the globe, accommodating various languages. It provides an intuitive and engaging reporting experience that functions on users' preferred devices and in their local language.

Control Pharmacovigilance Workflow

Reportum ensures global consistency with a centralized, fully audit-trailed solution for all intake routes and follow-up processes.

Reduce Effort and Costs

By digitizing intake and output processes, Reportum streamlines pharmacovigilance operations, eliminating manual steps and reducing associated costs.

Fully Verified and Highly Scalable SaaS Platform

Digital and Pharmacovigilance Forms Intake

The platform captures data through a unified workflow engine, enabling digital intake at the source or automatic import of structured forms in multiple languages.

Configurable Platform

Reportum offers a tailored experience based on user type, product, and the nature of adverse events.

Seamless Integration

Automated E2BR2/R3 transfer into the safety database eliminates manual reconciliation efforts.

Scalable and Secure

With a high-performance cloud infrastructure, Reportum manages rapid changes in adverse event reporting efficiently.

Reportum PV Design Studio

Configurable Forms for Seamless Data Capture

The PV Design Studio allows for configurable forms tailored to specific business needs, including portfolio, therapy areas, and geographies, ensuring alignment with workflows. It captures data accurately from all sources, delivering it directly to the safety database.

  • Adverse Events (AE) & Product Complaints (PC)
  • Patient Support Programs, Market Research, Call Centers
  • Internal Staff, Sales, & Medical Representatives
  • Consumers & Public Reporting Channels

Why Choose Reportum PV Design Studio?

  • Configurable workflows for data capture from all sources
  • Extensive data capture for E2B or custom fields with seamless integration to downstream systems
  • Intelligent search and library support (MedDRA, UCUM, Product Library)
  • Multilanguage support for global scale
  • White labeling options

Expert Guidance & Support

Experts guide users from initial consultation to deployment, ensuring compliance and usability. The forms are designed to efficiently capture necessary data while adhering to regulatory standards.

Proof in Numbers

Reportum has processed numerous reports, working with program vendors and specialty pharmacies, achieving significant reductions in local and central case processing and reconciliation efforts.

Advancing Drug Safety Solutions to the Next Level

Reportum collaborates with life science companies to drive progress and enhance drug safety, continuing to protect lives.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & ComplianceClinical & Trials
Target user(s)
QA / Regulatory Affairs
Tag(s)
Quality & Compliance Management