Reportum® Platform

The market-leading unified safety intake platform that captures adverse events at source, strengthens workflow control, and helps pharmacovigilance teams manage reporting efficiently at scale.

As adverse event volumes and reporting channels grow, pharmacovigilance teams need a more connected way to capture safety data. Reportum is Qinecsa’s unified safety intake platform, capturing adverse events at source across digital and analogue channels. It standardises intake across global stakeholders, reduces manual effort, and improves data quality, helping life sciences organisations scale reporting operations while strengthening compliance, operational visibility, and patient safety.

What Is Reportum® And Why It Matters

Reportum is Qinecsa’s pharmacovigilance reporting solution designed to streamline the generation, management, and delivery of safety reports across global regulatory environments.

Safety reporting sits at the heart of pharmacovigilance. Organisations must generate periodic and aggregate reports such as PSURs, PBRERs, DSURs, and signal-related reports while ensuring they meet regional regulatory expectations. These processes often involve multiple stakeholders, large volumes of safety data, and complex timelines.

Without the right infrastructure, reporting can become fragmented, inefficient, and difficult to manage. Manual processes increase the likelihood of inconsistencies and delays, while disconnected systems make it harder to maintain oversight and control.

Reportum addresses these challenges by providing a structured, technology-enabled reporting framework that integrates data, processes, and expertise. The solution ensures that safety reports are produced accurately and efficiently while maintaining the traceability, governance, and quality expected by global regulators.

For pharmacovigilance leaders, this means greater visibility across reporting activities, improved operational control, and stronger compliance with regulatory requirements in markets such as the EU, UK, and US.

Key Features Of Our Reportum Solution

The Reportum platform incorporates several features designed specifically for pharmacovigilance reporting.

Structured reporting workflows

Reportum provides clear, repeatable workflows that guide safety reporting activities from data collection through to submission. This structured approach reduces the risk of delays or missed steps.

Integrated safety data access

The platform enables seamless access to safety data and reporting outputs, ensuring teams can quickly generate accurate reports without manual data consolidation.

Regulatory-aligned templates

Reportum includes templates and frameworks aligned with global pharmacovigilance regulations, supporting the preparation of reports required by authorities such as the EMA and FDA.

Centralised oversight and governance

Safety leaders gain visibility across all reporting activities, including timelines, responsibilities, and progress tracking. This improves operational control and inspection readiness.

Scalable delivery model

Whether supporting a single product or a global portfolio, Reportum scales with your organisation’s pharmacovigilance needs.

Quality and compliance controls

Built-in quality checks and governance mechanisms ensure that all reports meet regulatory expectations and internal standards before submission.

Together, these features ensure that safety reporting becomes a controlled, efficient, and reliable process rather than a reactive operational challenge.

Explore Reportum Insights

[Control Safety Data at the Source,

at Any Scale](https://reportum.qinecsa.com/unifiedsafetyintake/)

The rapid growth of GLP‑1 therapies and high‑volume generics is putting pressure on pharmacovigilance teams to scale across markets, partners, and patient programmes while maintaining consistent, regulator‑ready data.

Managing intake in-house often leads to hidden costs, including slower innovation, increasing technical debt, and higher compliance risk.

Reportum solves this by automating and standardising intake at scale, delivering:

• 60% reduction in central effort
• 45% reduction in local effort
• 95% reduction in reconciliation
• 40% fewer follow-ups
• $30–$50 savings per report
• 65% reduction in end-to-end workload

It integrates seamlessly with Argus, ArisGlobal, Veeva Safety, CRM, and EDC systems while enabling PSP excellence, combination product routing, and AI-driven workflows.

Safety Data Intake Solved

Traditional safety intake processes rely on emails, PDFs, and manual rekeying, leading to lost data, high effort, and low follow-up success rates.

This eBook shows how leading pharma companies are transforming intake by capturing structured data at the moment of reporting – where insight is richest.

What You’ll Learn:

• A proven 3-stage model for improving safety data intake.
• How to reduce case processing effort by up to 60%.
• Ways to improve data completeness and reduce follow-up.
• How to build a closed-loop, connected intake process.

Download eBook

Reportum AI - Modernise Adverse Event Intake Without Replacing Your Safety Stack

AI-assisted adverse event intake for global pharmacovigilance – built on Qinecsa’s proven Reportum platform, with human review and regulatory-grade governance at its core.

What you get:

• Up to 60% reduction in manual case processing effort
• Faster case availability and earlier signal visibility
• Multilingual extraction, translation, and structured digital follow-up
• Human review and regulatory-grade governance built-in
• Works with Argus, ArisGlobal, and Veeva Safety – no platform replacement

How Qinecsa Delivers Reportum

Qinecsa delivers Reportum through a combination of specialist pharmacovigilance expertise, advanced technology, and structured reporting processes.

Our team works closely with clients to understand their safety data landscape, regulatory obligations, and organisational structure. We then configure and implement the Reportum framework to align with their existing pharmacovigilance systems and operating model.

The delivery approach typically includes:

Assessment and planning

Qinecsa experts evaluate your current reporting processes, safety database outputs, and regulatory commitments to identify optimisation opportunities.

Implementation and integration

Reportum is configured to integrate with your safety systems, ensuring that safety data flows efficiently into the reporting process.

Process design and governance

We establish clear workflows, responsibilities, and quality controls to ensure reports are produced consistently and on time.

Operational delivery and support

Qinecsa teams support or manage reporting activities using Reportum, helping organisations scale their pharmacovigilance operations while maintaining compliance.

This integrated delivery model ensures that organisations not only implement a reporting platform but also embed best practice pharmacovigilance processes that support long-term operational success.

How Reportum Fits Into Your Wider PV Strategy

Effective pharmacovigilance requires more than isolated reporting activities. Reporting must be integrated into a broader safety ecosystem that includes case processing, signal detection, risk management, and regulatory compliance.

Reportum acts as a central component within this wider pharmacovigilance framework.

By providing structured reporting processes and centralised oversight, the platform connects safety data with regulatory outputs. This ensures that insights generated through case processing and signal management are translated into high-quality safety reports.

For organisations expanding into new markets or launching new products, Reportum provides a scalable reporting infrastructure that can adapt to evolving regulatory requirements.

It also supports inspection readiness by ensuring that all reporting activities are documented, traceable, and aligned with established pharmacovigilance procedures.

In practice, this means pharmacovigilance leaders can manage safety reporting with greater confidence while maintaining alignment with global regulatory expectations.