## **Control Safety Data at the Source, at Any Scale**

Improve data quality and speed with source‑driven adverse event capture.

#### **The Challenge for Pharma**

Mid‑to‑large pharmaceutical companies, particularly those with combination product portfolios, blockbuster products and extensive patient support programmes, face a fundamental challenge capturing data about adverse events and product issues.

Traditional workflows rely on paper documents, emails and manual data entry that introduce delays, errors and incomplete information.

Companies face a choice between hiring more staff or accepting growing backlogs with regulatory risk, while follow‑up attempts succeed only 10 percent of the time.

## **Supporting Scale Without Compromising Safety**

The rapid growth of GLP 1 therapies and high-volume generic portfolios has fundamentally changed the safety landscape. Suppliers now face intense pressure to support multiple markets, partners, and patient support programmes while maintaining consistent, regulator-ready data quality at scale.

For manufacturers of generics, GLP 1 therapies and combination products including inhalers, patches, glucose monitors and specialist treatments; the core challenge is not demand but control.

Extremely high report volumes are driven by chronic use and very large patient populations. Reporting originates from many sources including healthcare professionals, patients, patient support programmes and partners. Fragmented intake channels create duplication, reconciliation effort, and delays. Limited standardization reduces visibility and consistency across affiliates, licensees, and distributors.

#### **The Hidden Cost of Inhouse Solutions. Is Your Safety Infrastructure Keeping Up with Reality?**

Many organizations still rely on internally built or heavily customized pharmacovigilance intake solutions. Most were designed years ago for lower volumes, simpler portfolios, and less demanding regulatory expectations. What once seemed practical and cost effective can quickly become a constraint.

Key questions organizations should ask include:

- Can your in-house solution adapt fast enough as global regulatory requirements continue to evolve
- Who owns system upgrades, validation and change control and how often are these delayed
- Can your intake workflows scale quickly to handle sudden volume spikes from blockbuster or GLP-1 products
- How much effort is spent chasing missing, inconsistent or unusable reports
- Are scarce pharmacovigilance and IT resources tied up maintaining systems rather than delivering value

Maintaining pharmacovigilance intake internally often introduces hidden costs. These include slower innovation, growing technical debt, high reconciliation effort, and increased compliance exposure.

## **Why This Is Needed Now**

Most companies still depend on workflows built for a paper‑based world, leaving affiliate teams overwhelmed as blockbuster and mega‑blockbuster products surge in volume.

Drivers include:

- Volume growth
- Patient self‑administration
- Combination product proliferation
- Direct‑from‑source reporting
- Patient support program complexity
- Low follow‑up success
- Regulatory expectations for data quality

Affiliate teams face overwhelming workloads, from heavy reconciliation and self‑administration complexity to incomplete reports and chaotic patient‑support data. Confusing combination‑product routing, manual entry bottlenecks, and underestimated intake‑design complexity further slow operations.

# **The Impact of Doing Nothing**

Poor data capture at source creates cascading problems: workflow collapse, impossible hiring requirements, backlogs, wasted follow‑up, transcription errors, routing delays, limited safety insight and compromised regulatory compliance.

## **The Power of a Purpose-Built Solution**

### **Product Foundations**

**Purpose‑built for source capture**, Reportum is fully **mobile‑responsive** and **persona‑specific**, designed to deliver the right experience for every reporter.

Backed by **10+ years of production use**, it operates globally at scale — with **over 2 million reports** collected across **110+ countries** and supported by **125+ PSP vendors**.

Our combined **pharmacovigilance specialists** and **UX experts** ensure reliable, high‑quality data capture that works seamlessly in real‑world environments.

### **Proven Impact & Integration**

Reportum delivers measurable results for pharma and medical device organisations, including:

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

It also integrates effortlessly with major safety and enterprise systems, Argus, ARISg, Veeva Safety, CRM, EDC and API/FTP, while supporting PSP excellence, combination‑product routing, and AI‑enabled workflows.