7 essential questions to ask before choosing a safety reporting vendor

Choosing the right pharmacovigilance (PV) solution is crucial for ensuring compliance, efficiency, and data quality in safety reporting. A strong system not only helps meet regulatory requirements but also reduces the burden on safety teams through automation and seamless integration.

Here are seven key questions to ask your safety reporting provider – and what to expect from a best-in-class solution.

1. Do you offer readily available gateways to major regulatory agencies?

Why it matters:

Direct, seamless integration with global regulatory bodies like the FDA, EMA, and PMDA ensures timely and compliant submissions without manual file transfers or third-party intermediaries.

What to look out for:

You should expect your provider to have pre-configured regulatory gateways that support real-time submissions and acknowledgments, for all major regulatory agencies. Watch out for systems that require additional customizations or manual data uploads, as these can introduce errors and delays, and it will be burdensome for your team.

2. How does your system handle automated business rules and on-screen validation checks?

Why it matters:

Ensuring compliance with regulatory business rules before submission reduces errors, preventing costly rejections or queries from agencies.

What to look out for:

Seek a system with built-in automation that checks data against agency-specific rules in real time. If a provider lacks these automated checks or only offers them post-submission, your team may face unnecessary rework and submission challenges.

3. Does your system provide direct feedback from regulatory agencies?

Why it matters:

Timely feedback helps pharmacovigilance teams quickly address and resolve any submission issues, reducing delays in regulatory reporting.

What to look out for:

The best solutions automatically receive and display regulatory responses within the platform. Be wary of systems that require manual tracking of submission statuses or provide limited visibility into agency feedback.

4. Can I send test files to ensure successful configuration before live reporting?

Why it matters:

Sending test files ensures that data mappings, configurations, and integrations work correctly before actual regulatory submissions, preventing re-work and errors.

What to look out for:

A reliable solution allows test file submissions to major agencies, verifying system functionality before real-world use. If a provider does not support test submissions, you may risk unexpected failures or rejections when live reporting begins.

5. What level of automation does the system include?

Why it matters:

Manual data entry increases the risk of human error and reduces efficiency. Automated data capture, import and validation improve accuracy while freeing up valuable time for safety teams.

What to look out for:

An effective system leverages automation to pre-fill fields, populates AE reports automatically from data imports, and applies business rules to improve data consistency. Be cautious of systems that rely heavily on manual input, as this can lead to errors and inefficiencies.

6. What does your implementation process look like?

Why it matters:

A lengthy, complex implementation process can be costly, delay regulatory compliance and disrupt operations. A system that is easy to deploy minimizes downtime and allows teams to focus on safety management rather than troubleshooting IT issues.

What to look out for:

The best solutions offer cloud-based deployment with clear documentation, training, and responsive support. Be cautious of systems that require extensive customization or prolonged setup times, as these will delay compliance and increase operational costs.

7. Is there a sandbox or test environment available?

Why it matters:

A sandbox environment allows teams to test the system, train users, and validate configurations without affecting live data, ensuring a smooth transition before going live.

What to look out for:

A well-designed system provides a dedicated test environment that mirrors the live system. Avoid providers that do not offer sandbox access, as this can lead to untested configurations and unforeseen issues during real-world use.

How cubeSAFETY stands out

When selecting a pharmacovigilance solution, you need a system that not only ensures compliance but also enhances efficiency and scalability. cubeSAFETY is designed to streamline safety reporting with industry-leading automation, seamless regulatory integration, and an intuitive user experience.

Regulatory Compliance Made Simple

• Pre-validated gateways for seamless submissions to FDA, EMA, PMDA, MFDS, and CDE

• Automated on-screen validation checks to prevent errors before submission

• Real-time regulatory feedback displayed directly within the platform

Advanced Automation to Reduce Manual Work

• Auto-populated fields and bulk data imports minimize human error

• Configurable business rules enforce consistency and compliance

• End-to-end tracking of submission status and agency responses

Seamless Implementation & User-Friendly Experience

• Cloud-based deployment for fast implementation with minimal IT burden

• Dedicated sandbox environment for testing and training before going live

• Scalable solution that grows with your pharmacovigilance needs

Unlike traditional systems that require manual uploads or extensive customizations, cubeSAFETY offers a fully integrated, out-of-the-box safety reporting solution that meets the highest industry standards.

Looking for a seamless safety reporting experience? Contact CRScube today to learn how cubeSAFETY can transform your pharmacovigilance operations.