Drug Safety Databases – Essential Features

Pharmacovigilance has grown significantly in recent years and thus creates the need for a highly efficient Pharmacovigilance (PV) database essential for all the Pharma, Biotech, and Clinical Research Organizations.

To obtain this kind of productivity and efficiency, you must keep in mind some of the essential features which a PV system should comprise.

1. The Must-Have Basic Features – Below are some essential features that a pharmacovigilance database should have:

• The system should have the ability to report adverse events via configurable web form over secured internet.
• Custom validation should be present to ensure data consistency & completeness of cases.
• ICSRs – R2 & R3 compliance.
• Periodic Reports (like NDA, PADER, PSUR, etc.) and Line listings must be present.
• Must have an automated configuration for listedness.
• Auto narratives.
• Should support medical devices, clinical studies, spontaneous, literature cases, etc.
• MedDRA and WHO Drug dictionary integration
• The system should have more configurations and less customizations
• Must have an in-built AS2 gateway for regulatory e-submissions.

2. User Friendly and Easy-to-Use – When a company adopts a new technology, sometimes it makes a mistake of neglecting the usability or the user friendliness. It is critical to address this for the success of high-performing PV business. This should never be overlooked.

3. Configurable to meet sponsor SOPs – The timelines of submission differ for each regulatory agency and sponsors. The SOPs differs from sponsor to sponsor. A PV database should be dynamic enough to be confirmed to address all the changing regulatory and sponsor needs with configurations. The system should not make the sponsor to change his SOP according to the system, but the system should be capable of meeting sponsor SOP and timelines.

4. Automated Case Tracking / Monitoring Case Submission Timelines – Meeting timelines of the regulatory is a crucial task in Pharmacovigilance. When the number of cases increases, it becomes hard for the CROs/ Pharma companies to track every case to ensure it is processed and submitted to agencies on time.

5. Regulatory Compliance and Inspection Ready – The system should maintain an audit trail for every operation. It should have fully-compliant eSignatures for all stakeholders. Pharmacovigilance database should comply with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GDPR, GxP, GAMP5 guidelines, etc.

6. Should be Cost-Effective – Pharmacovigilance is an expense for any company. Some Pharma/CROs are on the verge of saving costs, they cut the costs on the teams they hire, and they spend a lot on procuring traditional Pharmacovigilance databases. This strategy is completely wrong. Just an expensive PV system cannot meet all the regulatory guidelines without a strong team in place.

8. AI & Automation – The future is going to be Automation and AI. There are a lot of advancements going on in Pharmacovigilance using Automation and AI. Though there are no solid proven AI capabilities in the PV, the Pharmacovigilance database should have AI and Automation capabilities with which some of the processes like Literature Screening, Social media searches etc. can be automated. The system should be mandatorily built with the framework with supports AI and Automations.

9. Multilingual CapabilitiesFor countries like Japan and China, new rules for Pharmacovigilance are on the way. CROs, Biotech and Pharma companies from these countries will soon be required to submit their regulatory reports in their national languages by the end of 2020.

10. Signal Detection – As manual signal detection processes consume considerable time, PV team might require a few weeks to analyse a signal. The system should have an in-built signal detection feature as the PV team require focusing on real-time issues while reducing the time and effort spent in determining the fake signals. Hence it is important that the PV database supports signal detection.