Choosing a safety database is a delicate operation that takes time. Every pharmaceutical company has its own specific needs. We have compiled for you a list of the main factors to consider when choosing a pharmacovigilance database.
Regulatory compliance. It may seem trivial, but the first thing to check in a safety database is compliance with pharmacovigilance regulations, compliance with the reference authority and compliance with the electronic format in force, currently XML ICH E2B (R3).
Implementation mode. A safety database can be available for purchase or in SaaS mode, a cloud database lease formula. Not all software houses offer the dual solution, therefore it is good to adopt the one most in line with the needs of the company.
How to submit ICSRs to the authorities. Cases can be submitted to the authorities by sending the ICSRs via email, but the most effective and immediate way is to use the Gateway. It is a program of massive transmission of data to the database of the authority, for example that of EMA, FDA and MHRA. This is the optimal solution for those with a large volume of cases to submit.
Parameterizable workflow. Every company has its own processes, which is why a good database needs to fit perfectly with internal procedures. Therefore, it should have a workflow that allows you to follow a flow in compliance with company pharmacovigilance procedures.
Security requirements. To comply with security requirements, the database must allow users to be parameterized with regulated access and permissions, to track all activities and to preserve data in line with data integrity and privacy requirements (GDPR).
Implementation time. A pharmacovigilance database can take some time to implement, especially if data migration from a previous database is required. Therefore, it is important to evaluate the compatibility of the timing proposed by the supplier with the needs of your company.
If you want to know more about the implementation time of SafetyDrugs, you can read more here: How long does it take to integrate SafetyDrugs into business processes?
Validation. The Computer System Validation of a safety database is an essential activity to comply with current regulations on pharmacovigilance. Make sure that the software house has already provided for the supply of all pre-validation documentation in line with GAMP5 and is available to support the entire validation process.
If you want to know more about the validation support of SafetyDrugs, you can read more here: Simple database validation with our help
Assistance. The assistance service provided directly by the developer software house is certainly more efficient, due to the greater knowledge of the product, the attentive care dedicated to its customers and the sensitivity in the timeliness of the response compared to an external management.
If you want to know more about the assistance service of SafetyDrugs, you can read more here: How the SafetyDrugs assistance service works
Maintenance. Being an IT tool that must comply with requirements and regulations, it needs constant maintenance to be kept up to date and compliant. Make sure the service is included in the fee.
Datacentre. A fundamental requirement of the data center where the database is installed is to have ISO 27001 certification relating to information security management. Furthermore, with the entry into force of the GDPR, it is essential that the data be stored within the borders of the European Union.
MedDRA dictionary. It is very useful for a database to have the MedDRA dictionary integrated and provided with a browser to speed up the search for the right term. As it is released updated twice a year by the authority, it is advantageous for the database to be able to bring updates online quickly.
Advantages. A database by nature must store, manage and extrapolate data. Therefore, evaluate that it has features to facilitate and speed up the activity of the pharmacovigilance team. Among the most useful features are:
- Preview the case first in order to confirm its import
- Automatic detection of duplicate cases
- Copy function to replicate the same contents in a new case
- Messaging and alert system for sending emails and notifications related to regulatory or process deadlines
- Case Agenda to record actions to be done and comments on the case, with the possibility of activating notifications
- Report for monitoring the activities performed in order to evaluate their performance
- Business Intelligence to carry out in-depth and immediate analyzes of aggregated data.