Safety Database

Safety Database has a crucial place in today’s pharmaceutical industry. Patient safety is the prime and most important goal for pharmaceutical companies across the globe. With Safety Database, we will get one step closer to that. The Safety Database acts as a repository for the Individual Case Study Reports (ICSRs) of the company’s products. It makes it easy to report and aggregate the safety data to third parties and the authorities. Along with that, these reports will also provide key information for the ongoing safety signals detection and risk-benefit evaluation of a particular product. All these reasons make it highly vital to make sure that the safety database of Pharmacovigilance is up-to-date according to the latest reporting requirements to meet the needs of regulatory compliance.

We at Vizen Life Sciences understand the need for a safety database, so we offer our clients an effective and accurate safety database solution that meets their expectations. From the maintenance cost to compatibility, there are many things that clients find difficult, but with our Safety Database services, you can rest assured that you are in safe hands. An in-house safety database solution can cost your organization tons of money for both implementation and maintenance. However, we at Vizen offer a completely managed and maintained safety database solution that is both cost-effective and maintains compliance according to the ever-changing regulatory requirements.

Our Safety database solution is a highly scalable, integrated, end-to-end safety platform that supports a global safety database. Our clients can leverage this solution to gain a complete view of their compliance and reporting metrics. The clients can make more informed decisions with the analytics and the actionable insights, not only that, but the users can also improve their case review speed and integrate the solution with other systems. We have expertise in various PV safety Databases such as Argus, Aris Global IRT, Clinenovo, Safety Base Interchange, and ARISg/LifeSphere Safety.

Why Vizen Life Sciences?

We have always believed in designing a solution that makes Pharmacovigilance simple and straightforward. We understand that complex databases with a myriad of functionalities will only end up confusing our clients. We understand our client’s requirements and then add the functionalities to the tailored solution to meet their needs. Our team of PV experts has been provided the user-end training and is highly experienced in utilizing the solution to its full potential. We always strive to help our customers in all their endeavors, from risk-benefit analysis of the product to its marketing, we are with you at every step of your journey.

Our solution complies with all the emerging and current regulations including 21 CFR Part 11, GxP, ANNEX 11, and GDPR. Our safety database services include hosting, implementation, servers, maintenance, upgradation, and support. The Vizen safety database is maintained in accordance with the change management procedures along with WHO DD updates, MedDRA recording, upgrades, and patches to ensure that your database is always up to regulatory compliance.