Pharmacovigilance (PV) sits at the center of pre- and post-marketing drug safety efforts. Without it, the consequences to business and human life can be dire. This means the IT systems PV teams use to support their workflows are just as important. In this blog, we discuss how a trusted pharmacovigilance technology partner can help—and what to look for in a partner.
The World Health Organization (WHO) defines pharmacovigilance as the science and service of drug safety. Organizations perform PV activities to detect, assess, understand and prevent adverse side effects and other health-related problems from medicines and vaccines.
To track and report on adverse events in a compliant manner, pharmaceutical, biotech and medical device companies rely on PV and quality management software systems. For example, ARISg and Oracle Argus.
Like the rest of the life sciences industry, the pharmacovigilance function is highly regulated, which means it is critical that PV systems remain compliant at all times. However, due to the nature of most PV systems on the market today, maintaining PV systems is a time-consuming, expensive and complicated endeavor.
It can be very easy to get out of sync with a PV system configuration. So, it is imperative that you periodically take a deep dive into your configurations, processes and procedures to ensure everything is still up to date. That is, before regulatory authorities across the globe request a pharmacovigilance inspection.
The problem is complex, but the solution is simple. While you focus on important drug safety activities, work with a pharmacovigilance technology partner.
How to Choose a Pharmacovigilance Technology Partner
A pharmacovigilance technology partner can help life sciences firms maintain compliant and functioning PV systems. In addition, they can help you implement the right solutions and workflows for all your drug safety efforts. With pharmacovigilance consultants’ unique focus, you can avoid costly fines and lost business—or worse.
When choosing a PV technology partner, consider three main qualities:
#1. Experience with Leading PV Systems
The most important quality is that you find a knowledgeable PV technology partner who has deep domain experience and understands the industry inside and out. They should have hands-on experience in all leading PV software systems, whether cloud-based or on-premise, standard or enterprise.
This partner is, first and foremost, here to help you select, implement, integrate, migrate, audit and tune your PV platforms. In order to experience lasting business impact, you need a partner that can ideate realistic and sustainable technology strategies—and then help you effectively execute them.
With the right level of experience, your PV technology partner can also help you streamline adverse event reporting intake, workflows and case management.
#2. Focused on Compliance
When it comes to pharmacovigilance, compliance is critical. If your organization falls out of sync with incorrect or incomplete configuration of PV products, licenses, studies or reporting rules, you risk late submissions to regulatory authorities, non-compliance with contracts and quality-related issues during an inspection.
That’s why you need to choose a PV technology partner that takes compliance seriously.
The right partner will audit any cloud-based or on-premise systems for best practices and to ensure your systems are compliant with all relevant regulations and guidelines, like Title 21 CFR Part 11.
#3. End-to-End Support
You want a pharmacovigilance technology partner that can support highly scalable, end-to-end safety processes, with an emphasis on sustainable and actionable results—not just early-phase deliverables and presentations.
This means a partner that can be there for you throughout the entire project, from initial planning to implementation to business process optimization.
Here are different ways your PV technology partner should be able to support you:
- Perform a gap analysis of your PV processes and conduct a health check of your safety database
- Develop a well-articulated strategy and technology roadmap for continuous growth and improvement
- Help you migrate to a new PV system as a part of a new implementation project
- Integrate PV solutions with your complementary systems, like registration management and CTMS
Maintaining compliant PV technology solutions can be a difficult feat on your own. And, like the other areas of life sciences work, drug safety is not something you want to compromise on. Team up with an experienced pharmacovigilance technology partner to streamline safety operations, get the most of your PV investment and ensure patient safety.
Daelight Solutions partners with pharmaceutical, biotech and medical device companies to select, implement and maintain PV systems. Find out how we can help by contacting us today.