A fully functioning pharmacovigilance program is essential in any clinical study for a drug, biologic or medical device. If you don’t take the time to monitor, assess, and manage adverse reactions, you risk potentially devastating economic consequences or worse; endangering participants and potential end users of the product.
While Pharmacovigilance is absolutely necessary, it’s also costly. Navigating the complex regulatory requirements for drug safety is challenging for even the largest pharmaceutical companies. But for small and medium-sized companies, these challenges can be difficult to overcome.
Since most startups and smaller operations may not be ready to build their own in-house pharmacovigilance teams, it often makes financial sense to outsource their PV needs. Hiring a pharmacovigilance vendor can provide a multitude of benefits for your team, ranging from economic efficiency and access to expertise to ensuring regulatory compliance and patient safety. See below for a few of the key benefits of outsourcing your pharmacovigilance needs to a qualified vendor:
Benefit #1: Enhanced focus on core competencies
Outsourcing pharmacovigilance frees up time so your team can focus on their specific area of expertise. Instead of spending time writing regulatory reports and submitting applications to regulatory agencies, your team can maintain their focus on research and development.
Benefit #2: Maintain regulatory compliance
Regulatory standards are constantly evolving, which is one of the main reasons pharmacovigilance is so nuanced and can be costly. A pharmacovigilance vendor streamlines this process through robust safety reporting and monitoring. All data is stored and managed in a single, secure location ensuring you stay in compliance with industry guidelines.
Benefit #3: Increased cost efficiency
Outsourcing pharmacovigilance reduces your operational costs through fractional employment. Rather than staffing an entire pharmacovigilance department, it provides access to specialized expertise when you need it most.
What’s more, a dedicated pharmacovigilance vendor has in-depth knowledge of safety regulations, adverse event reporting, and risk management. For many biotech companies, these invaluable insights are well worth the investment.
The Importance of Choosing the Right Pharmacovigilance Partner
While there are various companies that provide outsourced pharmacovigilance services, it is important to choose the right vendor carefully to ensure your study’s specialized needs are met.
Here are some key things to consider before selecting a pharmacovigilance partner:
Regulatory Compliance and Expertise
An experienced pharmacovigilance vendor has a thorough understanding of global pharmacovigilance guidelines, including ICH E2E, FDA regulations, EMA requirements and more. They should also know how to handle adverse event data, signal detection, risk assessment, and regulatory reporting.
Technology and Infrastructure
Evaluate each potential vendor’s technology infrastructure, including its adverse event database, signal detection tools, reporting systems and data security measures. Any organization that you consider should have technology that aligns with industry standards and provides data confidentiality.
It can be particularly beneficial to work with a pharmacovigilance provider that uses a single database, such as Argus. This prevents the siloization of complex data sets, ensuring easier monitoring and compliance.
Flexibility and Scalability
Many biopharmas’ pharmacovigilance needs evolve over time. As your clinical development programs grow, monitoring their safety and associated regulatory requirements becomes even more complex. Therefore, it’s crucial your pharmacovigilance vendor is able to scale their services as your product lineup expands. Before making a final decision, consider your company’s future. How much do you plan on growing and changing in the next two, five, or ten years?
Quality and Processes
Successful pharmacovigilance programs follow established quality management systems. When investigating potential partners, make sure to ask about their standard operating procedures as well as their approach to maintaining data accuracy and integrity.
Communication and Collaboration
Successful outsourcing of your pharmacovigilance needs requires open collaboration and effective communication, like any successful relationship. If a potential partner doesn’t have systems in place for regular reporting mechanisms, this can be problematic.
Any pharmacovigilance vendor worthy of their stripes uses specific communication channels, stays in touch throughout all aspects of the regulatory process, and willingly collaborates with your internal teams.
Cost and Value
Working with a pharmacovigilance vendor is an investment, but it’s worth every penny. Consider that the impact and management of adverse drug reactions cost up to $30 billion annually!
As a business owner, cost is always a consideration, but it shouldn’t be the deciding factor. Instead, focus on the potential value that the pharmacovigilance vendor will bring to your clinical operation. Consider their expertise, the services they offer, and their ability to contribute to your study’s pharmacovigilance goals.
Selecting the Right Pharmacovigilance Vendor – The Bottom Line
The complex and highly technical world of pharmaceutical regulations can be overwhelming, especially considering the potential risks of not adhering to these guidelines.
Partnering with an experienced pharmacovigilance vendor can take some of this Sisyphean weight off your shoulders. However, it’s a strategic decision that requires time and careful consideration. Don’t rush the process. Conduct thorough due diligence, involve your leadership team, and select a vendor that aligns with your company’s goals and values.
With dedication and effort, you can find a valuable pharmacovigilance partner who lets you focus on your core competencies, helps you maintain regulatory compliance, and streamlines cost-efficiency.
Thinking About Working with a Pharmacovigilance Vendor? Get In Touch!
At Harbor Clinical, we have years of experience acting as an outsourced pharmacovigilance vendor. Our unique “functional, flexible, fractional approach” is specifically designed to scale with you.
As a contract research organization, we understand the complex and ever-changing nature of global pharmaceutical regulations. Our pharmacovigilance experts are the best in the field and can assist whenever you need them most.
Furthermore, we’re committed to data efficiency. Harbor Clinical uses one managed database to store and monitor all safety data across multiple studies, mitigating the siloization of data and interoperability.
Have questions? We’d love to answer them! Call (781) 775-0342, send a message to [email protected], or click here and fill out a digital contact form. We look forward to hearing from you.