Pharmacovigilance has always been a crucial component of the biopharmaceutical industry, but it has become even more so over the last decade. During that time, regulatory authorities developed enhanced safety documentation protocols and increased warnings and awareness about drug-specific risks and adverse reactions.

This focus on transparency and clinical compliance is exciting. It promises a brighter, safer future, but there are also associated considerations for any sponsor. For instance, many biopharmas are forced to spend hundreds of millions of dollars to build the necessary infrastructure to maintain pharmacovigilance activities in-house. However, without adequate funding, it can be difficult if not impossible, to scale up compliance efforts, much less keep qualified people on staff to perform necessary pharmacovigilance functions. 

It is crucial that you properly document the necessary safety data. It’s vital to detecting, assessing, understanding, and preventing adverse events. That said, you don’t have to collect and analyze all that information on your own. Outsourcing your pharmacovigilance needs can provide peace of mind, keep your timeline on track and contribute to overall safer healthcare practices. 

3 Benefits of Outsourcing Pharmacovigilance Services

Let’s take a closer look at the benefits of outsourcing your pharmacovigilance tasks:

1) Enhanced Data Accessibility & Efficiency

Many biopharmas use multiple software programs to store and analyze safety data, which means you may have crucial patient insights spread across three or more computer hard drives.  This lack of centralized information can cause major headaches and delays, especially in the event of an audit or investigation. 

Outsourcing your pharmacovigilance activities streamlines the process. Specifically, it allows you to keep all of your safety data in one place across multiple studies. What’s more, it makes data retrieval processes more efficient and mitigates the challenges associated with incompatible data management systems. Considering all of the privacy regulations currently in place (more on that below), outsourcing some of this responsibility can take a huge weight off your shoulders.

2) Cohesive Reporting & Regulatory Compliance

The pharmaceutical regulatory landscape is complex, confusing, and constantly changing. Rules and regulations are added, updated, and removed each year. While it is difficult to stay up to date, you cannot afford not to.  Breaking even minor regulations can result in serious fines, penalties, and investigations. And remember: as your business grows, so does the complexity of your pharmacovigilance efforts. 

By outsourcing these responsibilities to a qualified provider, you can ensure compliance with industry standards and current regulations. Not to mention, it can help you build stronger relationships with regulatory authorities and simplify audits and investigations, if and when they arise.

3) Comprehensive Safety Analysis and Risk Management

Beyond the risk to human subjects, Adverse Drug Reactions (ADRs) can be incredibly expensive and significantly impact the bottom line of your budget. In the United States alone, ADRs  cost up to $30.1 billion annually due to increased hospitalization, prolongation of hospital stays, and the need for additional clinical investigations. Notably, many of these risks and associated costs could be reduced or avoided with improved safety analysis and risk management during the drug development process. Admittedly, it can be challenging to carry out these activities on your own, particularly if you don’t have the internal bandwidth or budget.  

Here too, outsourcing pharmacovigilance activities makes a lot of sense. Companies that specialize in collecting and analyzing patient safety data follow stringent quality control measures and risk management protocols. This focus on quality assurance helps protect data integrity and reduces the risk of common problems like adverse reactions and non-compliance.

At Harbor Clinical, our pharmacovigilance services include:

• Integrated risk evaluation
• Proactive risk mitigation strategies
• Collecting adverse drug reaction data and information
• Creating and submitting expedited and aggregate pharmacovigilance reports
• Assisting with internal and external compliance reports
• Performing trend analyses and predictive modeling for compliance operations

Outsourcing your pharmacovigilance needs provides the added benefit of savings, too. A Deloitte Global Outsourcing and Insourcing Survey found that companies that elect to outsource at least some of their activities experience a cost savings of more than 10% on average.

The Benefits of Centralized Pharmacovigilance Data – The Bottom Line

Establishing a drug safety profile is perhaps the most important aspect of drug development. Yet it’s rarely treated as such. Far too often, biopharmas put pharmacovigilance activities on the back burner, or worse, create a mishmash of storage systems, leaving private patient data to languish in disparate silos. There’s a better way and it starts with outsourcing. 

At Harbor Clinical we provide centralized pharmacovigilance management that makes it easy to keep all of your important safety data in one place. Our subject matter experts are familiar with current data storage rules and regulations and can help bring your pharmacovigilance system into the 21st Century. 

Whether you’re an established biopharma with decades of drug development experience or a startup looking to build a strong pharmacovigilance foundation, we’re confident we can help.  To learn more about our pharmacovigilance capabilities, get in touch. Call (781) 775–0342 or send an email to [email protected].