If you produce, handle, or study drugs at your company, pharmacovigilance is very important. If you're worried about drug safety issues relevant to your organization, a pharmacovigilance consulting company may be able to help you in the following three areas of concern.
1. Fact-Based Methods
One of the most basic questions that have to be addressed in pharmacovigilance is "How valid are these claims?" If a business has to shut down production, it wants to have a reasonable level of confidence that doing so serves the public good. Patients who depend on particular drugs may not have quality substitutes, which means lives are or could be at risk.
Implementing fact-based methods entails doing work in several areas. First, there is the basic idea of traditional scientific methods and how they'll be applied to testing. Second, the rise of Big Data system means that collection and analysis of data often exceed the know-how available at some operations. A pharmacovigilance consulting firm can help you make choices about how to collect and analyze data, right down to decisions about equipment, software, logging practices, and the people who'll use these systems.
2. Independent Input
Even in an organization with a sterling ethical record, biases come into play. There is no substitute for unbiased opinions about processes, especially in a field with the stakes of pharmacovigilance. Business decisions need to be cleanly separated from how a company evaluates safety risks, relays data, implements ethical standards and balances benefits against adverse effects. Similarly, a pharmacovigilance consulting company can provide you with insights about how these concerns out to be addressed in different regulatory environments, such as the E.U. versus the U.S.
3. Developing Processes
Just as important as the methods and legalities are the processes and the questions attached to them. How will you ensure, for example, that vital data is secured in a manner compliant with medical privacy laws and established ethical standards? What processes can be implemented to ensure that data gets to key decision-makers as fast as possible? How will the continued refinement of risk evaluation be implemented?
A pharmacovigilance consulting partner can help you look at your existing processes to identify areas where legal and ethical problems might emerge. Likewise, you can explore how to make processes more efficient and effective. Eventually, the answers to all these questions will need to be compressed into a set of standard operating procedures that can be published in a manual your teams will use.
