After a Sponsor obtains a marketing authorisation, the drug development cycle is not over. Now is the time for the ongoing tasks related to pharmacovigilance: that is, the functions associated with detecting and assessing any adverse effects caused by pharmaceutical products and establishing the best way to prevent them.
Why Outsource Pharmacovigilance?
Pharmacovigilance activities predate the advent of modern medicine when physicians first began to look for possible risks attached to chloroform anaesthetics. However, in the 1960s, pharmacovigilance became a more regulated and mandatory stage, tightly defined by regulatory agencies1.
Over the past decades, the pharmaceutical industry has gained the ability to share and analyse data more quickly worldwide. This has provided more efficient ways to carry out pharmacovigilance activities, but it has also increased the pressure for compliance.
Smaller biopharmaceutical companies may no longer be economically feasible to handle their pharmacovigilance programs with in-house personnel. As a result, many companies now prefer to outsource them to a separate pharmacovigilance CRO.
Critical Trends in Pharmacovigilance Outsourcing
Over the past ten years, the drive towards pharmacovigilance outsourcing has been fueled by three key trends2.
The growing complexity of requirements
National and regional regulatory agencies, such as the Food and Drug Administration or the European Medicines Agency, usually require mandatory reporting of any adverse events that could be linked to a specific drug.
Before being investigated, these cases need to be appropriately documented and tracked. Safety questionnaires are growing longer and more thorough.
The emerging importance of cloud-based databases
Much of the data used for pharmacovigilance are reported using different mechanisms. Other events may appear as case studies in the medical literature. Now that electronic medical records have become the standard worldwide, many cloud-based monitoring services offer an opportunity to capture and contrast this data more efficiently.
Increased public awareness and transparency requirements
Whether through online patient support groups, traditional media, and informal forums, patients are now much more informed about the possibility of adverse drug reactions. As this topic has been pushed to the forefront of many citizens’ minds, regulatory agencies now also face louder calls into action.
As a result, pharmacovigilance is now a priority for regulators, industry leaders and the average public. There is an expectation that all data will be handled transparently and that public responses should be immediate. This may come at odds with traditional processes to verify or review possible adverse events.
Choosing a Partner for Pharmacovigilance Outsourcing
Hand in hand with requirements, the market for CROs that specialise in providing pharmacovigilance services has also expanded. Sponsors who are seeking to partner with an external organisation should look at the following:
- Whether the CRO will assign a dedicated team to their project or a primary contact who can communicate quickly and promptly.
- Whether the CRO’s in-house team keeps up to date with industry trends or regulatory overhauls.
- Whether they can show how they change their practices in response to these changes.
- Whether they are exacting in their record keeping.
Pharmacovigilance activities are now an ongoing task for drug manufacturers and researchers. To monitor any possible adverse events, it is often necessary to control different sources simultaneously and react quickly to new developments.
A good pharmacology CRO should have a thorough knowledge of what’s required and of current best practices. They should also be able to leverage cloud-based software tools to handle data more efficiently.