It can be easy to discount the need for robust pharmacovigilance (PV) systems and processes in the early phases of a clinical trial. However, these can become critical to safety and success in a post-market environment.
This leads many organisations to implement systems and processes on the run, making it expensive and leaving it open to errors and even costly audit findings. Here’s why it’s worth investing in the right PV solution from the outset.
Why is this happening?
In simple terms, at the start of potentially lengthy clinical trial periods, the need for a robust PV approach may be deemed non-essential, as the volumes of activity and reporting requirements are a lot less. In many cases, they can be easily managed with focused attention from an in-house regulatory SME and limited technology enablement, particularly as there is no requirement to log events onto the Global Safety Database.
As an example, selecting the clinical trial population correctly in relation to the drug or therapy should in most cases minimise the number of Adverse Events (AEs) being reported, as well as Serious Adverse Events (SAEs), and be adequately handled by simple technology (i.e., Excel, Access or other and a focused SME resource).
The trial primarily focuses on the efficacy of the treatment, and ongoing safety management is often an afterthought. However, if it’s not addressed early, it will hit the organisation like a freight train as the submission is made to proceed toward marketing authority approval.
In the post-market environment, safety reporting requirements are more than a”nice to have.” They are the law, with variations in different markets due to the individual nuances to regulatory requirements, such as US-FDA, UK-MHRA, EU-EMA, Japan-PMD Act, AUS-TGA, and guidelines as prescribed by the ICH.
Reporting of cases is only one of the many considerations an organisation must apply when transitioning from clinical trial to a market authorised drug deployment, and if the organisation is not a developed global drug corporation, it is unlikely to comply with the regulatory requirements.
Many organisations try to implement the full suite of PV safety elements at this point. However, it can be complex and takes time, so a rushed implementation can lead to a raft of negative results, including the potential for inspection audit findings that can be costly to your bottom line and your reputation.
A proactive approach controls costs and workload
A proactive PV Implementation is a LEAN implementation that will enable your corporation to keep control and reduce workload and costs at every stage.
The right solution involves a specific and co-ordinated effort across a range of areas, including:
- Organisational Design
Is the organisation adequately resourced to manage the ongoing PV requirements? Do you outsource or retain in-house AE, Aggregate, and Periodic reporting? Have you considered how to select suitable vendors and technologies? Is it future-proofed, or will the solution need revisiting?
- PV Process Design
Is the end-to-end process fully designed and appropriate for the task and signed off as such? Is the PV process manageable by the organization’s structure? Does the process tick all the boxes? For example, ICSR, Literature, Labelling, PSPs, Signal Detection, and Reporting Content? Is the PV process fully cross-functional to ensure efficiency and corporation-wide understanding?
- QMS Process Design
Are all of the required SOPs and WIs in place, and will they pass the audit inspection? Is the end-to-end QMS aligned to manage the PV process? Is the PSMF complete and audit-ready for all MAHs? If marketing in Europe, is the QPPV in place and trained?
- Technology Enablement
Have you selected the most efficient technologies? Is the Global Safety Database integration robust and compliant? Have you configured how to receive regulatory intelligence? Is the technology future-proofed and scalable?
- Training and Education?
Have all stakeholders been trained in the use of the technology? Have all the processes been trained out? What about vendors and partners? Have you considered enterprise-wide training requirements?
- Regulatory Authorities
Is your corporation ready for regulatory inspections? Are your report submissions in good order?
Tips to get your implementation right
- Be prepared to address the transition proactively with a detailed analysis of your current state through a formal gap assessment by PV specialists.
- Plan in detail the steps required to mitigate risk and eradicate the gaps.
- Implement the required steps in a controlled manner to avoid reactive firefighting behaviours that are costly and risky.
- Test your processes and systems before filing for inspection. A failure at this point puts the regulatory spotlight on your corporation and causes expensive re-work.
Seek expert assistance
When it comes to your PV systems and processes, a lot is at stake, from your reputation to patient safety. Therefore, it’s essential to partner with an expert who understands the operating and regulatory environment and has significant experience with best-practice implementation.
Explic8 assists life science organisations across the globe in all matters relating to PV and drug safety management. Our proven and cost-effective approach makes us the perfect partner in the safe delivery of new therapies.