From a pharmacovigilance (PV) viewpoint, what are some of the challenges Biopharmaceutical companies face in bringing new cost-effective medicines to market?
The PV sector has boomed in the last decade but this increase in demand has created a unique set of problems. Skilled resources are in great demand. The quality of new recruits and employees supporting PV services tends to dip while the quantity of work goes up.
This creates an unbalanced ratio of experienced to non-experienced team members. A byproduct of this unbalance is an increase in overtime hours and the establishment of unrealistic operational targets, increasing risks of error and turnover rates while reducing data quality and responsiveness.
Training programs have been established to meet resourcing needs. However, since many PV service providers created their own set of training programs, the industry lacks a standardized training approach across various service providers because their operational procedures vary from each other. These curriculums also may lack depth in many subject areas.
There is a silver lining to this situation. New industry-oriented courses are being activated every year by educational institutions who have started to acknowledge the potential of this untapped market.
How has Veranex adapted to meet these and other challenges?
At Veranex, our focus is to mitigate these challenges and provide a modern-day solution. Veranex has designed pharmacovigilance service delivery as part of a comprehensive package that overlooks a wider scope the entire clinical lifecycle, not a siloed, standalone offering.
Veranex supports clinical development in all phases, through post-marketing studies, with strategic services integrated into the process:
- Pharmacovigilance with clinical data management, medical writing and publishing, statistical programming and Biostatics, data visualization and functional sourcing
The Veranex Difference: Broad vision and deep expertise for your trial
Veranex has two decades of experience implementing industry-leading platforms that enable biopharmaceutical companies to better address their PV needs. A large team provides efficiency at a competitive cost while maintaining the highest standard in terms of quality and compliance and scalability to quickly support your development if needed.
“Quality Systems adopted at Veranex are a reflection of our Continuous Improvement Journey. The Quality Management Plan for each project helps us achieve better every time. Our risk-based approach to audits focuses on the areas of highest risk to our pharmacovigilance system. Regulatory intelligence, and top-up trainings promotes Compliance with all applicable GXP and a proactive approach combined with data-driven controls act as enablers of high expectations and quality” – PV QA: Veranex
Veranex leverages proprietary tracking and visualization tools that we developed specifically to manage deeper insight, rigorous quality, and compliance. We are a global company with multinational strategic locations, providing regulatory expertise across global markets and a diverse team of subject matter experts (SMEs) with an excellent resource acquisition process and ability to minimize turnover. The team understands the entire drug development process and brings an eye for detail to better coordinate with other functions. This team brings in an average 6+ years of strong expertise working collaboratively to seamlessly deliver per client needs.
What are important processes of the pharmacovigilance procedure?
Medical review is a critical aspect of the pharmacovigilance process. A data-centric approach to medical review helps to establish a causal link between adverse events and suspect pharmaceutical products.
“Vigilance especially in pharmaceutical industry is not just a job but a quintessential responsibility of every individual. Thus, to uphold quality in vigilance, is not the duty of few, but a moral obligation of all, to humanity.” – Medical Review Team: Veranex
Veranex uses a query-based vigilance approach in the overall assessment, where review is not confined only to retrospective analysis of patient data but also to predicting potential risks and identifying emerging trends. Our holistic service package assists you in maximizing trial and drug safety – from the identification of potential signals, to post-marketing risk identification and mitigation processes, to the generation of safety related documents. Ultimately, your Patient always comes first.
What PV Services are offered at Veranex?
Our Pharmacovigilance/ Device Vigilance Services include:
- Case Processing (Clinical and Post Marketing)
- Aggregate Reports
- Literature Screening
- Signal Detection
- QPPV Services
- Safety Database Hosting
- All other documentational Logistics
- Global PV audits