A conversation with Vikalp Khare, head of U.S. GPV safety data management at Otsuka, sheds light on the evolving landscape of pharmacovigilance (PV) and the technology choices that shape the industry. In a realm where patient safety, compliance, and scalability are critical, Khare’s insights challenge common assumptions about technology in large pharmaceutical companies versus smaller biotech firms.
Khare highlights that, contrary to popular belief, a big pharma’s technology suite is not automatically superior just by virtue of its size. Large organizations do possess mature pharmacovigilance systems, often comprising validated global safety databases and established protocols. However, these established systems may not always adapt well to new regulations and emerging technologies. Each study, trial, or product demands its own fresh evaluation, irrespective of the company’s size. The inclusion of novel therapies, decentralized data sources, and new regulatory expectations can often render existing systems inadequate.
On the flip side, smaller biotech firms, although they might initially lack infrastructure, often have the agility to innovate and re-engineer their PV processes without historical constraints. This flexibility can allow them to implement cutting-edge, automation-driven solutions more rapidly than their larger counterparts. Khare passionately argues that the effectiveness of PV technology must be assessed on its ability to ensure patient safety and compliance, rather than simply fitting a predetermined mold dictated by a company’s size or legacy.
The Landscape of PV Technology: Choosing Partners Wisely
When it comes to selecting PV technology, Khare emphasizes a thoughtful approach. While a few established players are prominent in the market, sticking to them exclusively may not always serve the best interests of a company. Rather than simply defaulting to the trusted vendors, it’s crucial to adopt a structured, risk-based view. Factors to assess include regulatory requirements, portfolio growth, integration capabilities, and overall total cost of ownership.
- Regulatory complexity: Navigating the intricacies of regulatory bodies like the FDA or EMA is crucial.
- Integration landscape: Strong integration with current safety systems and analytics tools is essential for cohesive operations.
- Inspection readiness: Ensuring that systems are prepared for regulatory scrutiny is paramount.
- Long-term cost considerations: Understanding the financial implications for the entire lifecycle of the technology is vital.
Khare’s philosophy revolves around the need for governance maturity, flexibility in configurations, and a partnership-oriented mindset with vendors. His balanced approach allows for leveraging robust, reliable systems while remaining open to innovative technologies that can enhance operational efficiency.
Leveraging Historical Knowledge: A Valuable Asset
Khare underscores the importance of a company’s historical knowledge when searching for PV technology. Past experiences, both successes and failures, provide context for making informed decisions about future technology selections. He recommends focusing on several key aspects:
- Upgrade and validation experiences: Analyzing past upgrades reveals valuable lessons on complexities and workflow inefficiencies.
- Global user feedback: Insights from those involved in daily operations can illuminate gaps in workflow.
- Integration history: Previous integration challenges inform future architectural decisions and help avoid redundant issues.
- Vendor performance history: The track record of vendor responsiveness during critical times is just as important as the functionalities they offer.
- Inspection and audit insights: Regulatory feedback shapes risk assessment and mitigation strategies.
By connecting the dots with historical knowledge, organizations can introduce innovations in a responsible and compliant manner, enhancing their overall safety management strategies.
Factors Triggering Reassessments of PV Technology
Khare believes that assumptions can often lead to oversights. In PV, what worked in a previous trial may not hold true in a new context. Several trial-specific factors he considers essential for reassessing PV technology include:
- Novel modalities: New therapies may introduce unique safety profiles, demanding recalibration of systems.
- Geographic considerations: Expanding to regions with different regulations can necessitate adjustments in systems and data handling.
- Design complexity: Adaptive and decentralized trials may require revisiting data flow and reconciliation processes.
- Scalability: High enrollment studies or larger global trials often require enhanced capacity and automation readiness.
- Portfolio scrutiny: Increased regulatory expectations for sensitive therapeutic areas can necessitate more robust systems to ensure compliance.
This structured, risk-focused approach ensures that technology in pharmacovigilance remains adaptable and compliant with the rapid advancements in the pharmaceutical landscape.
Timing of Technology Assessments
Khare advises organizations to start evaluating technology much earlier in the planning process than they typically do. As soon as there’s clarity on the clinical trial design and geographic scope, it becomes essential to assess the fitness of the existing PV ecosystem. Initiating this assessment during the finalization of the clinical development plan provides ample time for risk-based evaluations and necessary adjustments without creating last-minute compromises.
This proactive measure not only safeguards patient safety but also enables timely alignment with regulatory requirements, ensuring that organizations can confidently navigate the complexities of compliance.
Defining Non-Negotiables in the PV Tech Search
Through his experience, Khare has established key non-negotiables that resonate with every stakeholders in PV technology search:
- Regulatory compliance: Systems must unequivocally support global regulations and include necessary audit trails.
- Validation rigor: Strong vendor support for a defensible validation process is critical.
- Integration capability: Successful PV ecosystems require seamless integration with various clinical and regulatory platforms.
- Data governance: A sound data governance framework ensures compliance and security.
- Configuration flexibility: The technology must accommodate varied user needs while preventing excessive customization.
- Scalability and performance: Future-proofing the system to handle increased volume and complexity is indispensable.
In emphasizing these principles, Khare stresses that technology decisions in pharmacovigilance are fundamentally about enhancing patient safety and operational efficiency.
The Impact of Technology Choices on Outcomes
The decisions made during technology selection profoundly affect case quality, regulatory compliance, and scalability:
1. Case Quality: Efficient systems enable case processors to concentrate on medical assessments, minimizing the chances of errors introduced through poor workflows.
2. Regulatory Compliance: Systems must inherently support compliance, ensuring that robust audit readiness is achieved to avoid regulatory pitfalls.
3. Scalability: Future demands, swift case volume expansions, and transitioning from clinical studies to post-marketing phases require a well-thought-out scalability strategy.
Ultimately, every technological choice shapes the infrastructure that determines the integrity of patient safety and regulatory adherence in pharmacovigilance.
About The Author:
Vikalp Khare is a technology leader in global pharmacovigilance and safety data management, with extensive expertise in the Oracle Argus Safety Suite and large-scale data migration. He is responsible for overseeing compliant and efficient safety operations across international markets, bridging technology and pharmacovigilance to build intelligent, scalable systems that support patient safety and regulatory requirements.
