The pharmaceutical industry faces persistent challenges in Risk Based Quality Management (RBQM). Despite regulatory momentum and technological advances, many organizations remain risk-averse, favoring traditional processes over innovation. Siloed operations, incomplete integration of RBQM across the clinical study lifecycle, and late adoption of risk-based thinking continue to hinder efficiency and quality. Valuable data from previous studies is often underutilized, feedback loops are weak, and CROs are frequently treated as executors rather than strategic partners—limiting the industry’s ability to achieve operational excellence and regulatory compliance.

IQVIA’s Functional Service Partnership (FSP) model is designed to foster close collaboration with sponsors, enabling the co-creation of risk-based quality management (RBQM) strategies that are tailored to each organization’s unique needs. Rather than offering a one-size-fits-all solution, IQVIA works side-by-side with clinical, data, and quality teams to embed risk-based thinking throughout every stage of the study—from protocol design to closeout. This partnership approach encourages open communication, shared learning, and joint problem-solving, helping sponsors transition from reactive to proactive risk management. By leveraging advanced analytics and historical data together, we identify risks early and optimize site and CRA time in a way that reflects each sponsor’s specific goals and challenges. Our commitment to continuous improvement means that lessons learned are not only captured but collaboratively applied, driving ongoing process optimization and operational excellence that is truly individualized for every partner.

Through strategic technology partnerships and a human-centric approach, we position ourselves as a true partner in RBQM implementation. Experienced with a wide range of platforms, expertise in RBQM change management , and flexible, scalable delivery models enable sponsors to future-proof their operations and adapt to evolving industry standards. Our FSP teams provide dedicated support, rapid deployment of resources, and transparent communication, ensuring quality, business continuity, and improved outcomes across all phases of clinical development.

Clinical leaders across the pharmaceutical sector are invited to join this exclusive webinar to gain actionable insights into overcoming RBQM adoption barriers and unlocking the full potential of FSP partnerships. Featuring real-world case studies, expert panel discussions, and practical strategies, this session will empower you to drive innovation, enhance compliance, and deliver better patient.

Key takeaways:

• Overcoming RBQM Barriers: Identify the most common pain points and obstacles in Risk Based Quality Management adoption—such as siloed operations, late risk-based thinking, and underutilized data—and learn proven strategies to address them.
• Scalable, Client-Centric Solutions: Discover how IQVIA’s Functional Service Partnership (FSP) model delivers flexible, tailored RBQM solutions that adapt to your organization’s unique needs, enabling efficient scaling and improved outcomes.
• Integrating Risk-Based Thinking & Analytics: Learn practical approaches for embedding risk-based principles and advanced analytics into clinical operations, empowering teams to proactively manage risk and optimize study performance.
• Real-World Insights from Pharma Leaders: Gain valuable lessons from real-world case studies and partnerships with leading pharmaceutical companies, illustrating both the challenges and successes of RBQM implementation in FSP settings.
• Actionable Steps for Excellence: Leave the webinar with clear, actionable steps to empower your teams, enhance compliance, and drive operational excellence—ready to implement best practices in your own organization.

Speakers:

Debjit Chakrabarti, Senior Director, Head Centralized Monitoring FSP Services, IQVIA

Linda Philips, Senior Director, Centralized Monitoring, IQVIA

Joanne Benedict, Head of Risk Based Quality Management, Gilead Sciences