Industry Outlook: Benchmarking Biopharma’s Next Wave of Clinical Data Transformation
Webinars
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Navigating Trial Complexity with RBQM: Practical Strategies for Adopting Risk-Based Approaches
In this on-demand webinar, originally hosted in collaboration with SCDM, we discuss the case for elevating risk-based approaches to comply with regulatory guidance and streamline overall trial operations by illustrating both the incremental and cumulative impact of these practices.
Despite regulatory guidance asking trial sponsors to implement risk-based strategies, a recent industry survey indicated that only 13% of industry professionals see these approaches as a top focus for their organizations in the next 12 months. While trials continue to increase in complexity and regulatory guidance continues to evolve, efforts to embrace risk-based methodologies are often met with resistance across life sciences organizations. A survey of pharmaceutical, biotechnology and contract research organizations conducted by the Tufts Center for the Study of Drug Development revealed that the primary barriers to adopting risk-based approaches include lack of organizational knowledge and awareness, mixed perceptions of the value proposition of RBQM, and poor change management.
Drawing on use cases, we make the case for elevating risk-based approaches by illustrating both the incremental and cumulative impact of these practices to streamline overall trial operations and increase efficiency while complying with regulatory guidance. By sharing cross-trial insights, and highlighting the application of advanced methodologies, we aim to equip attendees with the knowledge and reference points needed to navigate the shift towards more effective and efficient risk-based approaches.
What You’ll Learn
- Understanding the evolving RBQM landscape and strategies for managing regulatory expectations
- Practical steps and actionable insights to inform RBQM adoption and address common challenges
- Critical alignment: Aligning people, process, and technology to enable adoption and unlock greater efficiency
- The incremental and cumulative impact of taking risk-based approaches on trial operations
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Presenters
Senior Director of Clinical Data Management, eClinical Solutions
Nicole is an accomplished clinical data leader, driving value and innovation in study management and development in the pharmaceutical industry, with over 25 years of experience in academic, sponsor, and technology company settings. Nicole has extensive global expertise in all aspects of leading data management and research solutions across a variety of therapeutic areas including oncology, cardiovascular, immunology, and neurology. As Senior Director of Clinical Data Management at eClinical Solutions, Nicole leads a high-performing global team of data managers to ensure high quality, efficient clinical data management services for biopharmaceutical clients by leveraging advanced technology and nurturing skills. Personally, Nicole strives to be a collaborative thought leader and promoter of health equity in the life sciences industry, driving transformative strategies that ensure all patients have access to treatment regardless of their ethnicity, geographic location, and socio-economic background.
Chief Transformation and AI Officer, eClinical Solutions
Venu Mallarapu is an executive leader at the intersection of AI strategy, clinical data innovation, and large-scale operational transformation. As Chief Transformation and AI Officer at eClinical Solutions, he defines and leads the company’s enterprise AI strategy in partnership with the CEO, with board-level oversight, translating vision into execution across the organization and its client base.
Since 2025, Venu has spearheaded eClinical’s Enterprise AI initiative, establishing the governance framework, value measurement framework, and technology strategy driving toward a 20% enterprise-wide productivity improvement. Working with partners including OpenAI, Anthropic, AWS, Databricks, and Snowflake he is helping embed intelligent capabilities across the elluminate Clinical Data Cloud® and eClinical’s global delivery model.
