Clinical Data Strategy in Action for Complex Clinical Trials
Webinars
April 25, 2024
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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, mixd 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
Watch the recording
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.
Vice President, Global Strategy and Operations, eClinical Solutions
Venu Mallarapu is a digital innovation leader with over two decades of experience in business and IT advisory, strategic consulting, relationship, and delivery management to global life sciences organizations. As eClinical Solutions’ Vice President of Global Strategy and Operations, Venu is responsible for strategic development to meet global demand for the company’s platform and service offerings. He brings his expertise in collaboration and building teams to drive adoption, market expansion and innovation of the elluminate Clinical Data Cloud and eClinical’s Biometrics Services, ensuring current and future clients recognize value as industry needs evolve. Venu is a subject matter expert in Clinical, Regulatory, Quality and Safety & Pharmacovigilance functions, and has delivered Strategy & Transformation Advisory Consulting to top global Pharma, Biotech, Vaccine, and Medical Devices clients. He has spoken at various Life Sciences and Tech industry events and is a recognized thought leader in R&D with published articles.
