Summary
In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, and Jenna Rouse, Global Head of Clinical Operations at Simulations Plus discuss the benefits of simulation-based clinical research training, which allows sites to practice protocol-specific tasks without risking patient safety. Jenna shares a case study where simulation training improved procedural accuracy from 14% to 86% over six months. The discussion emphasizes the importance of effective training in clinical trials to ensure compliance and patient safety.
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Guest Profile – Jenna Rouse
Jenna Rouse is the Global Head of Clinical Operations at Simulations Plus and a seasoned operations leader with 20+ years of experience helping organizations scale. She’s worked across public accounting, nonprofits, and high-growth companies, partnering with executive teams to turn strategy into results — including recently shuttling a tech-enabled startup to a successful exit. Jenna is known for her collaborative leadership style and ability to bring teams together to get things done.
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Introduction to Court Square Group and the Podcast
- Keith Parent introduces himself as the CEO of Court Square Group, a managed service firm specializing in IT infrastructure for life science companies.
- The podcast aims to discuss various facets of the life science business, highlighting the diverse roles and responsibilities within the industry.
- Court Square Group offers an Audit Ready Compliant Cloud (ARCC™) for hosting and managing applications from preclinical to manufacturing stages.
- The company has developed a platform called RegDocs365™, a content repository for clinical and regulatory content, including TMF and EDM reference models.
Keith Parent Introduces Jenna Rouse
- Keith Parent introduces Jenna Rouse, the Global Head of Clinical Operations for Simulations Plus, to discuss her role.
- Jenna Rouse has extensive experience in clinical research, having spent 16 years with ACRP in business operations, competency development, and marketing.
- Jenna shares her journey from ACRP to Pro-ficiency and later to Simulations Plus, highlighting her 21 years in clinical research and education.
- Simulations Plus acquired Pro-ficiency about a year and a half ago, integrating its bio simulation and data modeling approach with Pro-ficiency’s protocol-specific training.
Jenna Rouse’s Role and the Impact of Simulation Training
- Jenna explains the Pro-ficiency solution, which focuses on simulating real-life scenarios for clinical sites to practice protocol-specific training.
- Simulation training allows sites to make mistakes in a controlled environment, improving learning and reducing errors in patient care.
- The training approach is common in high-risk industries like aviation and medicine, helping to ensure compliance and quality in clinical research.
- Jenna emphasizes the importance of simulation training in driving quality from the start of a study, reducing deviations and improving overall study outcomes.
Challenges and Benefits of Simulation Training
- Jenna discusses the challenges of implementing simulation training during the busiest time of a study but highlights the long-term benefits.
- Sponsors and CROs have seen significant improvements in study quality and compliance after adopting simulation training.
- The training approach is tailored to the needs of different sites, providing more coaching and learning for those who need it most.
- Simulation training helps sites retain information better, reducing the need for repeated training and improving overall study efficiency.
Keith Parent and Jenna Rouse on Training and Compliance
- Keith and Jenna discuss the importance of training in the life science industry, particularly in IT and clinical operations.
- Jenna explains the limitations of traditional training methods like PowerPoint decks and investigator meetings, which often fail to ensure understanding and retention.
- Simulation training offers a more effective and engaging approach, providing real-time feedback and coaching to improve learning outcomes.
- The conversation highlights the need for continuous training and adaptation to different protocols and study complexities.
Case Studies and Real-World Impact
- Jenna shares a case study where simulation training significantly improved procedural accuracy and reduced costs.
- The initial training revealed a high error rate, but reissuing the training with adjusted parameters led to a significant improvement in compliance.
- The case study illustrates the long-term benefits of simulation training, even when initial training results are less than ideal.
- Jenna emphasizes the importance of starting clinical trials with effective training to ensure quality and compliance from the beginning.
Final Thoughts and Future Directions
- Keith and Jenna discuss the potential for future developments in simulation training and its impact on the life science industry.
- Jenna highlights the importance of thinking differently about training and compliance to improve study outcomes and patient safety.
- The conversation concludes with a focus on the value of simulation training in driving quality and efficiency in clinical trials.
- Keith expresses his appreciation for the discussion and looks forward to future conversations on similar topics.