SCOPE Summit

Over the course of four stimulating days of in-depth discussions in 19 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations, including: Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Data Strategy & Analytics, Artificial Intelligence (AI), Sensors and Wearables, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Clinical Biomarker Strategy, Clinical Supply Chain, Precision Medicine, and Biospecimens and Central Lab Solutions.

On February 19th ERT will be presenting on Late Stage Research, Observation Studies at 12:10pm and Implementing Risk Based Monitoring (part 1) at 3:40pm. Be sure to join our sessions and visit our booth to discuss how to advance your clinical trials while minimizing risk and maximizing visibility.

Late Stage Research, Observation Studies

Tuesday, February 19 at 12:10 pm

Using technology to maximize patient choice whilst minimizing burden in post-approval research

Tuesday, February 19 at 12:10 pm

Presenter: Chris Watson, PhD, Director of Product Strategy, Digital Patient , ERT

Implementing Risk Based Monitoring

Tuesday, February 19 at 3:40 pm

Join Rob Bolduc, Director, Product Management, ERT, as he presents “Beyond Risk-based Monitoring: Employing Risk-based Management.”

Discussion highlights include:

  • Exploring process, resource, and technology challenges in implementing risk-based management (RBM)

  • Overcoming challenges in data source variability, data latency and data aggregation

  • Moving beyond RBM: Incorporating study start-up metrics, milestone tracking and other KPIs

  • Complying with ICH E6 guidance: Sponsor / CRO roles in risk-based management and oversight

  • Finding the best model and solution for your organization: The value of pilots and proofs of concept (POCs)