Strategic Data Monitoring (SDM) is an innovative monitoring solution that allows CROs to utilize data-driven processes to produce advanced metrics for the better management of clinical trials. This webinar explores how the INC Research approach to SDM allows resources to be focused on high quality, value-add tasks while ensuring patient safety, data quality and integrity.
Strategic Data Monitoring is aligned to risk-based monitoring conceptually, but is enhanced with the implementation of deep therapeutic expertise, defined processes and unique tools. Our approach includes an upfront evaluation of the protocol or project to assess the risks. This evaluation allows for the development of a fit-for-purpose operational approach that may include targeted source data verification, triggered monitoring activities, as well as on-site and centralized monitoring.
Jill Collins of INC will discuss the INC Research SDM approach as well as the implementation of innovative technology tools that make this approach a viable option for improving efficiency in clinical trials.
Steve Young, Senior Product Director at Medidata Solutions will discuss how life science companies can use technology to implement a strategic monitoring program. He’ll describe how to design and execute a partial SDV strategy and proactively identify emerging site quality issues, informing site management decisions.
Jill Collins, Senior Director, Clinical Innovation, INC Research
Jill Collins, Senior Director, Clinical Innovation, INC Research, has more than 18 years experience in the clinical research industry. At INC Research, Collins is leading the development of INC’s Strategic Data Monitoring and other innovative solutions for delivering clinical trials. She has experience in clinical operations quality management, integrating processes and technologies and clinical trial management. She holds an advanced degree in Clinical Research Administration from the George Washington University.
Stephen Young, Senior Product Director, Medidata Solutions
Stephen Young, Senior Product Director, Medidata Solutions Worldwide Stephen Young is Senior Product Director at Medidata Solutions Worldwide. Stephen brings more than 15 years of experience in driving change and implementing technologies within clinical development organizations, most recently as head of eClinical Services for J&J Global Clinical Operations. In his current role, Stephen leads the development of Medidata’s Insights and site monitoring solution portfolios, providing customers with turnkey metrics and analytics-driven solutions to improve site monitoring workflows. Stephen received his BSc in Mathematics from St. Joseph’s University, Philadelphia, US and his MA in Mathematics from Villanova University, Philadelphia, US.
Who Should Attend?
The target audience includes clinical research professionals interested in learning about alternative clinical trial delivery strategies: Director and manager level executives at pharma/biotech/device companies, clinical outsourcing, clinical operations management, and clinical quality management.
INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women’s health trials. The company’s The Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina. For more information please visit www.incresearch.com.