042920 CSA Webinar On Demand Copy
Declutter the Data in your Clinical Trial: Mitigate Risk Before it Becomes an Issue
The COVID-19 global pandemic is something not seen in modern times. The clinical trial landscape is rapidly evolving. The FDA and EMA have released guidance on the impact of COVID-19 on clinical trials, recognizing the likely need for amendments, and identifying mitigation measures including centralized monitoring, secure drug supply delivery to home, and alternative methods of safety assessments.
Successfully adapting to the challenges created by the pandemic, including trial virtualization, the increased use of eCOA, ePRO, wearables/sensors, and centralized monitoring all require a critical approach to ensure continued trial momentum.
What if you could proactively detect issues and remediate efficiently? How valuable would it be to process real-time data from disparate sources? How would overall trial execution improve with resource efficiencies realized?
Learn how machine learning technology has the power to:
- Connect data from multiple sources to discover the known and unknown risks
- Maintain focus on data quality and patient safety amid centralized monitoring and reduced monitoring capacity
- Generate real-time data insights that help operational staff identify issues, mitigate risks and ensure focus on patient safety
Join us for a discussion and Live Q&A Chat on how to find errors, trends, and anomalies in data—through a number of statistical algorithms and tests that do not require programming—while integrating this process as part of your risk process improvement.
Executive Director, CDS Strategic Technology Advancement Team, Biometrics, Clinical Solutions
Josh leads the Strategic Technology Advancement Team within the Biometrics business unit at Syneos Health. He drives the use of innovative and advanced technologies within Syneos Health, collaborating with sponsors, operations team, and technology providers to deliver fit-for-purpose and targeted solutions to support the advancement of clinical development. During his 20 years of experience in clinical research, he has lead data operations and technical implementation teams, and worked closely with a wide range of sponsors and industry-leading technology providers. He is an active participant and contributor to the SCDM’s Innovation Committee and Medidata NEXT.
Senior Engagement Consultant
Medidata, a Dassault Systemes Company
Megan has over 18 years of hands-on and leadership experience in clinical operations, clinical site monitoring, CRA/monitoring team management, establishing and leading strategic innovation initiatives and work streams pertaining to site monitoring/management, establishing new OPs/processes/procedures, quality plans, etc. Her last 7 years have been focused on Risk Based Monitoring, primarily at PRA Health and PPD. Megan joined the CRO industry in 2001 as a clinical research associate, gaining valuable hands-on site monitoring experience. Since then, she has held positions of increasing responsibility, most recently as Senior Director of Clinical Operations at Odonate Therapeutics. Megan loves to grow teams and collaborate on innovative ways to improve processes. At Medidata, Megan supports CSA and RBQM and collaborates with clients on implementation and process.