Two of Aperio Clinical Outcomes experts from Clinical Data Management and Programming will present two innovative panel presentations this week at Medidata NEXT 2019. Both panels will take place on Tuesday, November 12th in the New Models for Clinical Development & Drug Approval track.
Tuesday, November 12th, 2:30-3:10 pm
Considerations for Designing Your Virtual Trial: Lessons Learned from Data Management
Aperio Director Data Management Stacey King
Uniformity and standardization is critical within the clinical trial landscape. Data collection and reporting for clinical studies is evolving through implementation of new technologies that allow for direct patient data collection and direct access to electronic medical records. A great benefit for utilizing new technologies is increased accuracy and reduction of data entry redundancy. As the paradigm shift ramps-up, it is vital for clinical research professionals to become aware and be involved in developing processes that encompass these new technologies. However, how often do we take that notion too far and put ourselves or processes in strict requirements that do not allow for creativity or intuitive solutions and tools to help us get to the goal we need to achieve? Mindful proactive planning and analysis must be performed to get the maximum benefit from patient data collected from personal devices. This presentation will share real-world experience providing insights of why careful planning is critical in the name of standardization when using a single platform as the data source for multiple applications (Clinical Data, Safety Data, ePRO, Randomization, Trial Supply, Imaging, etc).
Tuesday, November 12th, 3:40-4:20 pm
The Benefits of a Flexible Database Design for Today’s Complex Clinical Trials
Aperio Senior Clinical Programmer Brian Stoddart
Clinical trials have become more complex than ever. Whether it is planning for multiple Investigational Products (IPs), incorporating an adaptive study design, or managing multiple protocol changes, it is important to implement a database design upfront that will allow for downstream changes to be made to the database quickly, efficiently, and with minimal impact to the existing data.
During this presentation, data management and data programming experts will discuss how flexible database designs present a proactive solution for managing complex trials. Attendees will learn how allowing for fluid data flow can be ideal for studies that will experience numerous changes over the life of the trial, and how this proactive approach provides for easy database modifications with little to no impact on existing data. Using visual representations of best practices, presenters will discuss the benefits of a flexible database design, including allowing for new protocol visits, customizing forms for allowance of additional assessments, and seamless reconfiguration of study events. Attendees will be able to take what they have learned and apply this design model not only to their next initial build, but if necessary, also as a midstream option for their complex clinical trials.
Aperio is a proud sponsor of Medidata NEXT 2019.
To learn more about Medidata NEXT, click here. Alternatively, contact Aperio to learn how we can support your organization’s clinical data management and trial technology needs.