Design with the end in mind
|📅 Thursday, December 01, 2022 | 1pm EST (12pm CST / 10am PST) 60 min
This webinar has passed. Find a link to the webinar recording at the foot of this blog.
The FDA requires study data to be submitted using the Clinical Data Interchange Standards Consortium (CDISC) SDTM format, to ensure it can be easily understood and processed. As a result, clinical trial sponsors must decide whether to align with SDTM from study build, before collecting any patient data, or take on the challenge of mapping and converting data to SDTM once it has been collected.
It’s a decision we see organizations battling with all the time. That’s why we’re partnering with healthcare technology company Mednet to deliver this free webinar on the subject of ‘designing with the end in mind’. We’ll discuss the benefits of this approach, including how it can accelerate and improve the quality of CDISC SDTM deliverables.
Who should attend?
The webinar will be beneficial for individuals involved with the selection and implementation of a clinical metadata repository (CMDR) within their organization. It will also be invaluable for those looking to introduce standardization to their clinical trials. This includes people working in data standards, data management, regulatory compliance and governance within pharmas, biotechs, CROs, universities and medical device organizations.
What will you learn?
The retrospective approach to SDTM conversion might seem like a safe and familiar solution, but it requires time-consuming programming to get the collected data into the right format, and carries the risk of incomplete data, terminology problems and non-compliance.
By designing with the end in mind, SDTM conversions can be done as soon as patient data is collected. Data can be visualized immediately and quality can be monitored in real time, allowing clinicians to analyze results and make timely and informed decisions during the study. Ultimately, this approach means new treatments will make it to market more quickly.
In the webinar, leading industry experts will cover the following:
- Why the Clinical Data Acquisition Standards Harmonization (CDASH) design is the optimal method of data collection
- How delays in trial submission can be avoided by designing target SDTM datasets and mapping these to raw datasets upfront
- The benefits of aligning with CDISC standards from the study design stage
- How technology supports compliant study design and build and enables earlier SDTM conversions and faster access to data
- Scott Robertson, Vice President Sales, Global Partnerships, Mednet
- Mark Wheeldon, CEO, Formedix
- Ed Chappell, Solutions Consultant, Formedix
The webinar, hosted by Xtalks, took place on Tuesday, 1 December 2022. Listen to the recording by clicking the button below: