FDA now requires drug development firms pursuing approvals to submit all clinical data in CDISC standards such as the Study Data Tabulation Model (SDTM). To meet this requirement, many companies are using labor-intensive, manual and error-prone data extraction and mapping techniques.
There are new solutions leveraging proven technologies that can help expedite and automate the complex processes of data acquisition, aggregation and mapping. These systems provide significant time and cost savings while enhancing data quality for submissions.
This webinar will discuss proven methods and strategies for simplifying the process of acquiring data and transforming it to submission ready formats. The talk will also highlight ways to decrease the manual steps, programming and systems currently used to prepare and analyze data for review from experiences and lessons learned using the elluminate platform by eClinical Solutions.
Speakers
Dave Stein, President & Owner, D. Bartley Consulting
David Stein, president and owner of D. Bartley Consulting, is an eClinical Consultant with over 25 years of leadership and entrepreneurial experience ranging from successful start-ups and M&A to managing clinical technology product portfolios for large corporations. He has specialized in bringing new products, technologies and software to the eClinical market. He co-founded Provenda Biometrics, an early ePRO company, which was ultimately sold to Phase Forward (now part of Oracle). He also led Data Management and Biostatistics for an international CRO. David has authored a number of articles and book chapters and is a frequent speaker at industry conferences.
Message Presenter
Sam Anwar, Vice President, Engineering eClinical Solutions
Sam Anwar has more than 20 years of experience in information technology and software development experience and has focused on developing system for the clinical research industry. In addition to software development, Sam has deep expertise in a diverse set of technologies including IT infrastructure, web technologies, information security, database design, business intelligence, big data platforms and analytics. At eClinical Solutions, Sam oversees IT and leads software engineering with the goal of harnessing cutting-edge technologies to help advance the innovation in life sciences.
Message PresenterWho Should Attend?
- Heads of Data Management, Biostatistics, Clinical and R&D who are currently responsible for data analysis and submissions
- CROs and other third parties who provide data mapping and conversion services
- Consultants working with teams to identify efficiencies and new technologies to support greater output
- Quality leaders who participate in data quality review and support
Xtalks Partner
eClinical Solutions
eClinical Solutions LLC supports life sciences organizations with centralized data services and software to allow them to regain control, combine and interact with their data when and how they want it.
We offer solutions for efficient data acquisition and data management strategies including EDC, combine complex data streams, perform analysis and reporting or convert data into CDISC format quickly and easily. With a sole focus on drug development and a tenured team of data specialists, we work with you to identify a solution suited to your needs. Contact us at www.eclinicalsol.com or call 866-961-3542 and regain control of your data.
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