The FDA and PMDA are now requiring standardized study data in submissions. PRA Health Sciences has for many years worked to create metadata-driven end-to-end standards not only to comply with these regulatory requirements but to drive efficiency, consistency and quality of their delivery. In this webinar, PRA panelists will demonstrate, through a case study, how they have defined end-to-end standards as interconnected metadata, and developed automations to create Case Report Forms, SDTM and ADaM data sets, and tables, figures and listings. The panelists will also show how through these standards they were able to decrease their effort per unit for various tasks in the process, and will offer recommendations for how the attendees can achieve similar benefits through their end-to-end standards implementations.
Speakers
Kent Letourneau, Executive Director, Global Data Standards, PRA Health Sciences
Kent Letourneau is the Executive Director of Global Data Standards at PRA Health Sciences. Mr. Letourneau has over 25 years industry experience in various roles in Biostatistics, Statistical Programming, Process Optimization and Global Data Standards. He is a member of the CDISC ADaM team and CDISC Advisory Council.
Message Presenter
Hansjörg Frenzel, Senior Principal Clinical Data Standards Consultant, PRA Health Sciences
Hansjorg Frenzel is a Senior Principal Clinical Data Standards Consultant who has been with PRA for over 22 years. Mr. Frenzel started in the industry as a statistical programmer and for the past 11 years has been in roles of process optimization, standards development and automation. Hansjorg has presented numerous papers on standards related topics at PhUSE and other industry conferences.
Message Presenter
Maria Sekac, Senior Principal Clinical Data Standards Consultant, PRA Health Sciences
Maria Sekac is a Senior Principal Clinical Data Standards Consultant who has worked in the industry for over 20 years. She started her career as a data manager at Genta, and Schering-Plough. She then moved into a Standards TA Lead at Merck for a number of years where she was responsible for the development and governance of eCRF, external data and SDTM standards. She has been involved in numerous metadata repository implementations and process optimization projects. Maria has a passion for standards and is a member of the CDISC SDS team.
Message PresenterWho Should Attend?
This webinar is intended for professionals and leaders from CROs, pharmaceutical and biotechnology companies in the following roles:
- Data Standards
- Data Management
- Statistical Programming
- Biostatistics
What You Will Learn
In this webinar, the presenters will:
- Describe the FDA and PMDA requirements for standards
- Show how standards from data collection to analysis can be described as linked metadata, in order to drive automations
- Demonstrate through a case study how implementing end-to-end standards can lead to reduced efforts in tasks from database build to SDTM Mapping, as well as tables, figures and listings development
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PRA Health Sciences
PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results. We offer exceptional experience across all phases and therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to a pioneering embedded model.
Biometrics forms a centralized, global model that integrates Portfolio Management, Biostatistics & Programming and Data Operations. Our Biometrics organization starts with the end in mind, tracking backward along the regulatory pathway to ensure the data are reported, displayed and captured in the most appropriate manner. This multidisciplinary team of top industry experts works closely with clients to develop cost-effective, real world solutions that supports their personal needs and complies with global data and reporting requirements.
At PRA, we love what do because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of numerous drugs now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.
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