SGS Mineral Services
VIRTUAL 2020 CDISC US INTERCHANGE
Event Details
SGS is a proud partner and exhibitor of the Virtual 2020 CDISC US Interchange – given the uncertainty of COVID-19 and many corporate travel restrictions, this year’s event is going virtual.
Bringing together the global standards community through the event’s innovative, online format, our experts will be pleased to share this virtual experience and welcome you to our virtual booth and our SDTM presentation. You can also schedule a meeting with our experts.
SDTM PRESENTATION
Clean data one click away: using back-end library rules to clean on SDTM datasets
Data in clinical trials comes from various sources and consequently takes different formats: (e)CRF systems, external vendor data, questionnaires, etc. The variability of this data makes it hard to define, validate and implement standard rules for data cleaning and reconciliation.
Using SDTM datasets during a study for data cleaning, allows the creation of a library of standard electronic rules that can be configured without the need for programming by a clinical data manager.
In this presentation we will demonstrate how this library of rules is used and maintained by sharing practical examples of a case study. We will start with the workflow how to select standard rules from the library and configure them for a specific clinical study. In the next step, the addition of study specific rules is reviewed. The case study ends with the process for the inclusion of a new study specific rule to the overall standard library. The benefits and drawbacks of this system conclude the presentation.
AGENDA
Data cleaning challenges
All2One Tool
Case study
Selecting back-end rules
Creating new rules
Past improvements/future plans
Conclusion
ABOUT VIRTUAL 2020 CDISC US INTERCHANGE
Featuring 40+ presentations over three tracks on two days, this virtual event will equip standards professionals with the most recent industry advancements, technology solutions and best practices, providing a snapshot of the current state of CDISC standards.
LIFE SCIENCE SERVICES
We are a leading contract service organization offering clinical research and bioanalytical testing with specific focus on early stage development and biometrics. Delivering solutions in Europe and in Americas, we offer clinical trial (Phase I to IV) services encompassing clinical project management and monitoring, medical writing, data management, biostatistics, secure data office, PK/PD data analysis, PK/PD modeling & simulation, pharmacovigilance and regulatory consultancy.
SGS biometric group of 300 people is organized for flexible allocation to meet the needs of small, medium and large pharma companies. Our EDC team has extensive experience in customized eCRF build, interactive web response systems and electronic clinical outcome assessment. SGS is a CDISC registered solution provider and has successfully experienced full electronic FDA Submissions for several candidate drugs.
For further information, please contact:
Clinical Research
t: +32 15 27 32 45
SGS Mineral Services
At SGS, we provide independent services that touch the lives of millions of people across the globe. We provide you with industry leading inspection, verification, testing and certification services – anywhere in the world.
When
Wednesday, October 07 and 08, 2020
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