PDF《Emma Liu, SAS R&D, Beijing, China》

1 PharmaSUG China

2015 - Paper

29 SAS? End-to-End solutions in Clinical Trial Emma Liu, SAS R&

D, Beijing, China ABSTRACT Are you in trouble with executing timely queries against historical or ongoing clinical trials data? Is there confusion of retrieving data from particular trials beyond generating standard reports and analysis across different systems? Are you looking to build a robust integration routine to bring diverse sources of clinical data together repeatedly for different trials? How do you build up a fluent collaboration model with external clinical data management partners? If you answered '

YES'

to any of these questions, then you need to look at the SAS End-to-End solutions in Clinical Trial.

INTRODUCTION LEGO toys are popular because they are flexible, reusable and combinable. Similarly, in this presentation we will discuss how SAS End-to-End solutions resolve above business concerns in Clinical Trial;

we would also like to represent it as SAS LEGO toys in term of playing specific roles in the Clinical Trial with Data Collation, Data Integration, Data Transformation, Data Analytics and Data Exploration. And with a combination of these SAS LEGO toys to SAS End-to-End solutions, we will see: ? How to reuse integrated standards over different components of the clinical data flow. ? How to build up collaboration modules which can be outsourced or split up along different departments according to the business processes. ? How SAS optimize and streamline Clinical Trials from the beginning to the end of working out high-quality submissions to regulatory. And everything of these can be reached in a security and regulatory compliance SAS development environment to save your time on operational data activities and focus more on analytics of the data. DATA MANAGEMENT AND STANDARDIZATION SYSTEM Currently most EDC tools available allow for extracting data in variety of format, but not all support the Clinical Data Interchange Standards Consortium (CDISC) or ODM formats, or the specific versions... Further, many of them come from disparate systems, making it hard to build up a robust integration routine to aggregate diverse sources of clinical data for different trials. In this section, I will introduce one of SAS LEGO toy -- SAS? CDI- Clinical Data Integration to handle above concerns. SAS? End-to-End solutions in Clinical Trail

2 SAS? CDI- CLINICAL DATA INTEGRATION SAS? CDI- a desktop application and the client portion of SAS? DIS - Data Integration Studio, is a tool designed for supporting the pharmaceutical-industry needs for data standardization of creation industry-mandated data standards- CDISC in data aggregating, transforming, managing, and validation (See Display1). By building up in a reusable data structure, SAS? CDI helps you perform clinically oriented tasks such as importing data standards, creating studies and submissions, and adding specialized transformations for mapping clinical data into a standard data model. Throughout the whole process, it produces standards-based data C from the point when the primary clinical data is captured all the way to the point when the standardize data is generated out and ready for the following data analysis report in the hands of regulatory authorities and the pharmaceutical sponsor. Display 1. Data Standardization Process BUSINESS MODULES IN SAS? CDI This section demonstrates

5 business modules in SAS? CDI: ? Module 1-Build up Clinical Study integrate with CDISC standard ? Module 2-Aggregating data from multiple sources ? Module 3-Mapping disparate data to a uniform ? Module 4-Compliance Standard Data validation ? Module 5-Data Transformation Pre Knowledge 1-Transformations SAS? CDI provides some Transformations automatizing your data standardization work (See Display 2). Those Transformations include data management &

standardization work such as importing EDC data, mapping data, transforming data, and validating data. Display 2. SAS? CDI Transformations for Clinical SAS? End-to-End solutions in Clinical Trail

3 Pre Knowledge 2-Automated Job In order to assist clinical professions focusing more on Clinical design or data analysis related investigation works rather than data management &

standardization, SAS? CDI provides Job function. Job is a collection of SAS tasks that create output to ensure that your clinical data management &

standardization work automatically and repeatedly. SAS? CDI Job editor- designed as a graphical user interface with a visual standardization process (See Display 3), enables users to drag different Transformations into Jobs graphical user interface according to their needs, and simply connect the different input and output. And the actual Job background will generate SAS code to execute the job and show logs with exact output results (See Display 4) . Display 3. Job Editor Display 4. Automatic Code Module 1-Build up Clinical Study and Submission with CDISC Standard SAS? CDI provides pharmaceutical professionals to design Clinical Study or Submission (See Display 5) by pre- defined data structure template (See Display 6) based on different phases among Clinical Trial;

which would also be customized by Pharmaceutical professionals for different investigating purpose. This pre-defined data structure integrate with latest version of CDISC standard, and even though old version of CDISC also being included in SAS? CDI, thus creating an efficient operational environment for users to integrate various clinical data from different projects, different sites or different format files into a unique standardized data system. By integrating with CDISC standard, SAS? CDI supports importing SDTM, CDASH, SEND, ADaM domains with metadata tables to your Study, this metadata data structure is robust and reusable to make your clinical investigation work reproducibly and automatically. The version of CDISC sta........