SAS Drug Development Integration & PheedIt

Transcription

2 Presentation Overview! What is SAS Drug Development (SDD)? Overview! What is PheedIt? Overview! Why integrate?! How does SDD integrate with other applications Basic SDD architecture SDD connectivity and integration! PheedIt & SDD integration On-board SDD engine! Summary Copyright 2004, SAS Institute Inc. All rights reserved. 2

3 What is SAS Drug Development?! Provides a centralized, controlled, repository for source data, derived data, analyses, reports, programs, logs, templates, documents and other research content.! Enables regulatory compliance for data extraction, transformation and statistical analysis processes.! Integrates with existing systems to provide information management and compliance across the research value chain.! Allows non-technical users to interactively explore research data. Copyright 2004, SAS Institute Inc. All rights reserved. 3

4 SAS Drug Development Primary Functions! SAS Drug Development (SDD) serves as the technology backbone for managing all clinical research information within an organization! Designed to enable collaboration & integration, SDD takes advantages of various technologies beyond those used in the traditional SAS implementation! Core functionality implemented within SDD specifically addresses the need for - Flexible collaboration framework SAS Analysis applications framework Data storage, management & versioning Audit trails of all activities Part 11 compliance Extensive API support for integration and customization Copyright 2004, SAS Institute Inc. All rights reserved. 4

5 SDD Architecture: Overview! Solution is completely Java based! Written to the J2EE spec, not for one particular app server Classic n-tier architecture Presentation layer JSPs, Applets, HTML, struts based Business logic EJBs Reporting and Transformations SAS using Integration Technologies to communicate to Java classes Metadata and Data Store JDBC driver to a relational database Copyright 2004, SAS Institute Inc. All rights reserved. 5

6 Enterprise Guide Enterprise Reporter MS Office Documents Add l WebDAV Engine SAS/Base Clintrial Oracle Clinical EDC / other Generic Data Accessor Interface Documentum Generic Intraspect Document Accessor Other Interface Web Server Basic SDD Architecture: Schematic WebDAV Client Drive Mapping Tool / Windows Web Folders Desktop Applications MS Office Templates SAS Drug Development Data Explorer / Process Editor Browser SOAP/WSDL Version of Services SDD html/jsp Application Data Explorer Comm. Servlet Web Server Object Model Scheduling Audit Trailing Properties Mgmt Remote Document Access Remote Data Access Data Explorer EJB Based Services run In App Server Servlet Filter WebDAV Implementation WebDAV Web Server Metadata Database SAS Server(s) Central User Server Copyright 2004, SAS Institute Inc. All rights reserved. 6

7 Basic SDD Architecture: Program Flow! So how does all this work? Web server handles the user requests, displays the GUI in a web browser Content server handles versioning, locking, external access Metadata is stored in the relational database Data is stored in the relational database or in a file system All reporting, transformations, analysis calculations are done in SAS Almost all functionality can be accomplished without the SDD GUI Copyright 2004, SAS Institute Inc. All rights reserved. 7

8 SAS Drug Development! SAS Drug Development Centralized control & access to all research data Sophisticated data exploration tools Managed SAS programming activities Security, versioning, audit trails & documentation Enabling 21 CFR Part 11 compliance Copyright 2004, SAS Institute Inc. All rights reserved. 8

9 What is PheedIt?! Data Entry Solution for Clinical Studies (CDMS)! Developed by SAS Sweden to GCP standards, PheedIt uses core SAS System functionality as well as Web technologies! Functional overview: PheedIt dictionary administration Variables, modules, studies, investigators etc Study Set-up Data Entry Normal and double data entry Discrepancy Management DCFs, data browsing, AVC Export Export data for analysis & reporting / to SDD Report Engine Generate clinical, performance and system reports Copyright 2004, SAS Institute Inc. All rights reserved. 9

10 PheedIt Solution Components Study Setup! Initiate Study for data entry Data Entry Engine! Data Entry! Double Data Entry! Online Data Validation AE Reports Analysis Analysis DB Database Safety Management! Serious AE reporting! AE Reports Export! Export Study Data Engine! Engine Logical! Engine Meta Data! Study information! Module/Variables Data Validation Manag.! Audit Trial browsing! Clinical Data browsing! Proofreading Lists! AVC (Advanced Checks)! DVM Tracking Report Engine! Std. Reports! Reports Wizards! Performance Reports! System Reports SAS based Clinical Database! Engine Meta Data! Clinical Study Data Audit Trail Copyright 2004, SAS Institute Inc. All rights reserved. 10

11 Why integrate?! Solutions need to be able to talk with each other.. Exchange data and/or meta-data Perform complimentary but unique tasks Maintain consistent and complete audit trail! Facilitate information exchange & process flow improvements.. Efficiency Speed! Meet business requirements in a cost effective way.. Reducing duplicity of work Enabling collaboration Improving quality Copyright 2004, SAS Institute Inc. All rights reserved. 11

12 How does SAS Drug Development integrate with other applications?! From initial design to development completion of SDD, connectivity and integration with other applications has been a key driver.. Robust & secure architecture implemented Multiple integration techniques & options available Adherence to global IT standards throughout! SDD connectivity and integration technologies summarized - WebDAV and Web Drives SDD API / Extension Servlet Web Services Generic Access Interface (GAI) Copyright 2004, SAS Institute Inc. All rights reserved. 12

13 SAS Drug Development: Web Drives & webdav! Provides for direct access to SDD content from a local system! Enables direct integration of SDD content with local applications without any need for the GUI or the API! No coding required! This method does not allow you to drive SDD functionality (for example, run a process) but you can read and write all of the content! Authorization, file access, audit trails, etc. are identical to accessing the content using the GUI! Drive mapping tools are available for Windows from 3rd party vendors (SAS provides one with SDD); Windows includes the ability to define My Network Places in 2000 and XP Copyright 2004, SAS Institute Inc. All rights reserved. 13

14 Enterprise Guide Enterprise Reporter MS Office Documents Add l WebDAV Engine SAS/Base Clintrial Oracle Clinical EDC / other SAS Drug Development: Web Drives & webdav Generic Data Accessor Interface Documentum Generic Intraspect Document Accessor Other Interface Web Server WebDAV Client Drive Mapping Tool / Windows Web Folders Desktop Applications MS Office Templates SAS Drug Development Data Explorer / Process Editor Browser SOAP/WSDL Version of Services SDD html/jsp Application Data Explorer Comm. Servlet Web Server Object Model Scheduling Audit Trailing Properties Mgmt Remote Document Access Remote Data Access Data Explorer EJB Based Services run In App Server WebDAV Implementation Metadata Database SAS Server(s) Copyright 2004, SAS Institute Inc. All rights reserved. 14 Servlet Filter WebDAV Web Server Central User Server

15 Example! Connect to remote SDD server using Web Drive! Browse files with a local client! Run SAS programs locally against content stored in SDD! Use Word to update a document stored in SDD! Example showing SDD as a drive on a local PC is described in available paper Copyright 2004, SAS Institute Inc. All rights reserved. 15

18 SAS Drug Development: API! Most SDD functionality accessible via APIs first time user login and consent must be done via UI! APIs are standard Java Interfaces! Interface itself and Javadoc are provided! Sample code snippets are available for common tasks! Requires some programming experience and knowledge of your network configuration Copyright 2004, SAS Institute Inc. All rights reserved. 18

19 Enterprise Guide Enterprise Reporter MS Office Documents Add l WebDAV Engine SAS/Base Clintrial Oracle Clinical EDC / other Generic Data Accessor Interface Documentum Generic Intraspect Document Accessor Other Interface Web Server SAS Drug Development: API WebDAV Client Drive Mapping Tool / Windows Web Folders Desktop Applications MS Office Templates SAS Drug Development Data Explorer / Process Editor Browser SOAP/WSDL Version of Services SDD html/jsp Application Data Explorer Comm. Servlet Web Server Custom Client Object Model Scheduling Audit Trailing Properties Mgmt Remote Document Access Remote Data Access Data Explorer EJB Based Services run In App Server Servlet Filter WebDAV Implementation WebDAV Web Server Metadata Database SAS Server(s) Central User Server Copyright 2004, SAS Institute Inc. All rights reserved. 19

20 Example! Create an EJB ( Enterprise Java Bean) that queries the audit records of an object in SDD! Build a servlet that displays the audit records in our own format, outside of SDD Copyright 2004, SAS Institute Inc. All rights reserved. 20

21 SAS Drug Development: Web Services! Same functionality as the API but available over the internet can be accessed from both Java and non-java clients (.NET for example)! Becoming the standard for API access in a web based environment! Setup and programming requires familiarity with web services and some programming language that supports interaction with web services Copyright 2004, SAS Institute Inc. All rights reserved. 21

22 Enterprise Guide Enterprise Reporter MS Office Documents Add l WebDAV Engine SAS/Base Clintrial Oracle Clinical EDC / other Generic Data Accessor Interface Documentum Generic Intraspect Document Accessor Other Interface Web Server SAS Drug Development: Web Services WebDAV Client Drive Mapping Tool / Windows Web Folders Desktop Applications MS Office Templates SAS Drug Development Data Explorer / Process Editor Browser SOAP/WSDL Version of Services SDD html/jsp Application Data Explorer Comm. Servlet Web Server Object Model Scheduling Audit Trailing Properties Mgmt Remote Document Access Remote Data Access Data Explorer EJB Based Services run In App Server Servlet Filter WebDAV Implementation WebDAV Web Server Metadata Database SAS Server(s) Central User Server Copyright 2004, SAS Institute Inc. All rights reserved. 22

24 SAS Drug Development: GAI! A GAI (Generic Access Interface) is used by SDD applications to read and write data to and from other external systems.! Uses technology & functionality previously outlined: it is a specific API designed to let other applications read or write content in SDD! GAI used extensively within SDD to talk to Clintrial Oracle/Clinical Documentum A second SDD instance, either distributed geographically or a dev/test/prod setup Local operating environment Other applications Copyright 2004, SAS Institute Inc. All rights reserved. 24

25 Example! Use the Generic Access Interface to copy a document from within SDD to your Documentumbased Electronic Document Management System (EDMS) Copyright 2004, SAS Institute Inc. All rights reserved. 25

28 PheedIt: on-board SDD Engine! The PheedIt SDD Engine uses webdav (Xythos) technology to interact with the SDD environment! The PheedIt SDD Engine exports clinical study data into the SDD environment by - Creating an SDFXML file (Clinical Study Metadata definition) Moving the SDFXML file into the SDD environment Checking (- editing if needed) the SDFXML file via the Study Definition Editor in SDD Moving the clinical study data from PheedIt to SDD Creating a SAS Format control data set within SDD this is based on the PheedIt global format dictionary Copyright 2004, SAS Institute Inc. All rights reserved. 28

31 Summary! There are multiple ways to connect & integrate other technologies, applications and solutions with SAS Drug Development! Each method has specific benefits & drawbacks that need to be assessed with respect to - Functional requirements & level of integration needed IT infrastructure & corporate standards Skills available! Independent of which approach is used, SAS Drug Development provides customers with advanced connectivity & integration capabilities that range from small footprint applications to large corporate solutions. Copyright 2004, SAS Institute Inc. All rights reserved. 31