The SAS/UK Clinical Data Management Knowledge Solution. Ian Pimblett Pharmaceutical Business Unit SAS/UK

Transcription

1 The SAS/UK Clinical Data Management Knowledge Solution Ian Pimblett Pharmaceutical Business Unit SAS/UK

2 Project Review Functionality Status Technical Data Structure Study Definition Security Validation & Queries Reporting Summary Agenda

3 Q Project Review: Consultancy Project Consultancy Project undertaken to meet the specific needs of 1 customer : Phase IV marketing studies Did not need a validated system 2 specific studies No Remote Data Entry New SAS site Rapid solution required Ease of use critical SAS Version 6.12

4 Q Project Review: Consultancy Project Project successfully implemented and accepted, on time and on budget: Customer expectations exceeded Site implementation and user training completed in < 3 days Ongoing support of < 0.5 day/month (largely due to changes in customer circumstances)

5 Q Project Review: Consultancy Project The success of this project resulted in extended awareness within the market place The UK Pharmaceutical team carried out some market research

6 Project Review: Market Research Systems currently available: require substantial technical skills, require product specific training, take a long time to set-up, are not flexible enough.

7 Project Review: Market Research Oracle & Domain: Oracle & Dom ain Current Market Leaders Established in market place Based on transaction databases Extensive functionality Best suited to Clinical Phase II and III trials All export to SAS datasets Other

8 Project Review: Market Research Niche Players: Oracle & Dom ain More specific usage Better suited to smaller trials Frequently written in SAS Smaller vendors do not have established reputation within the industry Possible risk for long term support Other

9 Project Review: Criteria to proceed Must meet the identified gap in the market Should not compete directly with key players Support for: Phase I and IV Pharmaceutical trials, Animal Health trials Diagnostics and Devices trials

10 Project Review: Criteria to Proceed Incremental Development of CDMKS Release 1 to include core functionality Additional functionality to follow Must Exploit SAS Web Technology As a result it was decided to redesign the solution with increased functionality and using latest SAS technology

11 Project Review: System Validation System Validation Audit PA Consulting Quality System Development Two Audits to Date Potential Client External ISO CFR Part 11

12 Functionality The system must be able to: enter, manage, deliver clinical trial data.

13 Functionality The system must also be: validated flexible, portable, user friendly, quick to set-up. Meet relevant regulatory requirements

14 Functionality The system to have the options: Stand alone PC Client/Server Client/Server + Web

15 Technical: Data Structure System Keys Primary Keys Secondary Keys Variables - Book, Page, Userid, Datetime - Patient IDs - Visit - Recorded observations

16 Copy Previous Study Technical: Study Definition Use Data Dictionary Create New Variables Dataset Build Environment Data Entry Frame Web Data Entry Frame

17 Technical: Security Users Passwords Roles Study & System level Data System password protected Access only through the System Audit Trail All changes audited Switch-on controlled Cannot be deleted

18 At Data Entry Technical: Validation & Queries Ranges Valid values Informats and Formats Validation Manager Consistency checks using GUI interface More complicated checks programmed & stored Query Manager Results assigned to targets e.g Investigator, CRA Linked to data for drilldown

19 Technical: Reporting Suite of standard metrics reports Adverse Events report Audit report Full data listing User written reports may be added Study data exported to other formats SAS datasets Excel CSV Access

20 Summary: Business Benefits Minimal training Users can be up and running in a few hours. Rapid study set-up Object orientated front end, enables quick and easy database build. Data entry screens built directly from metadata Portable and flexible Full SAS functionality & fully integrated with all other SAS products. GREATLY SIMPLIFIES AND STREAMLINES THE PROCESS OF CLINICAL DATA MANAGEMENT

21 Summary: Status Release 1.0 of Application to be available in U.K. end of May 2001 Release 1.0 to include: data entry (local and/or web) and validation and query management Subsequent Additional functionality to include: Lab loader Autoencoder SAE manager

22 Industry Knowledge Centre CDMK Solution Presentation Thurs 30 th May 9.00 Demo Stands Thurs 30 th May 9.40

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