1. Data Migration Massachusetts Biotechnology Council 11-July-2008 Brian K. Perry, President BKP Technologies, Inc.

2. Highlights What is Data Migration? Anatomy of Migration Projects Migration Types and Strategies Technical Considerations Validation Considerations

3. What is Data Migration? “Data migration is the process of transferring data between storage types, formats, or computer systems. Data migration is usually performed programmatically to achieve an automated migration, freeing up human resources from tedious tasks.” - Wikipedia

4. What is Data Migration? Data CDMS Safety EDC Preclin Migration & ETL Process Data Warehouse or Datamart Analytics

5. Execution Phase Validation Planning and Analysis Phase Anatomy of Migration Projects Team Selection and Planning Analyze Data Sources Migration Strategy Data Mapping/ Programming Migration Go Live

6. Team Selection and Planning Project Management Clinical Data Management Pre-Clinical Product Safety/Pharmacovigilance Information Technology QA/Validation

7. Analysis of Data Sources – CDMS, EDC or Safety System Direct Database Transfer Flat Data Export Files CDISC or E2B XML Exports SAS Datasets – Other electronic sources Microsoft Excel Spreadsheets Home-grown databases – Paper Documents (Source) – Regulatory Submissions (NDA, 3500A, etc)

8. Migration Types – Single Use End of In-House study End of CRO study Migration from legacy system Acquisition/License of compound/product – Continuous On-going Studies Safety Data and Post Marketing Data

9. Migration Strategies – Single Use Data Formats Full Database Dump Flat File Exports SAS Datasets Structured Files (XML w/CDISC or E2B) Considerations “Cleanliness” of data source Static nature of data

10. Migration Strategies – Continuous Data Formats Full Database Dump Structured Files (XML w/CDISC or E2B) Considerations Dynamic nature of data Ability to adapt to changes in source system Validation on-going

11. Migration Strategies – CDISC/E2B Leverages existing CDISC and E2B export functionality of CDMS, EDC and Safety systems Data mapping is simplified because the standards are defined But…. Not all data in source database may be present in CDISC or E2B

12. Migration Strategies – Database Transfer Provides access to all data fields in the source and destination systems More complicated mapping than CDISC or E2B options May not be an option for single-use migrations where the source system is contained at a partner company or CRO

13. Migration Strategies – Tools Commercial Data Integration/Manipulation and ETL Tools BizTalk Server – Microsoft Corporation Data Junction™ – Pervasive Software Inc. DataMirror Transformation Server™ – DataMirror Corporation Data Transformation Services™ (DTS) – Microsoft Corporation XML Spy - Altova Open Source Tools PERL PHP

14. Technical Considerations CDMS/Safety System view of Data Optimized for Data Entry, Cleaning, Review and Regulatory Submission Preparation Operational and transactional data model Different data models and coded values Data Mart/Data Warehouse view of Data Optimized for data retrieval and analysis Unified data model Unified coding of values Normalized or dimensional model of data

15. Technical Considerations Clinical vs. Safety view of data

16. Technical Considerations Identifying Data Elements Data Fields and Values Derived and Computed Values Coding Dictionaries Events/History – COSTART, WHOART, MedDRA, ICD9/10, Custom dictionary Meds and Products – WHODRL, Custom dictionary Metadata Visit Structure Company Products, Studies, Licenses Code Lists

17. Technical Considerations Data Element Issues Data Type Issues Data Field Size Issues CDSIC and E2B Compliance Issues “Cleanliness” and Integrity of Source Data Transformations of Data Coded Values

18. Technical Considerations Coded Data Events, Medical History and Labs Source data often has a multitude of dictionaries (COSTART, WHOART, MEDDRA, ICD9/10, SNOMED) Issues in maintaining multiple dictionary versions Leveraging auto-encoders Products Typically WHODRL Managing company products Leveraging auto-encoders

19. Technical Considerations Metadata Visit Structure Code Lists Time Units Dosing Units Weight/Age Units Product data (dose units, frequency, formulations, etc.) Lab Codes Causality codes

20. Technical Considerations The “Golden Rule” of data migration Garbage In – Garbage Out

21. Validation Considerations Validation Strategies Tools and Process Data Verification of Data Samples Key Decision Drivers Validation status of source system/data Whether the migration is single-use or continuous

22. Validation Considerations Validation Artifacts User Requirements Technical Specifications/Data Mapping Plan Risk Assessment and Mitigation Migration Master Plan Unit Test Plan and Tests Qualifications Installation Qualification Operational Qualification Performance Qualification (Continuous Migrations) Traceability Matrix Final Report

23. Validation Considerations Qualification Installation Qualification (IQ) of Migration Tools Operational Qualification (OQ) of Mapping/Transforms Performance Qualification (PQ) for Continuous Migrations Data Verification Manual sampling and comparison of cases between data sources and destination safety system Sample Size ANSI Z1.4 (MIL-105) Sqrt(n) + 1 10%

24. Questions and Discussion

25. Contact Information Brian K. Perry President BKP Technologies, Inc. bkp@bkptech.com +1.617.964.2100