BRISTOL-MYERS SQUIBB DATA DISCLOSURE & TRANSPARENCY

Transcription

1 BRISTOL-MYERS SQUIBB DATA DISCLOSURE & TRANSPARENCY

2 TRUSTED COMPANY Since 2001, Sylogent systems have been utilized by leading BioPharma companies Publication Planning Data Disclosure & Transparency Study Participant Recruiting Resource Management / HCP Compliance GSK, J&J, Merck, Baxter, Shire, *Astellas, Actelion, Shionogi, Biogen, Takeda, +50 more BioPharma Solutions: Regulatory. Clinical. Medical Affairs. Commercial. Proven Validated Software Development Process: Passed 12+ Big Pharma Audits No Outsource: All Software Design - Deployment and Support by Sylogent employees. Expertise: Validated Software, Registration & Data Disclosure, Data Services PUBSTRAT US Data Disclosure SYQUENCE Enterprise Approvals Patient Recruiting EU Data Disclosure HCP Compliance PROJECTIC 1

3 PROVEN TECHNOLOGY Data. Templates. Locations, Documents. Resource Profiles CTgov & EudraCT Planning, Scoping & Tracking Protocols & CSRs CTMS & SAS Data PROJECTIC SYQUENCE VCTR US Protocol / Results EU Protocol / Results CTgov & EudraCT ENCePP Company Branded Registry WHO 20 / Results Summaries Regulatory Portals IMPORT PUBLISH Drug & Safety Journals & Conferences PubMed Company Study Registry - Excel, Word, PDF CSR Transparency & Patient Recruiting PUBSTRAT Medical Information System Publication Documents & Citations Journals. Conferences. Authors. Document Repository SAM Desktop & Mobile Devices Document Approval & Clearance 2

4 INFORMATION AUTOMATION Import Data EU Protocol US Protocol Scope - review system generated PLAN and scope / un-scope as necessary Adjust - default Project ( document, record, form ) Start, Duration, End US Results EU Results Others Align - resources to Projects / Tasks 3

5 ROBUST SYSTEM IMPORT CTgov & EudraCT CTgov Protocols & EudraCT & CSRs Protocols & CSRs CTMS & SAS Data CTMS & SAS Data IMPORT Drug & Safety PubMed Excel, Drug Word, & Safety PDF PubMed CSR PROJECTIC SYQUENCE PUBSTRAT VCTR PUBLISH CTgov & EudraCT ENCePP CTgov & EudraCT Company Branded Registry ENCePP Regulatory Company Portals Branded Registry Regulatory Portals PUBLISH Journals & Conferences Medical Information Systems Journals & Conferences Documented Repository Medical Information Desktop System & Mobile Devices Excel, Word, PDF Document Repository SAM Desktop & Mobile Devices 4

6 PROPOSED SOLUTION ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 5

7 MAXIMIZE AUTOMATION ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 6

8 MAXIMIZE DATA CONSISTENCY ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 7

9 MAXIMIZE VALUE ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 8

10 SYSTEM DEMO 9

11 IMPORT DATA ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 10

12 CREATE MASTER STUDY FORM ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 11

13 COMPLETE MASTER STUDY FORM ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 12

14 APPROVE MASTER STUDY FORM ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 13

15 APPROVE MASTER STUDY FORM ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 14

16 PLAN & SCOPE PROJECTS ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 15

17 PLAN & SCOPE PROJECTS 16

18 GLOBAL REGISTRATION TEMPLATES BRAZIL 17

19 PUBLISH MASTER STUDY FORM ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 18

20 US / EU REGISTRATION & RESULTS 19

21 HUB & SPOKE WORKFLOW Reviewer Pending Review System Administrator Data Input Owner Process Manager Endorser Pending Endorsement Received New Pending Data Entry Pending Revision Approver Pending Final Approval PROCESS MANAGER Data Entry Complete Review Complete Endorsement Complete Rejected XML OUT 20

22 LINEAR WORKFLOW System Administrator Received Data Input Owner New Pending Data Entry Pending Revision Process Manager PROCESS MANAGER Data Entry Complete Review Complete Endorsement Complete Rejected Reviewer Pending Review Endorser Pending Endorsement Approver Pending Final Approval 21 XML OUT

23 AUTHOR EU & US REGISTRATION FORMS ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 22

24 REVIEW / APPROVE EU & US REGISTRATION RECORDS ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 23

25 PUBLISH EU & US REGISTRATION RECORDS ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 24

26 AUTHOR EU & US RESULTS RECORDS ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 25

27 REVIEW / APPROVE EU & US RESULTS RECORDS ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 26

28 PUBLISH EU & US RESULTS RECORDS ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 27

29 PUBLISH OTHER TRANSPARENCY DATA ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 28

30 PUBLISH OTHER TRANSPARENCY DATA 29

31 MANAGE LOCATIONS /SITES 30

32 REPORTS & DASHBOARDS 31

33 EXTERNAL DATA REQUESTS ECLIPSE BMS TRIALS CTGOV / EUDRACT REG DB CTMS OTHER 32

34 COMPLEX INTEGRATIONS / DATA IMPORT Upload XLS files to sftp Validate Files - File Name - File Type - Binary Format - Logical Format - Record Count - Count Variance Change Data Types & Filter Data Create single record from multiple records Transform single record into stage structured record Apply business rules - P4OR A = > field 1 - IMPACT B = > field 2 Update existing records create New Records Update Data Lists with new values SFTP 1AM EST IMPORT ETL 1 (EXTRACT, TRANSFORM, LOAD) MERGE ETL 2 (EXTRACT, TRANSFORM, LOAD) STAGING PRODUCTION UPLOADS XLS OR XML SYSTEM 1 XLS SYSTEM 2 XLS SYSTEM 2 XLS SYSTEM 3 XLS SYSTEM 4 XLS SYSTEM 4 XLS 33

35 API & WEBHOOKS Configurable Events API HOOKS Save User Login Change State 34

36 LINEAR WORKFLOW 35

37 ROBUST NOTIFICATIONS 36

38 DISCLOSURE GROUP CALL DISCLOSURE GROUP 23 September :00AM EST PHONE MEETING NUMBER CODE GLOBAL PHONE Webex Link URL Webex Link NUMBER PASSWORD TOPICS Industry Update - Bob Paarlberg Review DIA Disclosure Conference EudraCT Update Clinical Trial Regulations Revision to Good Pharmacovigilance Practice / Module VIII Technology Review - John Bangert / Ed Malcolm ENCePP Process Review NIH Comments EU Results - Import of US Result Data EU Results Preview & PDF Print Format Improvements General Discussion 37

39 DATA SUPPORT SERVICES Data Migration - initial / ad hoc data imports Data Feed(s) - scheduled data imports ( extract. transform. load ) Data Upload - automated extract and publish to external systems ( CTgov, RocheTrials.com ) Data Extracts - validated records or data in destination approved format NIH Comments User Management Reports. Dashboards. Alerts. Controlled Data Sets Data Change Requests 38

40 READY! Jack Yeager - jack.yeager@sylogent.com John Bangert - john.bangert@sylogent.com Dawn Albano - dawn.albano@sylogent.com Ed Malcolm - ed.malcolm@sylogent.com 39

41 APPENDIX QUESTIONS FROM BMS Can you load documents into the system that can be viewed on a public website? If yes, please demonstrate. Does the system integrate directly with clinicaltrials.gov and EudraCT by leveraging the published service (WebService or API) Does the system have performance metrics? If yes, please demonstrate. Does the system have Canned reports and dashboards? If yes, please show them and share how other clients use the dashboards. Can the system generate alerts when deadlines are approaching? Can the system distinguish between marketed and investigational products? Automatic notification of approved products in the US and generate approval date Can the system interact with other BMS applications (i.e. Siebel CTMS, WebMethods (miiddleware), Regulatory DocBase applications etc.?) Can there be Separate XML for each study type for registration - (Interventional, NIR, EAP)? Can the XML feed pull from appropriate M&D tabs (i.e. R&D, GM/ GHEOR) in Eclipse? Can the system identify errors in the XML before the file is uploaded to ClinicalTrials.gov (CTD) (i.e. past dates and missing dates or fields)? Or does the system provide screens for users to check data prior to submission to clinicaltrials.gov? 40

42 APPENDIX QUESTIONS FROM BMS (CONT.) Does the system have ability to ignore special characters during the XML? Once a study is Completed, Withdrawn, Cancelled in the XML, can it be automatically removed from the application and prompt a notification to the CTTG? Does the system have the ability for a team (or CTTG?) to temporarily suspend a study from the XML due to a technical/hd issue in Eclipse? Ability to include completed acquired product studies into the CTD for metrics and disclosure of results Ability to manage all types of protocols (i.e. SubStudies, Multi-tumor type, Basket study) Individual FPFVs are tracked in eplan? Ability to utilize the Warning report that exists today or equivalent report Notification once a compound number has a generic name Automatic generation of tradename once obtained Keep existing parameters to exclude non applicable studies (i.e. preclinical) Notification of IRB/Ethics Committee first approval and letter for Non-IND studies? Notification of first submission to FDA of IND protocol (is that tracked in Eclipse?) 41

43 APPENDIX QUESTIONS FROM BMS (CONT.) Allow a manual override when BMS source system is not updated properly and there are technical issues Include a place for the results team to check out records in order to start their process of disclosing results. This would allow the team to remove the study from the registration XML generation Ability to receive notification once any of the checked out results records has a status change (i.e. site recruitment status - is this applicable?, new Planned LPLV final, Actual LPLV Final Does the system have a readable version of the XML (Excel)? Should automatically tick off box (identifying that AE files are required) when study requires posting A simpler way for the programmer to upload the AE file that is not dependent on the naming convention of the file Both CT.gov and EudraCT use xml (different formatting) to upload SAEs and non- SAEs. Does your system produce only CT.gov xmls or does your system have the capability to also produce EudraCT xmls if appropriate data is provided? How long does your system take to produce an xml? Currently, our system only runs once a day at 4 am EST so if programming uploads an AE file at 9am we must wait almost 24 hours to see it appear in our CTT folder. 42

44 APPENDIX QUESTIONS FROM BMS (CONT.) If it is a SaaS solution explain how do you maintain data privacy? If it is a SaaS explain integration features, Security, Scalability and performance aspects? Please provide insights into your architecture and also explain how your solution will keep up with new regulations across the globe? Is your application multi-lingual? Please provide some insight into access model built in your system? 43