Leveraging SharePoint for Clinical Trial Management

Transcription

1 Bringing your projects to a higher level SM Leveraging SharePoint for Clinical Trial Management 26 April 2011 Presented by Darcy Vieira, Cato Research Canada Jeremiah Rehm, BioClinica by Cato Research Ltd. All rights reserved.

2 Agenda Cato Research s Vendor Selection Process The Integration Challenge Traditional CTMS Model Microsoft SharePoint Separating the Study Data Logistical Data Specification Role-based Data Access Track and Measure Performance Suggested Vendor Questions Bringing your projects to a higher level SM by Cato Research Ltd. All rights reserved.

3 Cato Research Qualified Vendor Database Clinical Trial Management System Patient Recruitment Phase I Units Central IRB Electronic Data Capture Central Laboratory Translational Services Call Center Services Analytical Laboratory Imaging Nonclinical Facilities Drug Packaging/Labeling/ Shipping/Storage API/Drug Product Manufacturer Bringing your projects to a higher level SM by Cato Research Ltd. All rights reserved.

4 Vendor Selection for CTMS Standard operating procedure for vendor selection Identification of potential vendors Based on requirements from different stakeholders throughout the organization Development of vendor questionnaire Points to consider: Size of vendor and facility overview Past project experience Background and experience of personnel Compliance with applicable regulations Internal vendor procedures Referrals Bringing your projects to a higher level SM by Cato Research Ltd. All rights reserved.

5 Vendor Selection for CTMS Evaluate and compare vendor results Demo presentations provided by vendor Identify qualified personnel for further evaluation Set-up of test environments for further evaluation Perform quality assurance audit of vendor Bringing your projects to a higher level SM by Cato Research Ltd. All rights reserved.

6 Leveraging SharePoint for Clinical Trial Management April 26, 2011

7 Today s Clinical Trials Many isolated eclinical systems A multitude of complex study management environments 7

8 Complex Study Logistics 8

9 Today s Study Environment EDC Safety CRO CTMS Clinical Site IVRS Clinical Site Clinical Site CRO Sponsor EDC EDC Clinical Site CTMS Clinical Site Clinical Site 9

10 The Integration Challenge Significant propagation of eclinical applications Multiple product categories, all with overlapping functionality Numerous vendors, each using a unique data specification Targeted research: smaller players, more studies Many more partnerships, acquisitions, and cross-organizational trials Study costs are increasing, while trial budgets decrease Dramatic escalation in selective outsourcing Many specialized CROs offering diverse service models Significant rise in international studies and sites Each vendor s report and/or data export uses a unique format, covers a different timeline, and provides disparate data types 10

11 Transferring Data Between Systems Migration: the one-time population of data into a newly deployed system (e.g. investigator information from an Access database needs to be pre-populated into the CTMS). Periodic Import: the repetitive update of data based on a predefined schedule (e.g. mapping the multiple Excel files provided by various CROs to the sponsor s CTMS). Integration: the automated one-way or bi-directional exchange of data between two systems (e.g. CRF page status transferred from an EDC into the CTMS financial component). 11

12 Traditional CTMS Model CTMS Locally Installed Applets Point-to-Point Connections Office Systems Outside of CTMS EDC IVRS Safety CRM Other 12

13 Next Generation CTMS Multi-Study Management Environment CTMS Microsoft SharePoint User-Targeted Office-Smart Environment Connector Office Systems Outside of CTMS EDC IVRS Safety CRM Other 13

14 Microsoft SharePoint

15 Microsoft SharePoint Sites: the basic capabilities required to engage employees, partners, and customers in an effective manner; both inside and outside the firewall. 2. Communities: the ability to easily access expertise and interact with other people in new and creative ways across the enterprise through both formal and informal networks. 3. Content: the facilities for the creation, review, publication, and disposal of content, including conforming to defined compliance rules, whether the content exists as traditional documents or as Web pages (includes document management, records management, and Web-content management). 4. Search: the capability to enable users to quickly and easily locate relevant content across SharePoint lists, sites and external systems, and other data sources, such as file shares, Web sites, or line-of-business applications. 5. Insights: the ability to not only rapidly deliver and share information that is critical to the success of the business, but also to turn raw data into actionable conclusions and to drive business results through sharing data-driven analysis. 6. Composite Applications: the ability to quickly create customized solutions without involving corporate IT in each request. At the same time, the IT staff needs the capability to empower business users to create these applications while ensuring the environment s stability and availability. 15

16 Clinical Trial Management and SharePoint 1. Leverages existing investment in Microsoft products 2. Creates a more connected and collaborative environment 3. Consolidates cross-platform data for informed decisions 4. Streamlines clinical processes and workflow 5. Simplified workspace significantly improves user adoption 6. Lowers training costs and on-going support expenses 7. Delivers faster return on investment (ROI) 16

17 [Screenshot Slide]

18 [Screenshot Slide]

19 Separating the Study Data Logistical Data Study 1 Study Operational Impact Data Types Study N Clinical Data 19

20 Logistical Data Specification Syntax Data type definitions Define your specification or adopt one Semantics Context within the clinical trial environment Persistence Consistency across studies with ability to extend per study 20

21 Role-based Data Access Microsoft Office ODBC or other DB Connection Microsoft Office System Flat Files (CSV, etc.) CRM Spreadsheets IVRS CDMS Web Services Enterprise Applications and Services Clinical Applications and Services Safety ERP EDC edm CTMS 21

22 Site Visit Calendar CTMS View

23 Site Visit Calendar SharePoint View

24 Site Visit Calendar SharePoint Portal

25 Site Visit Calendar Connect to Outlook

26 Site Visit Calendar Outlook View

27 Populating SharePoint Several technologies and options exist: Business Data Catalog (BDC) User Defined Function (UDF) Web Services and SharePoint Content Types Beware of functional limitations! Connect to Outlook Export to Spreadsheet Open with Access SharePoint 2010 (embedded PerformancePoint analytics, graphical Visio workflow, native esignature functionality, etc.) More than just tracking data for regulatory compliance, use it to measure performance as well as improve operational efficiency via scorecard portals. 27

28 Track and Measure Performance

29 Track and Measure Performance

30 Common Study Functions Clinical Trial Management System Provides controls for regulatory compliance Microsoft SharePoint Presents relevant data to study stakeholders Role-based, study-specific permissions Portals, dashboards, scorecards, etc. Audit trail, version history, record hierarchy, etc. Configurable workflow and alerts Predefined report templates Tracks operational study data and record relationships esignature of document files (SharePoint 2010) Custom workflow and alerts Ad-hoc personalized reports Calculates performance metrics based on operational data points 30

31 SharePoint 2010 Edition Comparison

32 Vendor Questions Do your products support exposing the data being tracked into SharePoint? Exactly what methods or processes do they use to do this? What are the limitations? Is a Test Drive available? Is it one-way only or bi-directional? Which record types specifically? What versions of SharePoint are supported (2003, 2007, 2010)? What flavors are required (WSS, MOSS, Enterprise MOSS)? Is the data specification extensible to include custom information? What security or permission controls are used? Role-based? Study specific? Full Active Directory support vs. Windows Integrated authentication? How is security, compliance, and data integrity ensured? Do you support Validation efforts? IQ/OQ/PQ? 21 CFR Part 11? What data standards do your products support (SDTM, MCC, etc.)? 32

33 Agenda Revisited The Integration Challenge Traditional CTMS Model Microsoft SharePoint Separating the Study Data Logistical Data Specification Role-based Data Access Track and Measure Performance Vendor Questions 33

34 Thank You! BioClinica, Inc. 800 Adams Ave. Audubon, PA (888) Questions? Upcoming Webinars Title: Leveraging SharePoint to Maximize CTMS Adoption and Flexibility Host: Applied Clinical Trials Date/Time: Wednesday, May 11, 2011 at 2:00pm ET Speakers: Les Jordan (Microsoft) and Bob Leonard (Harvard Clinical Research Institute) Free Registration: Title: Source Documentation, Audit Trails and EDC, How Do They Fit Together? Host: Drug Information Association Date/Time: Wednesday, May 25, 2011 at 11:00am ET Speaker: Jonathan Andrus (BioClinica) Free Registration: 34