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SharePoint as a Platform in a Highly Regulated Environment


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During this webinar, Perficient presents a case study on leveraging Microsoft SharePoint 2010 as a solution platform in a highly regulated clinical drug trial environment to reduce paper and manual processes and adhere to compliance requirements while increasing efficiencies.
The presentation discusses key components of the SharePoint solution, which include:
Workflows and management of user queues to reduce manual processes and increase throughput
Logging and event history that support compliance and customer reporting based on the FDA’s rigorous 21 CFR Part 11
Document management supporting version control and user access throughout business processes
Permissions and security that integrate to existing systems such as Active Directory
Interactive meeting spaces and management of online meetings across multiple users and security roles
Dashboards and reporting that support business processes and proactive user interaction
Integration to internal and external clinical systems
Internal (intranet) and external (extranet and internet) customer support

Whether your enterprise is new to SharePoint or has been utilizing the platform for some time, this recorded webinar will offer valuable insight on the challenges and lessons learned when leveraging SharePoint as a solution platform and an electronically based compliance solution in a highly regulated environment.

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SharePoint as a Platform in a Highly Regulated Environment

  1. 1. SharePoint as a Platform in aHighly Regulated Environment
  2. 2. AgendaAbout PerficientStrategic Goals for the SolutionTechnology Goals for the SolutionSolution OverviewImpact and Benefits of the Solution 2
  3. 3. About PerficientPerficient is a leading information technology consulting firm serving clientsthroughout North America.We help clients implement business-driven technology solutions that integratebusiness processes, improve worker productivity, increase customer loyalty andcreate a more agile enterprise to better respond to new business opportunities.
  4. 4. Perficient Profile Founded in 1997 Public, NASDAQ: PRFT 2011 Revenue of $260 million Major market locations throughout North America — Atlanta, Austin, Charlotte, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Los Angeles, Minneapolis, New Orleans, Philadelphia, San Francisco, San Jose, Southern California, St. Louis and Toronto Global delivery centers in China, Europe and India 2,000+ colleagues Dedicated solution practices 87% repeat business rate Alliance partnerships with major technology vendors Multiple vendor/industry technology and growth awards 4
  5. 5. Our Solutions Expertise & ServicesBusiness-Driven Solutions Perficient Services• Enterprise Portals  End-to-End Solution Delivery• SOA and Business Process Mgmt  IT Strategic Consulting• Business Intelligence  IT Architecture Planning• User-Centered Custom Applications  Business Process & Workflow• Interactive Design Consulting• CRM Solutions  Usability and UI Consulting• Enterprise Performance Management  Custom Application Development• Customer Self-Service  Offshore Development• eCommerce & Product Information  Package Selection, Implementation Management and Integration• Enterprise Content Management  Architecture & Application Migrations• Enterprise Resource Planning  Education• Management Consulting  Interactive Design• Industry-Specific Solutions• Mobile Technology Perficient brings deep solutions expertise and offers a complete set of flexible services to help clients• Security Assessments implement business-driven IT solutions
  6. 6. Our SharePoint Expertise is #1SharePoint is HOT!Perficient is one of the strongest, largest, most trusted SharePoint partners inthe United States. 400+ professionals in the SharePoint practice area Leader in cloud-based SharePoint Online implementations 500+ SharePoint projects One of 20 companies worldwide on Microsoft Partner Advisory Council for SharePoint Hired by Microsoft to build SharePoint 2010 demo for Microsoft Technology Centers (MTC) Early access to software and training via Product Group relationships Defined competencies in infrastructure, development, design, and strategy Strong partnerships with Nintex, NewsGator, AvePoint, Telligent, and Metalogix 6
  7. 7. Main MessageLeveraging new technology in the clinical research environment 7
  8. 8. Poll What compliance requirements exist in your business? HIPAA 28% FDA Title 21 CFR Part 11 23% Other 60% N/A 24% 8
  9. 9. Strategic Goals of the Solution  Initiate and track the clinical process workflow for relevant documents, events, data, and adjudication results, customized for a specific trial or sponsor  Support interaction with and collaboration between client and external resources as part of the overall clinical event review process through web-based access  Provide metrics across processes, financial support, and personnel roles within the system  The platform will bring the client into a paperless, collaborative, auditable (21 CFR compliant) environment 9
  10. 10. Solution Technology and Capabilities  Adjudication process automation  Import/export sponsor data from Clinical Data Management Systems (CDMS)  Automated data and document loading  Built-in quality control (QC) process and metrics  Faculty review tracking and committee attendance reports  Web-based adjudication platform (Global Outreach)  Metrics across the workflow including adjudication results  System reporting and analysis  Workflow auditing 10
  11. 11. Solution Overview 11
  12. 12. Solution Overview  SharePoint 2010  Leverages native SharePoint 2010 components  Perficient extended the platform to support complex workflow, electronic signature, detailed auditing and comprehensive reporting  Platform components  SharePoint 2010  Forefront Threat Management Gateway (TMG)  SQL Server Reporting Services 12
  13. 13. Solution Structure Platform Level  Study A Study Level   Platform Study Study B C 13
  14. 14. Solution Overview Participating sites identify Client identifies events ACQUISITION PROCESS event for review requiring review All required information is captured in the solution. Users rely on this information to determine the VALIDATION PROCESS disposition of the event. The solution determines the correct path based on event information. Once the event is cleared for processing or “clean” the adjudication process begins. Based on the configuration of the event, the following actions are taken by the solution: • Phase I processing • Specialty processing ADJUDICATION PROCESS • Phase II processing • Quality Control processing The solution also provides the following capabilities: • Data change processing • Data transfer to study sponsors • Reporting and analytics related to the | Proprietary & Confidential 14
  15. 15. Poll Do you currently have or are you planning a solution on the SharePoint platform? We have a solution on the SharePoint 2007 platform. 45% We have a solution on the SharePoint 2010 platform. 52% We are planning a solution on the SharePoint 2010 platform. 26% We are waiting for the SharePoint 2013 platform release. 4% 15
  16. 16. Data AcquisitionKey SharePoint Components Standard SharePoint Lists and Libraries Custom workflow to support validation process Custom actions via the item menu and ribbon Automated and manual data load options Custom processing to determine the fidelity of inbound files 16
  17. 17. Data Acquisition 17
  18. 18. Data Acquisition 18
  19. 19. Data ValidationKey SharePoint Components Standard SharePoint Lists and Libraries Custom workflow to support validation process Custom actions via the item menu and ribbon Custom dialogs to support validation requirements 19
  20. 20. Data Validation 20
  21. 21. Data Validation 21
  22. 22. Data Validation 22
  23. 23. AdjudicationKey SharePoint Components Standard SharePoint Lists and Libraries SharePoint Document Set functionality Dashboard view of work to be completed and actions to be taken List based queues for workflow participants Custom workflow to support multi-stage adjudication process Custom actions via the item menu and ribbon Custom dialogs to support validation requirements 23
  24. 24. Adjudication 24
  25. 25. Adjudication 25
  26. 26. Adjudication 26
  27. 27. Adjudication 27
  28. 28. Adjudication 28
  29. 29. Adjudication 29
  30. 30. Reports, Dashboards & Audits Key SharePoint Components  SQL Server reporting database for reports and Reporting Services  Data extracted directly from SharePoint via ETL  Two-pass security on all reports  Real time dashboards that allow users to manage and prioritize their workload  Clickable components within the dashboard to jump to details  Custom audit logging to ensure that all aspects of the adjudication process are accounted for and traceable 30
  31. 31. Reports, Dashboards & Audits 31
  32. 32. Reports, Dashboards & Audits 32
  33. 33. Reports, Dashboards & Audits 33
  34. 34. Reports, Dashboards & Audits 34
  35. 35. Solution Impact & Benefits  Ease of Use  Expand Outreach  Increase Specialty Physician Participation  Reduce Costs  Travel Costs  Printing Costs  Mailing Expenses  Performance Metrics  Expand Global Academic Opportunities  Increase Sponsor Satisfaction (Dashboard Capabilities) 35
  36. 36. Get in Touch with Perficient  On Twitter: @Perficient_MSFT  Our Microsoft Blog:  To register for upcoming webinars: 36