SharePoint as a Platform in aHighly Regulated Environment
AgendaAbout PerficientStrategic Goals for the SolutionTechnology Goals for the SolutionSolution OverviewImpact and Benefit...
About PerficientPerficient is a leading information technology consulting firm serving clientsthroughout North America.We ...
Perficient Profile   Founded in 1997   Public, NASDAQ: PRFT   2011 Revenue of $260 million   Major market locations th...
Our Solutions Expertise & ServicesBusiness-Driven Solutions             Perficient Services• Enterprise Portals           ...
Our SharePoint Expertise is #1SharePoint is HOT!Perficient is one of the strongest, largest, most trusted SharePoint partn...
Main MessageLeveraging new technology in the  clinical research environment                                   7
Poll What compliance requirements exist in your business? HIPAA                                                  28% FDA T...
Strategic Goals of the Solution    Initiate and track the clinical process workflow for relevant     documents, events, d...
Solution Technology and Capabilities    Adjudication process automation    Import/export sponsor data from Clinical Data...
Solution Overview                    11
Solution Overview    SharePoint 2010    Leverages native SharePoint 2010 components    Perficient extended the platform...
Solution Structure  Platform Level                                 Study                                A  Study Level   ...
Solution Overview                                                       Participating sites identify            Client ide...
Poll Do you currently have or are you planning a solution on the SharePoint platform? We have a solution on the SharePoint...
Data AcquisitionKey SharePoint Components   Standard SharePoint Lists and Libraries   Custom workflow to support validat...
Data Acquisition                   17
Data Acquisition                   18
Data ValidationKey SharePoint Components   Standard SharePoint Lists and Libraries   Custom workflow to support validati...
Data Validation                  20
Data Validation                  21
Data Validation                  22
AdjudicationKey SharePoint Components   Standard SharePoint Lists and Libraries   SharePoint Document Set functionality...
Adjudication               24
Adjudication               25
Adjudication               26
Adjudication               27
Adjudication               28
Adjudication               29
Reports, Dashboards & Audits Key SharePoint Components  SQL Server reporting database for reports and Reporting Services ...
Reports, Dashboards & Audits                               31
Reports, Dashboards & Audits                               32
Reports, Dashboards & Audits                               33
Reports, Dashboards & Audits                               34
Solution Impact & Benefits  Ease of Use  Expand Outreach  Increase Specialty Physician Participation  Reduce Costs   ...
Get in Touch with Perficient  On Twitter: @Perficient_MSFT  Our Microsoft Blog:   blogs.perficient.com/microsoft  To re...
Upcoming SlideShare
Loading in …5
×

SharePoint as a Platform in a Highly Regulated Environment

1,381 views
1,292 views

Published on

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.

Published in: Technology
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
1,381
On SlideShare
0
From Embeds
0
Number of Embeds
2
Actions
Shares
0
Downloads
13
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide
  • Adjudication process automationImport/export sponsor data from Clinical Data Management Systems (CDMS)Automated data and document loadingBuilt-in quality control (QC) metricsFaculty review tracking and committee attendance reportsWeb-based adjudication platform (Global Outreach)Metrics across the workflow including adjudication resultsSystem reporting and analysisWorkflow auditing
  • SharePoint 2010 Leverages native SharePoint 2010 components Northridge extended the platform to support complex workflow, electronic signature, detailed auditing and comprehensive reportingPlatform componentsSharePoint 2010Forefront Threat Management Gateway (TMG)SQL Server Reporting Services
  • 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 processwww.perficient.com | 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: blogs.perficient.com/microsoft  To register for upcoming webinars: perficient.com/webinars 36

    ×