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.
3. About Perficient
Perficient is a leading information technology consulting firm serving clients
throughout North America.
We help clients implement business-driven technology solutions that integrate
business processes, improve worker productivity, increase customer loyalty and
create a more agile enterprise to better respond to new business opportunities.
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. Our Solutions Expertise & Services
Business-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. Our SharePoint Expertise is #1
SharePoint is HOT!
Perficient is one of the strongest, largest, most trusted SharePoint partners in
the 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
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. 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. 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
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. Solution Structure
Platform Level
Study
A
Study Level
Platform
Study Study
B C
13
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 process
www.perficient.com | Proprietary & Confidential 14
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. Data Acquisition
Key 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
19. Data Validation
Key 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
23. Adjudication
Key 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
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
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
Notas do Editor
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