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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.
Citation preview
SharePoint as a Platform in a Highly Regulated Environment
About Perficient
Strategic Goals for the Solution
Technology Goals for the Solution
Solution Overview
Impact and Benefits of the Solution
Agenda
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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.
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
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Perficient brings deep solutions expertise and offers a complete set of flexible services to help clients implement business-driven IT solutions
Our Solutions Expertise & Services
Business-Driven Solutions
• Enterprise Portals
• SOA and Business Process Mgmt
• Business Intelligence
• User-Centered Custom Applications
• Interactive Design
• CRM Solutions
• Enterprise Performance Management
• Customer Self-Service
• eCommerce & Product Information Management
• Enterprise Content Management
• Enterprise Resource Planning
• Management Consulting
• Industry-Specific Solutions
• Mobile Technology
• Security Assessments
Perficient Services
End-to-End Solution Delivery
IT Strategic Consulting
IT Architecture Planning
Business Process & Workflow Consulting
Usability and UI Consulting
Custom Application Development
Offshore Development
Package Selection, Implementation and Integration
Architecture & Application Migrations
Education
Interactive Design
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
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Main Message Leveraging new technology in the
clinical research environment
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What compliance requirements exist in your business?
HIPAA 28%
FDA Title 21 CFR Part 11 23%
Other 60%
N/A 24%
Poll
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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
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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
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Solution Overview
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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
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Solution Structure
Platform
Study A
Study C
Study B
Platform Level
Study Level
www.perficient.com | Proprietary & Confidential
Solution Overview Participating sites identify
event for review Client identifies events
requiring review
All required information is captured in the solution. Users rely on this information to determine the
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 • 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
ACQUISITION PROCESS
VALIDATION PROCESS
ADJUDICATION PROCESS
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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%
Poll
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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
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Data Acquisition
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Data Acquisition
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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
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Data Validation
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Data Validation
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Data Validation
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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
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Adjudication
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Adjudication
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Adjudication
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Adjudication
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Adjudication
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Adjudication
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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
Reports, Dashboards & Audits
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Reports, Dashboards & Audits
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Reports, Dashboards & Audits
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Reports, Dashboards & Audits
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Reports, Dashboards & Audits
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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)
Solution Impact & Benefits
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On Twitter: @Perficient_MSFT
Our Microsoft Blog:
blogs.perficient.com/microsoft
To register for upcoming webinars:
perficient.com/webinars
Get in Touch with Perficient
