The deployment of business process management (BPM) strategies in a digital world revolves heavily around leveraging software platforms to automate pieces of or even complete processes. Whether you’re in clinical operations, safety and pharmacovigilance, or a back-office department, BPM technology solutions can be used to address virtually any business challenge that involves a process. Experts from Perficient and Appian discussed why and how sponsors and contract research organizations (CROs) can leverage BPM technology to streamline processes while maintaining compliance.

1. HOW TO AUTOMATE CLINICAL, SAFETY, AND BUSINESS
PROCESSES WITH INNOVATIVE TECHNOLOGY

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ABOUT PERFICIENT
Perficient is the leading digital transformation
consulting firm serving Global 2000 and enterprise
customers throughout North America.
With unparalleled information technology, management consulting,
and creative capabilities, Perficient and its Perficient Digital agency
deliver vision, execution, and value with outstanding digital
experience, business optimization, and industry solutions.

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PERFICIENT PROFILE
Founded in 1997
Public, NASDAQ: PRFT
2015 revenue $473.6 million
Major market locations:
Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chattanooga,
Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax,
Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis,
New York City, Northern California, Oxford (UK), Southern California,
St. Louis, Toronto
Global delivery centers in China and India
>2,800 colleagues
Dedicated solution practices
~90% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards

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BPM PRACTICE OVERVIEW
Full Lifecycle
Services
Strategy
Implementation
Operational
• Advisory Services
• Business Value, Strategy/Roadmap
• Process & Organizational Design
• Health Checks (People/Process)
• Product Selection & Architecture
AgnosticTechnology-Specific
• Systems Integration
• Custom Development
• Management Consulting
• Change Management
• Health Checks (Technology)
• QA & Testing
• Education & Training
• Production Troubleshooting
• SupportNET: Managed Support

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PERFICIENT & APPIAN
HOW WE WORK TOGETHER TO HELP CLIENTS
Life
Sciences
Solutions
BPM Group:
BPM &
APPIAN
EXPERTISE
Appian:
LEADING BPM
PLATFORM Life Sciences
Group:
INDUSTRY
EXPERTISE

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FEATURED SPEAKERS
Param Singh
Director, Clinical Operations
Perficient
Evi Cohen
Global Practice Leader, Life Sciences
Appian

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AGENDA
Business Process Management (BPM) Overview
Appian BPM Platform Overview
Appian Use Cases in Life Sciences
Q&A

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INDUSTRY
CHALLENGES
Pressure from patients and patient advocates for
affordable treatments
Pressure from regulatory authorities for high-quality products
Pressure from shareholders for maximum profits
Pressure from customers for greater transparency, without
compromising intellectual property

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BUSINESS PROCESS MANAGMENT
INPUT OUTPUT
A management
approach to
continuously improve
processes and achieve
organizational objects
through a set of
methodologies and
technologies.
PEOPLE PROCESS DATA

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APPIAN PLATFORM
“Appian supports all process
styles…allowing rapid innovation
and discovery.”

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Discovery Pre-clinical Clinical Trials Commercial Launch
PHASE I PHASE II PHASE III PHASE IV
6-7 Years 0.5-2 Years Indefinite
Regulatory Review Scale-up & Mfg.
3-6 Years
Clinical Operations (& CROs)
Regulatory Operations
Pharmacovigilance
Chemistry Manufacturing Controls (CMC)
>IND >NDA >Approval
Clinical
CMC
Regulatory
PV
Compliance
Commercial
IT
HR
APPIAN PLATFORM CAPABILITIES

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“Appian projects are agile, its time to
solution is the fastest among all
vendors, and its projects require fewer
internal and external resources.”
stands for simplicity

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USE CASES

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BUILD YOUR INVESTIGATOR DATABASE
USER GROUP
Potential Investigators
OBJECTIVE
Allow any interested physician
to create a user profile for
consideration as a PI
FEATURES/BENEFITS
• Physician fills out a detailed
user profile
• System automatically notifies
sponsor/CRO
• Sponsor/CRO reviews profile and
approves/declines adding to
investigator database

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AVOID MAILING/SHIPPING DELAYS TO SITES
USER GROUP
Site Personnel
OBJECTIVE
Ensure correct site addresses
are used for correct purposes
FEATURES/BENEFITS
• User corrects address mistakes
(e.g., spelling errors, suite numbers)
• User designates specific addresses
for specific purposes (e.g. payment,
shipping)

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MINIMIZE CHASING SITE DOCUMENTS
USER GROUP
Clinical Document Associates
OBJECTIVE
Automate the process of collecting
updated versions of expiring
documents
FEATURES/BENEFITS
• System automatically notifies
the site when a document is
expiring within 30 days
• System automatically sends a
follow-up notification after 15 days if
the documents is still outstanding

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IMPROVE SITE DOCUMENT COMPLIANCE
USER GROUP
Site Personnel
OBJECTIVE
Improve compliance with site
document requirements
FEATURES/BENEFITS
• Color-coded pie chart provides
visual summary of document
statuses with overall compliance %
• User can drill into each color/status
to see document details
• User can upload and send
documents via the portal

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MINIMIZE SITE PAYMENT INQUIRIES
USER GROUP
Principal Investigators / Site
Payment Coordinators
OBJECTIVE
Empower sites to answer their own
questions about site/investigator
payments
FEATURES/BENEFITS
• Users see a read-only screen that
displays a searchable list of site
payments
• Users can drill into the line items
included in a payment
• Users can submit a payment inquiry
via the portal

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MAXIMIZE TRANSPERANCY INTO KEY METRICS
USER GROUP
Principal Investigators / Site
Coordinators
OBJECTIVE
Empower sites to view key study
metrics, such as query turnaround
and hit rates, and see how they
compare to target rates
FEATURES/BENEFITS
• Users see a read-only screen that
displays key metrics (average
turnaround time, number of
queries/subjects/eCRFs) for sites
• Users can drill into the line items
to further refine the metrics

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SUPPORT OFFLINE TRIP REPORT COMPLETION
USER GROUP
Site Monitors
OBJECTIVE
Allow trip reports to be completed
without needing a reliable internet
connection
FEATURES/BENEFITS
• Offline version of trip report
module available
• When the computer or device is
connected to the internet, offline
version automatically syncs with
CTMS

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ACCELERATE TIME-TO-MARKET
USER GROUP
Clinical operations personnel
OBJECTIVE
Expedite time-to-submission and
time-to-market
FEATURES/BENEFITS
• 32% reduction in end-to-end cycle
time (from 19 days to 13 days)
• 60% reduction in start-up cycle
time (from 12-15 days to 5-6 days)

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MANAGE THROUGHPUT OF SCIENTIFIC EXPERIMENTS
USER GROUP
Shared services team that designs,
executes, and analyzes results of
experiments
OBJECTIVE
Streamline data gathering process
for better reporting and visibility of
experiments
FEATURES/BENEFITS
• Increase in efficiency
• Increase in resource utilization
• Reduction in waste

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IMPROVE PHARMACOVIGILANCE PROCESS
USER GROUP
Drug safety, pharmacovigilance,
and/or medical affairs personnel
OBJECTIVE
Track and manage safety signals to
facilitate accurate reporting and
improved compliance
FEATURES/BENEFITS
• Automated signal management
process
• Improved patient safety
• Mobile dashboards and reports
• Reduced report generation time
• Complete audit trail

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INCREASE EMPLOYEE COMPLIANCE
USER GROUP
Drug safety, pharmacovigilance,
and/or medical affairs personnel
OBJECTIVE
Help employees create, maintain,
and share reliable and timely
information about compliance risks
that relate to the Foreign Corrupt
Practices Act (FCPA) and anti-
bribery and corruption
FEATURES/BENEFITS
• Rapid creation, maintenance, and
sharing of reliable timely risk data
• Standardized business rules to
avoid inadvertent compliance risks
• Role-based access with complete
audit log for compliance

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AUTOMATE CAPEX REQUESTS/APPROVALS
USER GROUP
Back-office contracts management,
finance, and/or procurement
personnel
OBJECTIVE
Automate and accelerate capital
expenditure (CapEx) requests and
approvals
FEATURES/BENEFITS
• Reduction in CapEx and contracts
management cycle by 60% (from
5-7 days to 2 days)

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MANAGE GLOBAL SUBMISSION TIMELINES
USER GROUP
Regulatory personnel
OBJECTIVE
Build process for handling regulatory
submissions across 150+ countries,
creating visibility and awareness
FEATURES/BENEFITS
• Shorter time-to-market for new drugs
across regions and applications
• Increased compliance and
submission quality

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APPIAN USERS

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Next up:
• How to Comply with IDMP Regulatory
Requirements – July 14
• Integrating Siebel CTMS with Medidata
Rave and Veeva Vault – July 21

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THANK YOU