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 PROFILEFounded 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

Ag

no

stic

Te

ch

no

log

y-S

pe

cific

• 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 & APPIANHOW WE WORK TOGETHER TO HELP CLIENTS

Life SciencesSolutions

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 LaunchPHASE 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

2929

FOLLOW US ONLINE

• Perficient.com/SocialMedia

• Facebook.com/Perficient

• Twitter.com/Perficient_LS

• Blogs.perficient.com/lifesciences

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