Crossing the Threshold: Clinical Portals from a Site Perspective

Copyright © Intralinks 2013 all rights reserved
Crossing the Threshold:
Clinical Portals from a
Site Perspective
Joan Chambers
Chief Operating Officer
Kevin McNulty
Director, Life Sciences Product Marketing
Intralinks
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Copyright © Intralinks 2013 all rights reserved 2
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Agenda
Introductions
•  Joan Chambers, COO, CenterWatch
•  Kevin McNulty, Director, Life Sciences Product Marketing, Intralinks
Overview of Objectives and Key Findings
Data Findings from the Site’s Perspectives
Questions

A Clinical Portal Defined
“An online gateway for study teams,
sites, monitors, IRBs and others
involved in the planning and
conduct of a clinical trial to access
all clinical systems data and
resources in a secure, controlled,
and compliant manner.”
“A website that brings information
together from diverse sources in
a uniform way.”
“A doorway, gate or
other entrance.”
* Source: Webster’s Dictionary

Overview of Objectives / Key Findings
Purpose
Gain a better understanding of how investigative sites currently perceive clinical
web portals.
Respondents
N = 551, representing sites from North America, Europe, Asia Pacific and other
regions; 58% = CRCs, 24% = Investigators
Key findings
•  Overall, investigative sites manage a significant number of studies and
collaborate with numerous organizations on each individual study
•  Among those investigative sites that use clinical web portals, the majority
access multiple clinical web portals across studies
•  Among those investigative sites that use clinical web portals, the majority
access multiple clinical web portals across studies
•  The top benefits associated with clinical web portals are easier tracking of
information, reduction in paper usage, and instant access to the most up-to-
date information

Overview of Objectives / Key Findings
Key
findings
•  Storage of investigator site files is either paper-based or combination of paper and
electronic files
•  Electronic files easier for backup and disaster recovery
•  Collection of Sponsor/CRO documents
•  Most investigative sites use 6 or more different logins/passwords to access online
clinical systems across all of their research studies
•  Types of information investigative sites most want to view when accessing a clinical
web portal:
•  Query status, study/regulatory documents, training materials, study
announcements, study status and timelines, and patient recruitment information
•  Investigative sites place high importance on accessing web portals:
•  Overall ease of use | Ease of navigation | Easy to find and well organized study
documents
•  80% of respondents agreed that accessing a single web portal would be “Very to
Extremely Valuable”

Data Findings from the
Site’s Perspectives
7
Kevin McNulty
Director, Life Sciences Product Marketing
Intralinks

Why a Clinical Portal Now?
•  Increasingly global: Clinical trials are becoming more
global and distributed in nature
•  More people: The number of individuals involved in
conducting a clinical research has increased
•  More complicated workflow: Different requirements
and regulations in different countries and regions, plus a
trend towards outsourcing
•  “Digitization” of data: New technology for collecting,
accessing and managing clinical information
•  Access demands: Mobile devices have made it easier
to access information when you need it, where
you need it
•  Demand for simplification: Too many silo’ed systems,
too many log-in IDs & passwords, redundancy, etc.

Number of Clinical Studies Conducted
on an Annual Basis

Number of Organizations Typically
Work with on a Single Clinical Study

Type of Storage for Investigator Site Files
Half of respondents
have a combination
of paper and
electronic files.

Type of Information Requested
Most Often from Sponsors/CROs
Answers to protocol
inquiries is the most
often requested
information from
sponsors/CROs.
Answers to study protocol inquiries
Update on CRF inquiries
Contact information
Technical support
Patient recruitment planning and support issues
Grant payment status updates
Update on AE/SAE inquiries
Other
83%
39%
36%
35%
34%
33%
29%
2%

Information Most Want
to Compare Across Sponsors
Patient enrollment timelines
across sponsors, followed by
study activation/start-up time
are predominantly the two
types of information
respondents would most like
to compare.
Patient enrollment timelines
Study activation/start-up time
Query turnaround times
Grant payments/other financial information
Patient retention rates
Other
59%
53%
47%
47%
32%
3%

Number of Different Online Logins/Passwords to
Access Online Clinical Systems

Number of Different Online Clinical Systems
Typically Accessed on a Single Clinical Study

Number of Clinical Web Portals
Accessed Across Studies

Type of Information Most Likely to be Seen When
Logging Into Clinical Web Portal
1%
7%
8%
13%
19%
22%
28%
28%
29%
38%
39%
40%
45%
45%
46%
51%
Other
Study close-out criteria
Contracts & budget changes/updates
Activation/study start-up status
Grant payment status or other financial information
Drug supply information
Milestones/due dates
Patient recruitment resources/tools/guidelines
Schedules (monitor visits/etc...)
Patient recruitment/enrollment
Study calendar/timeline
Study status
Study announcements/changes
Training documents
Study/regulatory documents
Query status
The types of
information most
respondents would
like to appear in a
web portal include
query status, study/
regulatory
documents, training
documents, study
changes, and study
status.

The most important
attributes include
general ease of use,
ease of navigation, and
well-organized/easy to
find study documents.
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Importance of Clinical Web Portal Attributes
14%
21%
26%
26%
38%
44%
46%
61%
63%
67%
68%
73%
Ability for patients to communicate in an online forum
Ability to communicate with other sites/peers
Ability to search on keywords within web portal on specific topics
Ability to access the web portal using tablet devices
Availability of comprehensive training program
Ability to print specific content from web portal
Relevant sponsor/CRO contact info easily found and readily available
Efficient uploading/downloading of study documents/patient files
Readily available technical support/customer service
Study documents are well-organized/easily found
Ease of navigation through web portal
General ease of use
Percent Rating 4 or "Very Important"

5%
2%
6%
10%
18%
19%
20%
20%
24%
25%
38%
41%
50%
Other
It improves patient retention rates
It improves patient enrollment efficiency
Faster study start-up
It reduces the possibility of human error
It improves the response time from sponsor/CRO
It improves adherence to the study protocol
It reduces the amount of time I have to spend on study management
It reduces the number of systems I need to use when communicating with sponsors/CROs
Better overall collaboration with sponsors/CROs
I can get the most up-to-date information right away
It reduces the amount of paper we use
It is easier to keep track of information
The primary benefits
associated with web
portals include easier
tracking of information,
reduction in paper usage,
and instant access to the
most up-to-date
information.
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Primary Benefits of Using Clinical Web Portals

Value of One Web Portal to Access
Studies Across Multiple Sponsors/CROs
The majority of respondents agree that a single web portal with one
login/password across multiple sponsors/CROs would be very valuable.
80%17%3%
10 = Extremely Valuable
Mean Rating = 8.7
1= Not at all Valuable

Questions?
21
Joan Chambers
COO, CenterWatch
Joan.chambers@centerwatch.com
Kevin McNulty
Director, Product Marketing, Intralinks
kmcnulty@intralinks.com

Crossing the Threshold: Clinical Portals from a Site Perspective

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