C O N F I D E N T I A L1

Ensuring Sponsor and Site ROI from Portal Implementation

Alison Shurell – VP, Product Marketing, IntraLinksNOVEMBER 2009

C O N F I D E N T I A L2

Agenda

• Why Web-Based Portals?

• Clinical Portal ROI to Sponsors

• The Importance of Site Acceptance, Adoption and Use of a Portal

• Why Sites Hate Portals: The Challenges

• Why Sites Love Portals: The Benefits

• Clinical Portal ROI to Sites

• Top 10 Things to Consider in Selecting a Clinical Portal

• Q & A

C O N F I D E N T I A L3

Why Web-Based Portals?

SAVES TIME • Web-based solutions available 24/7/365• Instant document distribution & submission• Easy version control and information access• Speeds study start-up process – faster site activation• Allows online monitor review prior to visit• Dashboard view of status, to-dos, calendar, etc.• Maintained and supported by the vendor, so no burden to IT

SAVES MONEY • No more paper processing, overnight mail, FTE time, etc.• Web-based, so no more laptops• Shorten trial duration — reduced monitor, advertising, CRO costs• Speed time-to-market — beat competitors, enjoy longer patent protection time

ADDS SECURITY AND CONTROL

• Document locking and protection• Varied user access privileges• Ability to instantly add/remove users from the portal• Detailed record of all portal activity• 21 CFR Part 11 Compliance

C O N F I D E N T I A L4

Sponsor ROI: Clinical Portals

For sponsors, just getting to “FIRST PATIENT FIRST VISIT” for a Phase III study takes 22 weeks and $5.1M.

Projected industry spend in 2009: $8.8B** Based on the projected number of new Phase III and studies in 2009 of 1,725

With IntraLinks, sponsors can save 10 weeks and $2.1M savings per study.

Projected industry cost savings: $3.6B** Based on the projected number of new Phase III studies in 2009 of 1,725

Assumptions:75-site, 29-month studyA clinical trial costs $36K/day

6 Weeks$1.1 Million

16 Weeks$4 Million

104 Weeks$28 Million

Old Way

2 Weeks$.5 Million

10 Weeks$2.5 Million

IntraLinks Solution

Conduct StudySite Recruitment Study Start-up Close-Out

C O N F I D E N T I A L5

Sponsor ROI: Safety Document Distribution via a Portal

1.5M safety packages/year

Overnight mail: $20/packagePrinting: $.06/page

1-2 business days for each overnight safety package

75,000 man hours (37.5 FTE)/year to execute 1.5M safety packages

No overnight mail or printing costs – simply post the safety document to IntraLinks

No time delay – Instant, simultaneous distribution of safety document via IntraLinks

566 man hours (28% of one FTE)/year to execute 1.5M SAE report distributions)

$30.1M/year

1-2 days/distribution

74,434 man hrs/year

Cost Savings

Time Savings

Human Resource Savings

Old Way IntraLinks Way

Based on sample industry data

C O N F I D E N T I A L6

The Importance of Site Acceptance, Adoption and Use of a Portal • The value of a portal is directly

correlated to site adoption and use

• Lack of, or partial, site adoption and use leads to:

• Running the trial using multiple communication methods: portal, hard copy, email, etc.

• Portal reporting loses value because it does not include all data

• Portal status and completion dashboard will be incomplete because it does not include all sites

• Time is not saved, and processes may even take longer

• Money is not saved, and processes may even cost more

SponsorClinical Trial Portal

C O N F I D E N T I A L7

Why Sites Hate Portals: The Challenges

CHALLEGE REASONIts An Additional System • Sponsors with their own proprietary portals do not eliminate a system

from the site’s world, they add one• Perpetuates the issue of having a different system for every trial• Have to remember another set of credentials

Its Technology • Site personnel are hired for their clinical skills and medical/research experience, not computer skills — the level of tech savvy varies widely

• Requires taking time out of their day to receive training• Have to remember yet another technology interface, not common

across trials or sponsors

Its Not a Priority • Site personnel are in their profession to help people and provide patient care, not to spend time at a computer

Don’t See Direct Value • Portals are seen as providing value to the sponsor, not to the site (no time or money savings realized by the site)

C O N F I D E N T I A L8

Why Sites Love Portals: The Benefits

BENEFIT REASONEliminates Paper • No more copying, mailing and filing

• Reduces or eliminates paper storage in the office

Easy Access to Information • Immediate, online access to most recent versions of documents• Site dashboard provides a quick view of what SSU documents are

outstanding, requests and questions, calendar• On-demand training is available 24/7/365

Reduces Administrative Time • Intuitive, easy-to-use interface streamlines the process and communication with sponsors, allowing site personnel to focus on patient care

• Vendor maintenance and support eliminates the burden from the site

Reduces Complexity • A neutral portal used across sponsors and trials eliminates multiple systems, interfaces, training and credentials

C O N F I D E N T I A L9

The Site Perspective — Too Many Systems

The majority of sites work with more than one sponsor on five or more clinical trials*

This requires sites to access numerous systems and manage a burdensome number of credentials

SITE

* Source: IntraLinks Investigator Site Survey (N=252), March 2009

CROIRB

Sponsor “A” Portal SSO for all Sponsor A clinical trial systems

Sponsor “B” IVRSSponsor “B” EDCSponsor “B” Safety

Sponsor “C” PortalSSO for all Sponsor A clinical trial systems

CRO IVRSCRO EDCCRO Safety

IRB Portal

C O N F I D E N T I A L10

The Site Perspective — IntraLinks

With IntraLinks, sites manage one credential to access a single clinical trial portal for all of their studies, across all sponsors

* Source: IntraLinks Investigator Site Survey (N=252), March 2009

SITE

CROIRB

C O N F I D E N T I A L11

C O N F I D E N T I A L12

The Sponsor Perspective — IntraLinks

With IntraLinks, sponsors have a consolidated configurable view of all studies

* Source: IntraLinks Investigator Site Survey (N=252), March 2009

Study A

Study B

Study C

Study D

Study…n

Global Safety Reports

C O N F I D E N T I A L13

C O N F I D E N T I A L14

Clinical Portal ROI to Sites

• Cost savings

– Reduction in paper processing, storage and maintenance

– Shorter on-site monitor visits

– Reduced FTE time spent on trial administrative duties – reduced disruption

• Benefits

– Explore new treatments and/or provide greater service to patients

– Strengthen relationship with sponsor and build reputation in the trial community

– Publications

– Revenue support

– Opportunity for PI and trainees to learn and expand skills

– Gain experience and credentials that could lead to grant funding and investigator-initiated ventures

C O N F I D E N T I A L15

Top 10 Things to Consider in Selecting a Clinical Trial Portal1. Web-based • Online access anytime, anywhere

2. Secure • Application, infrastructure, process & personnel security

3. Compliant • 21 CFR Part 11• SAS 70 Type II

4. Easy-to-use • Familiar interface• Intuitive

5. Fully Supported • 24/7/365 live global support • Multiple languages

6. Neutral • Not tied to any one sponsor or CRO• Not tied to other services

7. Integrated • Ability to integrate with backend systems

8. Experienced • Experienced and established software provider• Proven track record of technology excellence

9. Global • Global experience, presence and infrastructure

10. Dedicated • Has the ability to invest and scale• Listens to the market, has a vision for the future

C O N F I D E N T I A L16

Q&A — Thank you

Alison ShurellVice President, Product Marketing

EMAIL: ashurell@intralinks.com

PHONE: 212.342.7634

BLOG: http://blog.intralinks.com/AShurell

WEBSITE: www.intralinks.com