Ensuring Sponsor and Site ROI from Portal Implementation Alison Shurell – VP, Product Marketing, IntraLinks NOVEMBER 2009

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

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

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

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

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

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

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 study A 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 Study Site Recruitment Study Start-up Close-Out

6 Weeks

$1.1 Million

16 Weeks

$4 Million

104 Weeks

$28 Million

2 Weeks

$.5 Million

10 Weeks

$2.5 Million

Sponsor ROI: Safety Document Distribution via a Portal 1.5M safety packages/year Overnight mail: $20/package Printing: $.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

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 Sponsor Clinical Trial 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

Why Sites Hate Portals: The Challenges CHALLEGE REASON Its 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)

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

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

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

Portals are seen as providing value to the sponsor, not to the site (no time or money savings realized by the site)

Why Sites Love Portals: The Benefits BENEFIT REASON Eliminates 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

No more copying, mailing and filing

Reduces or eliminates paper storage in the office

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

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

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

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 * Source: IntraLinks Investigator Site Survey (N=252), March 2009 CRO IRB Sponsor “A” Portal SSO for all Sponsor A clinical trial systems Sponsor “B” IVRS Sponsor “B” EDC Sponsor “B” Safety Sponsor “C” Portal SSO for all Sponsor A clinical trial systems CRO IVRS CRO EDC CRO Safety IRB Portal SITE

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

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 CRO IRB SITE

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

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

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

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

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

Top 10 Things to Consider in Selecting a Clinical Trial Portal 1. 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

Online access anytime, anywhere

Application, infrastructure, process & personnel security

21 CFR Part 11

SAS 70 Type II

Familiar interface

Intuitive

24/7/365 live global support

Multiple languages

Not tied to any one sponsor or CRO

Not tied to other services

Ability to integrate with backend systems

Experienced and established software provider

Proven track record of technology excellence

Global experience, presence and infrastructure

Has the ability to invest and scale

Listens to the market, has a vision for the future

Q&A — Thank you Alison Shurell Vice President, Product Marketing EMAIL: [email_address] PHONE: 212.342.7634 BLOG: http://blog.intralinks.com/AShurell WEBSITE: www.intralinks.com

Alison Shurell Vice President, Product Marketing

EMAIL: [email_address]

PHONE: 212.342.7634

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

WEBSITE: www.intralinks.com