C26: Shared Investigator Platform (SIP) Overview

PUTTING PATIENTS AT THE CENTRE OF HEALTHCARE #ARCSAUS

C26: Shared Investigator Platform (SIP) Overview

Speaker: Toni Hopkins, MSD

Copyright ©2018 TransCelerate BioPharma Inc., All rights reserved. 2

Our Shared Vision:

To improve the health of people around

the world by accelerating and simplifying

the research and development of

innovative new therapies.

TransCelerate:

A Not-for-Profit Entity Created to Foster Collaboration

Copyright ©2018 TransCelerate BioPharma Inc., All rights reserved.

2 0 MEMBER

COMPANIES

Current state of organization

Today

25+including 4

pharmacovigilance initiatives

INITIATIVES

focus on preclinical research

ENHANCING INDUSTRY

COLLABORATION

With an effective and

proven governance

structure have increased the

ease and desire to collaborate

FACILITATING

FUTURE PLATFORM TRIALS

12+ initiatives deliver solutions that facilitate future platform

trials

BREADTH &

DEPTH

Over 30 solutions

being delivered across 25+

initiatives, across 3

strategic priorities

TransCelerate Founded

2012

5 INITIAL

INITIATIVES

10 MEMBER

COMPANIES

3

platform to enable data sharing

BioCelerate Founded

2016

Regeneron most recent member


The Reach of our Global Membership is Expanding

4

There are

over

peoplefrom Member Companies that

design and develop

TransCelerate solutions.

Membership is available to biopharmaceutical research and development organizations

that engage in innovative discovery, development and manufacturing of new medicines*.

* to be eligible for membership, companies must meet

specified eligibility criteria.

SIP Concept


Moving the Needle: TransCelerate Initiatives

6

Reduce the burden on investigative sites

by providing them with a central point

of access, harmonized content and services, and streamlined interaction

with participating clinical trial Sponsors.

Establish a voluntary registry for consenting investigators. Providing a

global collaborative image that will be

beneficial for clinical trial efficiency and

productivity.


SIP Vision

7

Ce

ntr

al Po

int

of

Ac

ce

ssH

arm

on

ize

d C

on

ten

t

Reuse of Data

SIP Functionality

and Benefits


SIP Delivered Roadmap

9

The Shared Investigator Platform - developed With Sites, For Sites

Release 1(Jan 2016)

✓ Single Sign On

✓ User Profile

✓ Facility Profile

✓ Training

✓ Feasibility Surveys

✓ Study Workspace

✓ Document Exchange

✓ Tasks, Alerts & Notifications

✓ Dashboards and Reporting

Release 2(Aug 2017)

✓ Document Management (e.g., versioning, workflow, e-signatures, Integration to sponsor eTMF

✓ Safety Letters

✓ Enhanced functionality

✓ Expanded Reporting

✓ Usability enhancements

Release 3(Mar 2019)

✓ Enable Onboarding at Scale

✓ Migration ongoing studies

✓ Bulk registration

✓ Centralized Workflows

✓ Site Networks, Large Univ/Hospitals, SMO, ARO

✓ Investigator Payments


Pre-Study Selection Benefits: Single sign-on, Re-use of

Site User Profiles Information

10

Process

without SIP

Process

with SIP

Log onto multiple portals

with varying processes for

different Sponsors

Completion of CV

information in various

formats for each Sponsor

Log onto one Platform to

collaborate in a harmonized way

with participating Sponsors

Benefit: Complete User Profile once

and maintain to auto-generate a

standardized CV and reuse for

producing an e-1572

~1-2 hours to complete the User Profile and enable re-use across Platform

Several hours to provide redundant profile information for each study and Sponsor


Facility profile

▪ Do you have a -70° freezer?

▪ How long are your IRB turnaround times?

▪ Do you have a monitoring system for cold

storage?

▪ How frequently does your IRB meet?

▪ Do you have an X-ray?

▪ …..

50% less

questions

Feasibility survey

8 Number of Calendar Days, on average, a feasibility survey is

completed, shortening Site ID Timelines

Re-use of Facility Profile data to streamline completion

of Feasibility Survey and Study Site details


Today – Combined Solution Value to Investigators

Your

Colleagues

are Realizing

this Value!

PROFILE

DATA

TRANSPARENCY

ACCESS

DATA TRANSPARENCY

Investigators can add a comment to a study

record to put the enrollment metrics into context from a defined

set of options

Showing investigators their own data

demystifies what data is being shared

Investigator can create, view their own study history across sponsors, including enrollment metrics, and edit profile

Expand access to research opportunities by making investigators/sites known to more sponsors

ACCESS

PROFILE


Today – What Sites are Saying

“SIP is the right way in leading sponsors and

investigators to work together on important,

required steps in the set up process, which results in less paperwork and less

unnecessary / duplicate steps in their

collaboration with various sponsors, and

most importantly, more time for the

patients.”- Investigator in Greece

“I had a very positive experience with

setting up my profile and answering the

surveys in SIP. I believe this is the future way

of working.”- Investigator in France


Today – We Hear You – Re-Use of Information

How SIP meets your requests:

• Sites can re-use their Facility

Profile information to pre-

populate parts of the

Feasibility Survey, reducing

time needed to complete

the survey

• Investigators can delegate

the completion of Feasibility

Surveys to central offices of

Site Networks, AROs, and

SMOs, while having the ability to directly review and make

changes to their information.

Feasibility is taking

way too much time–

we need a way to

reuse our

information, but also

to use the central

office to manage

feasibility surveys on

our behalf.

-Sites

Once SIP supports our

ability to receive these

types of contacts

(invitations, surveys, etc)

on investigators’ behalf,

we’ll be able to help them

conduct their studies in

the system.

-Site Network Organization


Post- Study Selection Benefits: Mutual Recognition

Training (MRT) Program

15

Process

without SIP

Process

with SIP

Investigator must complete GCP

Training for each Sponsor

Site User submits MRT

Request to Sponsor

Sponsor can accept

MRT request

Site User may receive GCP Training Credit

without having to repeat training

Site User completes a GCP Training

under MRT Program

Sponsor 1 Sponsor 2 Sponsor 3

Training

Certificate


Value Proposition

16

Reduce risk

with Site as

source of

info

Improved

relationships

Globalize

processes Save time

and effort

Active

listening and

responding

Harmonizatio

n of delivery

of content

and services

Reduce

administrative

burden and

duplication

Recognized as

a leader and

innovator in

the industry

SPONSORS

SITES

Current SIP

Journey and

Implementation


Current Global Usage

18

❖ 6 Sponsors are live on the Platform

❖ 28,695 Registered Site Users

❖ 10,940 Sponsor Users

❖ 81 Countries

❖ 269 Studies Created

❖ 1,008 Site Personnel >1 Study

❖ 91 Investigators > 1 Sponsor

*as of 29 July 2019


SIP Adoption—Australia

19

Oceania 758

American Samoa 1

Australia 584

New Zealand 173

*as of 29 July 2019

SIP Registered Site Users in Oceania Region


SIP Journey

20

Q1 2016SIP Release 1.01st Member Company Adoption

Q4 2016 – Q1 2017Releases 1.1 – 1.32nd and 3rd Member Company Adoptions

Q3 2017 – Q1 2018Releases 2.0 and 2.14th Member Company Adoption

Q3 2018- Q1 2019Releases 3.0- 3.12 Additional Member Company Adoptions expected.SIP Core Product Requirements are fulfilled.5th Member Company Adoption

Q2-Q3 2019Implementation of Governance strategy and transition plan. 6th Member Company Adoption

Q4 2019

Release 4.0

SIP User Group Launched

2020 and beyondTransition is complete and Cognizant is the sole owner of SIP.

Thank you

Documents

C26: Shared Investigator Platform (SIP) Overview