1. Introduction to TransCelerate
Date updated
Clinical Content & Reuse
December 2019

2. A Not-for-Profit Entity Created to Foster Collaboration
TransCelerate:
A Not-for-Profit Entity Created to Foster Collaboration
Our Shared Vision:
To improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies.
Legally approved 4-Oct-2018
Many of the TransCelerate assets are available free-of-charge on the TransCelerate website.
Assets such as the Common Protocol Template have more than 6,500 unique downloads from the TransCelerate website.

3. Current state of organization
2012
2016
Today
TransCelerate Founded
BioCelerate Founded
2 0
MEMBER
COMPANIES
25+
including 4 pharmacovigilance initiatives
INITIATIVES 10
MEMBER
COMPANIES
focus on preclinical research
Regeneron most recent member 5
INITIAL INITIATIVES
From PSI Deck June 2019
BREADTH & DEPTH
Over 30 solutions being delivered across 25+ initiatives, across 3 strategic priorities
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
platform to enable data sharing

4. The Reach of our Global Membership is Expanding
Membership is available to biopharmaceutical research and development organizations that engage in innovative discovery, development and manufacturing of new medicines*.
There are
over
1,000
people
from Member Companies that design and develop TransCelerate solutions.
From: Transcelerate Deck PSI Final – June 2019.
TransCelerate itself is only 23 employees. The membership and the experts coming from our member companies are essential to the TransCelerate success – they drive it.
* to be eligible for membership, companies must meet specified eligibility criteria.

5. RESEARCH AND CRO COMMUNITY* PATIENT ADVOCACY GROUPS*
External Collaboration will continue to play a critical role in achieving our future state
CliC
As a single stakeholder organization, we understand the value of robust collaboration with key stakeholders* across the R&D ecosystem which provide unique and important insights and perspectives.
INVESTIGATOR SITES*
RESEARCH AND CRO COMMUNITY*
PATIENT ADVOCACY GROUPS*
FOCUS ON SITES
by launching SCRS Site Advocacy Groups
From PSI Final Deck June 2019
(Speaker Notes Legally approved 8-Apr-2017 for prior versions of this slide)
TransCelerate is well aware that it is part of a very wide healthcare eco-system. It is one thing to develop and design solutions that will benefit the pharma companies, it is another thing to get them adopted more broadly by the industry as a whole. Therefore it is critical for TransCelerate to engage with, and secure feedback from a variety of partners in the industry and regulatory bodies.
Some examples:
TransCelerate has engaged with BIO - BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations to ensure they understand what TransCelerate is trying to accomplish and are aware of TransCelerate’s proposed solutions for the industry.
Secondly, as many of TransCelerate’s solutions are intended to improve efficiency at the study-level, ensuring that Investigator Sites and Clinical Research Organizations are aware of TransCelerate is important. To that end TransCelerate has an agreement with the Society for Clinical Research Sites (SCRS)  establish dedicated Site Advocacy Groups, specifically to participate on TransCelerate workstream.  SCRS is a fast growing global organization created by the investigator community to advocate for the investigator community. SCRS provides TransCelerate direct access to investigative sites in the US, Europe, Latin America and soon China.   Through this newly formalized partnership, TransCelerate's working teams will have direct access to these top sites and investigators to gather timely input/feedback on various workstreams outputs. TransCelerate also engages with CROs through their trade organizations, ACRO and JCROA in Japan.
Finally, TransCelerate recognizes the importance of open lines of communication & dialogue with regulatory bodies / health authorities around the world to ensure their input and guidance is obtained on proposed solutions and that their feedback is taken into account prior to any releases of deliverables. Efforts are ongoing to obtain this important input.
OTHER
ASSOCIATIONS*
HEALTH
AUTHORITIES*
* Representative organizations, not exhaustive

6. TransCelerate’s Initiatives Deliver Practical Solutions to Overcome Inefficiencies in Research & Development
HARMONIZE
PROCESS AND SHARE INFORMATION
IMPROVE THE PATIENT AND SITE EXPERIENCE
Clinical Research Access and Information Exchange
Clinical Research Awareness
eConsent
eLabels
Investigator Registry
Patient Experience
Patient Technology
Site Qualification and Training
Shared Investigator Platform
OUR MISSION:
Collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high- quality delivery of new medicines
Clinical Data Standards
Clinical Content & Reuse (formerly Common Protocol Template)
Comparator Network
DataCelerate®
eSource
Digital Data Flow
Placebo Standard of Care
Toxicology Data Sharing
Common Clinical SAE*
Site/Investigator Experience
From TC Overview deck Aug 2019
ENHANCE SPONSOR EFFICIENCIES & DRUG SAFETY
Advancing Safety Analytics
Clinical Data Transparency
Data Monitoring Committee
Intelligent Automation Opportunities in Pharmacovigilance
Interpretation of Guidance and Regulations*
Modernization of Statistical Analysis*
Protocol Deviations
Quality Management System
Risk-Based Monitoring
Value of Safety Information Data Sources
* New Work approved by TransCelerate Board for 2019

7. Thank you