1. Introduction to TransCelerate
Date updated
November 2018

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.
from TransCelerate Overview, 08 June 2018

3. Current state of organization
Today
2012
2016 19
MEMBER
COMPANIES
25+
including 4 pharmacovigilance initiatives
INITIATIVES
TransCelerate Founded
BioCelerate Founded 10
MEMBER
COMPANIES
Novartis most recent member
focus on preclinical research 22
Country Network Span 13
Global Regulatory Authorities engaged 5
INITIAL INITIATIVES
From CPT 101 Webinar, 27Sep2018
BREADTH & DEPTH
Over 30 solutions being delivered across 25+ initiatives, across 3 strategic priorities
CULTURE OF 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 Overview, 08 June 2018
* 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
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*
New slide for replacement- from TransCelerate Overview, 08 June 2018
(Speaker Notes Legally approved 8-Apr-2017 for prior version 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
IMPROVE THE PATIENT AND SITE EXPERIENCE
HARMONIZE
PROCESS AND SHARE INFORMATION
Clinical Research Access and Information Exchange
Clinical Research Awareness
eConsent
eLabels
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
Common Protocol Template
Common Statistical Analysis Plan Template*
Comparator Network
DataCelerateTM
eSource
Digital Data Flow*
Investigator Registry
Placebo Standard of Care
Toxicology Data Sharing
Site/Investigator Experience
from TransCelerate Overview, 08 June 2018
ENHANCE SPONSOR EFFICIENCIES & DRUG SAFETY
Advancing Safety Analytics*
Clinical Data Transparency
Data Monitoring Committee*
Intelligent Automation Opportunities in Pharmacovigilance*
Interpretation of Pharmacovigilance Regulations
Protocol Deviations*
Quality Management System
Risk-Based Monitoring
Value of Safety Information Data Sources
* New Initiative launched in 2018

7. Thank you