TransCelerate BioPharma Inc.
Membership Application
Applicant Information
Company Name
Primary Company Contact
Address
City
State
Zip
Email
Phone
Fax
Membership Class Requested
Eligibility for membership in a particular class is based on the applicant’s publicly available annual budget
for research and development over the three years preceding the date of the application and additional
criteria included in the TransCelerate BioPharma Inc. (“TransCelerate”) bylaws.
☐ Tier 1 Member ________________ (Annual R&D budget in excess of $2.5 Billion)
☐ Tier 2 Member ________________ (Annual R&D budget over $100 million but less than $2.5 billion)
☐ Associate Member ________________ (Annual R&D budget of less than $100 million)
Dues
Member dues are established by the TransCelerate Board of Directors on an annual basis and vary
based on membership class (above). Members may also be subject to special project assessments.
TransCelerate BioPharma Inc. Membership Application
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TransCelerate Project Areas
Based upon the Applicant’s interest, please prioritize the particular TransCelerate projects (rank 1 through
5):
☐ Shared Site Collaboration Platform
A shared, cross-industry site investigator portal designed to streamline investigator and site
access through harmonized delivery of content and services. The Portal will offer a central point
of access and single sign on for investigators and site staff.
☐ Risk Based Monitoring
Develop an industry-wide standard and approach for risk-based monitoring of clinical trials in
order to enhance patient safety and ensure the quality of clinical trial data.
☐ Clinical Data Standards
Partnership with the Clinical Standards Data Interchange Consortium to develop industry-wide
data Standards in priority therapeutic areas to support the exchange and submission of clinical
research and meta-data, improving patient safety and outcomes.
☐ Site Qualification & Training
Agreements established for mutual recognition of Good Clinical Practice training and site
qualification credentials in order to realize efficiencies and accelerate study start-up timelines.
☐ Comparator Drug Supply
Establish reliable, rapid sourcing of quality products for use in clinical trials through a comparator
supply model enabling accelerated trial timelines and enhanced patient safety.
☐Common Protocol Templates
Standardize the format of clinical protocols to ease interpretation & enable down-stream
automation of many clinical processes. Develop industry-wide & regulator accepted standard for
required protocol endpoints per therapeutic area.
☐Special Populations Investigator Network
Lead the development of global investigator networks for pediatric and minority populations
including governance, investigator and patient registries, and technical infrastructure.
TransCelerate BioPharma Inc. Membership Application
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☐Investigator Registry
Create a shared repository of investigator contact details, training/qualification assessment, and
performance data across companies to support targeted site selection.
Applicant Acknowledgment
The Applicant acknowledges that the following terms and conditions apply to this Application and
TransCelerate membership:

The Application is subject to acceptance by the Board of Directors, including verification of the
Applicant’s eligibility for membership in a particular class.

Upon acceptance of the Application, the Applicant will become a TransCelerate member only
upon (i) execution of the TransCelerate Membership Agreement (copy attached) and (ii)
payment of initial and annual dues.

The Applicant agrees to be bound by the terms of the TransCelerate Articles of Incorporation,
Bylaws and the policies which the TransCelerate Board of Directors may, from time to time,
adopt.
Signature of Applicant’s Authorized Representative
_________________________________
Name:____________________________
Title:_____________________________
Date:_____________________________
Please submit the completed application to Sarah Plush, sarah.plush@transceleratebiopharmainc.com.