TransCelerate BioPharma
Non-profit consortium of biopharmaceutical R&D organizations that develops shared, standards-based, patient-centered resources, technical reference implementations, and operational toolkits to simplify and accelerate clinical research. Activities include multi-member initiative development, multi-stakeholder engagement, delivery of implementation toolkits and technical artifacts, and educational programming.
Industries
Nr. of Employees
small (1-50)
TransCelerate BioPharma
Products
Secure clinical data sharing platform (member-access modules)
Access-controlled repository supporting upload, de-identification, harmonization and controlled access to subject-level clinical and toxicology data; includes modules for historical control-arm data and nonclinical toxicology/background control data.
Protocol digitalization artifacts and study-definitions repository
Reference architectures, mapping utilities, a study-definitions repository reference implementation (including source code) and technical artifacts to support automated protocol population and interoperability between authoring and downstream systems.
Clinical template suite and eTemplates
Library of harmonized protocol, SAP and CSR templates, eTemplates and supporting add-ins with installation instructions and prerequisites to enable consistent authoring and downstream automation.
Study participant engagement toolkits
Patient protocol engagement toolkit, study-participant feedback questionnaire toolkit and individual participant data return package comprising templates, guides and presentation materials for patient engagement and participant data return.
Interactive pharmacovigilance automation assessment tool
Interactive tool and accompanying materials that help identify opportunities and benefits for automation across ICSR process steps and visualize automation use cases for pharmacovigilance.
Risk-based monitoring toolset
Suite including a risk-assessment and categorization tool, a library of risk indicators, interactive RBM guides and metrics to implement and measure RBM across studies.
Secure clinical data sharing platform (member-access modules)
Access-controlled repository supporting upload, de-identification, harmonization and controlled access to subject-level clinical and toxicology data; includes modules for historical control-arm data and nonclinical toxicology/background control data.
Protocol digitalization artifacts and study-definitions repository
Reference architectures, mapping utilities, a study-definitions repository reference implementation (including source code) and technical artifacts to support automated protocol population and interoperability between authoring and downstream systems.
Clinical template suite and eTemplates
Library of harmonized protocol, SAP and CSR templates, eTemplates and supporting add-ins with installation instructions and prerequisites to enable consistent authoring and downstream automation.
Study participant engagement toolkits
Patient protocol engagement toolkit, study-participant feedback questionnaire toolkit and individual participant data return package comprising templates, guides and presentation materials for patient engagement and participant data return.
Interactive pharmacovigilance automation assessment tool
Interactive tool and accompanying materials that help identify opportunities and benefits for automation across ICSR process steps and visualize automation use cases for pharmacovigilance.
Risk-based monitoring toolset
Suite including a risk-assessment and categorization tool, a library of risk indicators, interactive RBM guides and metrics to implement and measure RBM across studies.
Services
Facilitates multi-company working groups to design, develop and deliver shared technical solutions, implementation toolkits and stakeholder engagement for clinical R&D challenges.
Community outreach, webinar series, connectathons, workshops and conferences to disseminate solutions, collect implementation feedback, and provide training and case studies.
Provision of downloadable toolkits, templates, interactive tools and guidance documents for adoption and customization by member organizations and implementers.
Facilitates multi-company working groups to design, develop and deliver shared technical solutions, implementation toolkits and stakeholder engagement for clinical R&D challenges.
Community outreach, webinar series, connectathons, workshops and conferences to disseminate solutions, collect implementation feedback, and provide training and case studies.
Provision of downloadable toolkits, templates, interactive tools and guidance documents for adoption and customization by member organizations and implementers.
Expertise Areas
- Clinical trial design and modernization (pragmatic, embedded, decentralized)
- Protocol digitalization and study-definition interoperability
- Healthcare-to-research standards mapping (FHIR to clinical data standards)
- Pharmacovigilance process optimization and ICSR automation
Key Technologies
- HL7 FHIR interoperability
- Study-definition data models and unified study-definition model (USDM)
- Study definitions repository reference implementations and APIs
- Controlled-access, validated data repository modules (21 CFR Part 11 considerations)
News & Updates
Webinar discussing tools and resources for implementing ICH E8 concepts such as critical-to-quality factors, stakeholder engagement and critical thinking for trial design and conduct.
Public informational session on privacy-methodology recommendations to support secondary reuse of clinical trial data across organizations; covers comparability and governance considerations.
Summit participation focusing on advances in clinical trial innovation, including sessions on patient technology, patient experience, real-world data and modernizing clinical trial conduct.
Presentation on pharmacovigilance guidance interpretation and safety-related topics at a global PV and risk-management conference.
Three-week connectathon demonstrating integration and interoperability of applications using a unified study-definition model and exploring technical implementations of digital study definitions.
Participation at a global pharmacovigilance congress, including a keynote session on innovation and future-proofing pharmacovigilance.
Webinar discussing tools and resources for implementing ICH E8 concepts such as critical-to-quality factors, stakeholder engagement and critical thinking for trial design and conduct.
Public informational session on privacy-methodology recommendations to support secondary reuse of clinical trial data across organizations; covers comparability and governance considerations.
Summit participation focusing on advances in clinical trial innovation, including sessions on patient technology, patient experience, real-world data and modernizing clinical trial conduct.
Presentation on pharmacovigilance guidance interpretation and safety-related topics at a global PV and risk-management conference.
Three-week connectathon demonstrating integration and interoperability of applications using a unified study-definition model and exploring technical implementations of digital study definitions.
Participation at a global pharmacovigilance congress, including a keynote session on innovation and future-proofing pharmacovigilance.