Cognizant, the SIP Product Owner, has worked to significantly enhance existing capabilities in the SIP platform includin
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Q4 2017 HIGHLIGHTS TransCelerate aspires for a future state where research and development is faster, more efficient, and harnesses all the available information. We envision this happening in 3 ways: 1. Full participation across all stakeholders 2. Information is fully used to improve the overall quality, design and development process. We protect patients through shared, proactive safety science 3. Improving the execution of research and development through greater harmonization with the potential to conduct collaborative trials Common Protocol Template Implementation Materials eConsent Landscape & Implementation Materials Clinical Research Access & Information Exchange Educational Materials
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THE PULSE ON PROGRESS
INFORMATION SHARING & HARMONIZATION SUBCOMMITTEE overview video:
OBJECTIVES: • Utilize existing data sources & information • Design & enable end-toend data flow • Enable collaborative trials
• Since May 2017, the Common Protocol Template (CPT) Initiative has worked to collect feedback to further improve the utility and sustainability of the template in alignment with the Protocol Template developed by the National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA). As a result, Version 5.0 of the Common Protocol Template is now available: http://bit. ly/1YfpRzf. This update includes five new therapeutic libraries, as well as content changes such as contraceptive and barrier language and support for disclosure data uploads into clinical trial registries.
• The Clinical Research Access & Information Exchange Initiative led a series of interactive design workshops to co-create its Clinical Trial Registry of the Future proposal and concept in partnership with patients. The proposal illustrates the challenges patients, their family members and healthcare professionals face when interacting and understanding the vast clinical research information available through government-sponsored registries. To read through the proposed improvements, read more here and share your feedback. • On the journey to digitally supported, patient-centric clinical supply chains, TransCelerate’s eLabels Initiative released its Design & Delivery Toolkit to facilitate voluntary, modular adoption of eLabels and to assist with Health Authority Engagment.
Q4 2017 HIGHLIGHTS
PATIENTS SUBCOMMITTEE overview video:
OBJECTIVES: • Increased awareness & access of clinical research • A better informed patient • Decreased patient burden
THE PULSE ON PROGRESS
SITES SUBCOMMITTEE overview video:
OBJECTIVES: • Enhance site access, visibility, and education • Improve communication between sites and sponsors • Decrease burden of site participation
• In the newest “Site Capabilities Made Simple with SIP” video explainer, we explore the benefits of sharing and reusing site user and facility profile data through the Shared Investigator Platform (SIP). TransCelerate Member Companies, in collaboration with Cognizant, the SIP Product Owner, has worked to significantly enhance existing capabilities in the SIP platform including document exchange. Today there are over 2,000 users on the platform, across 58 countries! Stay tuned for more.
• The RBM Initiative held an Open House to provide an opportunity for experts across sponsor companies and the CRO Forum to network, share lessons learned and best practices, and lay the foundation for future collaborative opportunities. It is clear that interest in the RBM methodology and framework continues to grow and evolve. Thanks to all who made this Open House possible! • A third eSource Roundtable was held in conjunction with an HL7 Connectathon and HL7 Working Group in New Orleans, LA. and assembled key industry leaders in a collaborative effort to move the needle on the use of eSource data and system interoperability in clinical trials. The meeting included: –– Discussion of the importance of collaborating on the development of standards and standardization across healthcare and clinical research. –– Exploration on how TransCelerate, HL7, and other organizations can help facilitate the key required industry shifts to increase the scalability and testing from demonstration projects to the broader use of eSource in clinical research as part of normal business operations.
Q4 2017 HIGHLIGHTS
SPONSORS SUBCOMMITTEE overview video:
OBJECTIVES: • Foster data privacy, reliability & integrity • Promote efficient internal trial delivery
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