The Pulse on Progress
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:
- Full participation across all stakeholders – clinical trial sponsors, sites, investigators, patients and their healthcare providers
- Information is fully used to improve the overall quality, design and development process. We protect patients through shared, proactive safety science
- Improving the execution of research and development through greater harmonization with the potential to conduct collaborative trials
Information Sharing & Harmonization
- The TransCelerate eSource Advancement Roundtables are intended to assemble industry leaders in a collaborative effort to move the needle on the use of eSource data and interoperability in clinical research. Decision makers and influencers from Consortia, CROs, Health Authorities, Sites, Standard Setting Bodies (HL7, CDISC, SCDM etc.), Sponsors and Technologists are encouraged to attend. Upcoming Roundtables include:
- eSource Advancement Roundtable: The Future of Clinical Trial Data Flow & The Influence of the Protocol on Data Collection on June 28 at the DIA Annual Meeting.
- eSource Advancement Roundtable: Unstructured Data, Devices & Apps on September 28 at an HL7 Connectathon.
- The Common Protocol Template Initiative has issued translated versions of the Basic Word Edition Core Template and Patient Library now available in Japanese.
Improve the Patient & Site Experience
- The Clinical Research Awareness Initiative unveiled a new global campaign designed to help increase awareness of the growing need for clinical trial participants. The campaign, called “One Person Closer,” focuses on inspiring healthcare professionals (HCPs) to consider clinical research as a possibility for their patients, incorporate the topic into their daily practices, and have meaningful conversations with patients about opportunities to participate in clinical trials. The campaign includes video vignettes of 12 patients, researchers, and healthcare professionals sharing their stories. To join the conversation visit the campaign on Facebook at https://www.facebook.com/onepersoncloser and follow One Person Closer on Twitter at https://twitter.com/onepersoncloser.
- The Shared Investigator Platform (SIP) Initiative achieved Release 2.1, the most complicated release delivered to date. This release introduced critical functionality and key benefits including Document Exchange and Safety Notifications (via SAFE-D integration) as well as significant enhancements and updates to existing functionality. We are excited to see the global momentum as SIP is now active in 58 countries and 25,000+ projected users by year end.
- A variety of Site Qualification & Training forms, templates and video trainings have been translated into Japanese and Mandarin for broader use in the global community.
Enhance Sponsor Efficiencies & Drug Safety
- The Interpretation of Pharmacovigilance Regulations Initiative participated in a workshop titled, “Public Workshop: Safety Assessment for Investigational New Drug Safety Reporting,” with the Food and Drug Administration focused around key challenges and best practices for prospective designation of expected and anticipated adverse reactions and systematic approaches for predicting the rates of such events.
- The Value of Safety Information Data Sources Initiative presented their hypothesis at the DIA Pharmacovigilance conference in January 2018 around the value of data from patient support programs, market research and social media which concluded that these sources are of low value and have not led to label changes or opportunities to better understand safety profiles. The Initiative will continue to engage with Health Authorities on potential recommendations.