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—clinical trial sponsors, sites, investigators, patients and their healthcare providers 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 NEWEST RESOURCES PROGRESS PULSE THE ON The Common Protocol Template Initiative announced Release 6.0, which included the Common Statistical Analysis Plan (SAP) and Common Clinical Study Report (CSR) Basic Word Edition templates Patient Technology “Accelerating Adoption of Patient-Facing Technologies in Clinical Trials” Paper Q4 2018 HIGHLIGHTS
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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—clinical trial sponsors, sites, investigators, patients and their healthcare providers
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
NEWEST RESOURCES
PROGRESSPULSETHE
ON
The Common Protocol Template Initiative announced Release 6.0, which included the Common Statistical Analysis Plan (SAP) and Common Clinical Study Report (CSR) Basic Word Edition templatesPatient Technology “Accelerating Adoption of Patient-Facing Technologies in Clinical Trials” Paper
Enable the industry to move toward greater harmonization of process and facilitate the sharing of information amongst industry stakeholders to enable the industry to capture, optimize and experience efficiencies.
• The Common Protocol Template (CPT) Initiative announced Release 6.0 of the CPT. This latest release includes two new Therapeutic Area Libraries for Vaccines and CV-Safety, and alignment with the EU Clinical Trial Regulation analysis, ICH E6 [R2] and E9 [R1]. It also features updates based on feedback from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), more robust statistical content, improved authoring functionality and access to contraceptive related language from libraries. Additionally, the sixth release includes the Common Statistical Analysis Plan (SAP) and Common Clinical Study Report (CSR) Basic Word Edition templates. All refreshed supporting tools and resources are available on the CPT Assets page.
Improve the patient and site experience by decreasing burden, enabling a better-informed patient and improving clinical research awareness, participation & engagement.
• The Patient Technology Initiative recently published a paper in Therapeutic Innovation and Regulatory Science (TIRS), titled, “Accelerating Adoption of Patient-Facing Technologies in Clinical Trials.” In this piece, the initiative team discusses the potential value of patient-facing technologies as a clinical research tool, along with the opportunities, challenges and facilitators associated with their implementation. The article also highlights several proposals for establishing a more holistic, collaborative and strategic approach for the widespread adoption of patient technology in clinical trials.
• The Shared Investigator Platform (SIP) is experiencing exciting growth—over 15,000 site users have now registered on the platform. The registered users represent 78 countries across more than 5,400 facilities, and there are more than 150 active studies in the SIP, today.
Facilitate the advancement of innovative healthcare and clinical research through improved technologies, advanced data collection systems and simplified processes.
• Following the successful meeting at EMA in September, there is work underway to bring the issues around Value of Safety Information Data Sources (VSIDS) to the International Council on Harmonization (ICH). TransCelerate was asked to provide input into a PhRMA & EFPIA joint proposal, which was submitted to ICH in December 2018.
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