pulse progress on - transcelerate...we’re undertaking new and expanded initiatives in 2019 to help...
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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 three ways:
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We’re undertaking new and expanded initiatives in 2019 to help fulfill our goals of accelerating and simplifying the drug development process! The expanded clinical and drug portfolio now includes the Common Serious Adverse Events (SAE) Fields Initiative workstream, the Modernization of Statistical Analytics Initiative and an expansion in scope of Interpretation of Guidance and Regulations (IGR) to include both pharmacovigilance and clinical guidances. For its first deliverable, the IGR workstream is creating a Quality Tolerance Limits Framework to help improve clinical compliance.
Q1 2019 HIGHLIGHTS
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
Q1 2019 HIGHLIGHTS
THE PULSE ON PROGRESS
Information Sharing & Harmonization
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 eSource Initiative developed the Site Capability Questionnaire, intended to help capture sites’ use of technology during the site qualification process. The form aims to facilitate the reduction of administrative burden on investigative sites by collecting information consistently across multiple sponsor companies.
Q1 2019 HIGHLIGHTS
THE PULSE ON PROGRESS
Improve the Patient & Site Experience
Improve the patient and site experience by decreasing burden, enabling a better-informed patient and improving clinical research awareness, participation & engagement.
• The Patient Technology (PT) Initiative released two new resources, including the Patient Technology Implementation Framework and the Regulatory Landscape Tool. The Implementation Framework is designed to help sponsors develop holistic approaches for the application of patient-facing digital technology, while also encouraging a mindset of strategic thinking, rapid learning and patient-centric design. The Regulatory Landscape Tool presents an overview of U.S. and E.U. regulatory requirements related to PT and their use in clinical trials. It also provides links to relevant regulations, guidance and intelligence addressing these topics. Both resources are available now on the PT Assets page.
• The Quality Management System (QMS) team announced the release of two new manuscripts published in Therapeutic Innovation & Regulatory Sciences (TIRS). These papers provide insightful guidance for implementing QMS Risk Management and QMS Process Management frameworks in clinical development. In addition, they are each accompanied by several supporting tools to further assist in the implementation process:
» Risk Management Risk Library aids sponsors in the development and execution of a risk library for their organizations.
» Interactive Toolkit for Implementing Processes provides further instruction, examples and templates to help support the practical application of a Processes framework.
Q1 2019 HIGHLIGHTS
THE PULSE ON PROGRESS
Improve the Patient & Site Experience continued
• The eConsent team updated their global metrics based on the eConsent Global Landscape Survey. On the interactive map, users can view which countries have had eConsent submissions (to HAs and/or IRB/IECs), and which of those countries actively consented patients using eConsent. Visit our eConsent Assets page to learn more.
• The Shared Investigator Platform (SIP) has released R3.1. This release is the last co-developed release with Cognizant and completes the initiative’s development objectives. R3.1 includes:
» Expanded, centralized workflows to onboard & collaborate with Site Networks, SMOs, AROs & CROs
» Introduced open, public APIs for Payments Module integration
» Delivered 100% of open items from previous releases and no remaining open defects
• Due to feedback gathered by the Site Qualification and Training (SQT) Initiative on multiple SQT forms, the team has developed unlocked Word versions of both the current CV template and the Financial Disclosure Form. Download these helpful resources on our website.
Q1 2019 HIGHLIGHTS
THE PULSE ON PROGRESS
Enhance Sponsor Efficiencies & Drug Safety
Facilitate the advancement of innovative healthcare and clinical research through improved technologies, advanced data collection systems and simplified processes.
• The Risk-Based Monitoring Initiative enhanced the Risk Indicator Library published in 2015. The refreshed library refined and removed several key risk indicators based on feedback that suggested the existing format and structure needed updating and simplification.
Have Questions?
Please direct all inquiries as specified below:
Learn more about our Initiatives through our video overviews:
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General:[email protected]
Site Training & Qualification:[email protected]
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BioCelerate Updates: http://transceleratebiopharmainc.com/biocelerate/