TransCelerate Launches Three New Initiatives


Applied Clinical Trials

TransCelerate Launches Three New Initiatives TransCelerate BioPharma Inc., a non-profit, announced it has committed to an expansion of its clinical and drug safety portfolio, revealing the following new initiatives:

  • The Common Clinical Serious Adverse Events (SAE) Fields Initiative intends to conduct a feasibility assessment, develop best practices relating to identifying the most critical SAE fields, and work with an industry standard setting organization to promulgate standards in this area, all with the intent of increasing the quality of what is reported and creating efficiencies for sites, CROs and regulators.

  • The Modernization of Data Analytics for Clinical Development Initiative aims to analyze methods for considering and validating novel statistical computing platforms to propose to Health Authorities and better enable them to support these platforms.

  • Due to the success of the Interpretation of Guidances and Regulations Initiative launched in drug safety in 2018, the initiative has expanded in scope from strictly pharmacovigilance to include clinical guidances and regulations. For its first deliverable, the workstream is creating a Quality Tolerance Limits Framework to help facilitate clinical trial compliance. The framework will propose interpretations of clinical regulations and seek to foster harmonization across health authorities by proactively sharing recommendations that reduce the amount of duplicative efforts and audit findings.

“These three new initiatives are fully aligned with our strategic priorities and future roadmap. We expect these deliverables to enhance our prior investments and to deliver quick and tangible value to our members and other stakeholders,” said Janice Chang, Executive Vice President, TransCelerate BioPharma Inc. “Furthermore, as multiple stakeholders adopt our work globally, we have significantly ramped up our engagement with health authorities who are increasingly eager to collaborate with TransCelerate to solve common problems. Broader global adoption of our work is complemented by Member Company networks in over 30 countries that apply regional, cultural and regulatory implications to our initiatives.”

Echoing Ms. Chang’s sentiment, Badhri Srinivasan, Head, Global Development Operations, Novartis noted, “One of the strengths of TransCelerate is that it engages key groups across the Research and Development landscape to find opportunities for streamlining. This includes getting the right input from patients, investigative sites, academic researchers, clinical research organizations and health authorities to incorporate into collaborative approaches. Since joining TransCelerate less than two years ago, we have been very active contributors in multiple successful initiatives as well as adopting a number of solutions.”

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