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Is all the talk about machine learning for clinical trials for real, or is it just hype?

What is CTMS? 

It was a challenging year in the life sciences industry, but there are numerous key takeaways from clinical trials and clinical research in 2020. 

After a paradigm shifting year for clinical research, what do industry experts anticipate for clinical trials in 2021?

How does the pandemic changed the way we prepare for TMF inspections, and how do we address the new challenges remote inspections could bring?

The Hidden Costs of Cheap Translation

Medical literature review at a local level has always been a challenge. Is technology the answer to simplifying the process?

The beginning of November saw the launch of version 3.2.0 of the TMF Reference Model. The updates align with current regulatory guidance and industry best practices, making it easier to organize the TMF Reference Model to suit a company’s own processes.

Technology Virtual Summit: Content Solutions for MDR & IVDR Readiness

While all TMF documents are important, some are more crucial to a trial than others. At the core of these are the essential documents, as defined by ICH Guideline for Good Clinical Practice, E6, Section 8, “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.”