An FDA 2020 report (1) has shown a 28% decrease in underrepresented populations in United States clinical trials compared to 2018. Moreover, the 2022 FDA guidance for the industry to improve underrepresented racial and ethnic participants’ enrollment is a call to action to get clinical data that really reflects the diversity of the population expected… Continue reading Rising Equity in Clinical Trials and Emerging Countries Through Tech
Last week we joined the Clinical Research Insider Summit in Cancun, Mexico. This was Integra It’s first time participating in this event, endorsed by the School of Medicine and Health Sciences of Monterrey Tech. As part of our strategy of bringing more visibility to clinical trials in emerging markets, we wanted to explore the future… Continue reading Event recap: Highlights from Clinical Research Insider Summit 2023
Recently, we started a new polio vaccine clinical trial in the Dominican Republic with FIDEC (Fighting Infectious Diseases in Emerging Countries). This initiative is close to our hearts because it addresses infectious diseases affecting vulnerable children. In this interview with Gabriela Aguirre, FIDEC Project Manager, she details the projects and her experience working with… Continue reading Video: FIDEC Success Study Case
Vaccine clinical trials are very complex, around 12 years are needed between Phase I and Phase III studies until a license can be achieved, and the investment can be up to tens of millions of dollars. Another complexity is recruiting hundreds or even thousands of healthy subjects or subjects under specific demographic conditions; this increases… Continue reading Three Ways Tech can Enhance Vaccine Clinical Trials Operations.
In recent years, sites have increasingly invested in technology to eliminate paper records and reduce workloads related to inputting data, scanning, and transcription. Even though they can get huge advantages such as accelerated timelines and workflows, concerns like interoperability, adoption, and staff education remain. Sites can get advantages of tools like structured EMR data to… Continue reading Seven Opportunities for Non-digitalized Sites in 2023
Investigator-Initiated Studies (IIS) are studies where an individual investigator, a research site, or a group of research sites carry out the research from the protocol design until regulatory submission. This means they perform both roles, as a sponsor and as an investigator. This type of clinical research also has been known as investigator-initiated trials, independent… Continue reading Investigator-Initiated Studies, IIS: An Opportunity for Research Sites
ePRO/eCOA Capabilities to better conduct Clinical Studies ePRO/eCOA tools have revolutionized the clinical research industry. The first concept was raised a decade ago, but the idea of integrations between systems or interoperability was far from easy. In the past three years, the industry has experienced a boom of new technology development, broadening the data source… Continue reading Seven ePRO/eCOA Capabilities to Better Conduct Clinical Studies in Latin America
Cybersecurity: Critical in Clínical Trials In recent years, the number of cyberattacks has increased due to the proliferation of viruses, malware, and new and increasingly sophisticated techniques. Therefore, all companies face risks that endanger their systems and can leave confidential information exposed. Still, unfortunately, not all organizations are aware of the risk they face, which… Continue reading Importance of Pentesting in Software used in Clinical Studies
Computer System Validation is a premise for Integra IT to ensure that data and solutions are reliable; validating all of our solutions is one of our core activities and our central quality promise. Since 2002, the FDA has stated the General Principles of Software Validation, guidelines applicable to medical device software validation. The main goal… Continue reading Computer System Validation (CSV) in Clinical Trials
Integra IT understands and has the solution to an issue commonly faced by healthcare systems and clinical trials around the world: interoperability. Seamless integration between information systems in healthcare and clinical research must solve two problems; first, technical interoperability, which means that systems can reliably transfer data between them, and second, semantic interoperability, in which… Continue reading Achieving Interoperability between clinical trials software
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