On June 26, 2024, the FDA issued new draft guidance describing the format and content, medical products, clinical studies, timing, and process for submitting diversity action plans. Likewise, the criteria and process by which the FDA will evaluate sponsors’ requests for exemption from this requirement. This guidance is a response to the FDORA Act… Continue reading 2024 FDA Draft Guidance on Diversity Action Plans: Enhancing Inclusion in Clinical Studies
Clinical trial participation is the core of future medical advances. But for sites, recruiting patients in clinical trials and conducting them on the journey is usually a challenging task, driving to nearly 80% of trials failing to meet on-time enrollment (1). In a digital era, technology is at the service of improved trial participation and… Continue reading Six Benefits of Automating the Recruiting Flow in Clinical Trials
Table of Contents In a world where it seems everyone is talking about artificial intelligence, and its numerous benefits, we cannot ignore the fact that artificial intelligence is transforming industries and sectors all over the world and one of them is the pharmaceutical area. Essentially, AI is a robust tool helping to overcome large problems… Continue reading How Artificial Intelligence is Transforming Clinical Trials: The Case of AstraZeneca
Table of Contents This blog provides the immense potential of CRISPR, a revolutionary genome editing tool that is revolutionizing the field of DNA editing. What is CRISPR? CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a gene-editing technology that allows scientists to modify DNA sequences with high precision and efficiency. It is based on a… Continue reading CRISPR: The Promise of Gene Editing in Clinical Trials
Over the years, migration trends have changed, and the United States still has the highest rates of immigrants globally. This reality has impacted public health and healthcare access, demanding legislation and policies such as providing prenatal care to women regarding their immigrant status, which has been adopted in 18 states (1). On the other hand,… Continue reading Remarks On Engaging The Hispanic Community In Clinical Trials, and how technology is helping
The Food and Drug Omnibus Reform Act of 2022 (FDORA) was signed into law, amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. It includes provisions that impact various aspects of the FDA-regulated industry. Some key provisions include reauthorizations of FDA programs, reporting requirements for approved biological products, improvements in… Continue reading Implications of The Food and Drug Omnibus Reform Act of 2022 (FDORA) for the clinical trial industry
We are pleased to announce that we have recently iniciate a significant partnership as technology providers for the CHRISTUS LATAM Clinical Research Center, a research center located in Nuevo León, Mexico, that offers clinical research solutions for the pharmaceutical industry and seeks to provide more treatment options and modern medicines to the Mexican population. … Continue reading CHRISTUS – LATAM and Integra IT Announce Partnership
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
Meet us at these upcoming industry events and learn more about our software ecosystem right hand with the Integra IT experts. March – April 2023 Events March 4th CLINICAL RESEARCH INSIDER SUMMIT Congress / March 23th – 25th Outsourcing In Clinical Trials Southeast 2023 / March 28th – 29th SCRS Diversity Site Solutions Summit 2023… Continue reading Events Calendar March-April 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
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