A New Era for Clinical Trials: The ICH E6(R3) Guideline 2025
Table of Contents The landscape of clinical research is rapidly evolving, and so are the standards that govern it. On January 6, 2025, the ICH E6(R3) Guideline for Good Clinical Practice (GCP) reached Step 4 of the ICH process, marking a significant milestone in promoting more efficient, high-quality, and patient-centric clinical trials. This long-awaited […]
Are You Prioritizing Participant Safety in Your Vaccine Trials?
Participant safety is the top priority in vaccine clinical trials. Effective safety tracking ensures not only regulatory compliance but also better trial outcomes, improved patient retention, and high-quality data. But how can research teams achieve this without increasing the operational burden? Join Our Exclusive Webinar – Tracking Participant Safety in Vaccine Clinical Trials here Date: […]
Integra IT to Exhibit at the European Site Solutions Summit 2025 in Lisbon
We are excited to announce that we will be exhibiting at the European Site Solutions Summit, organized by SCRS, on February 24-25, 2025, in Lisbon, Portugal! This event, known for bringing together research sites, sponsors, and CROs, is the perfect opportunity to discuss how technology solutions can transform clinical trial management. During our […]
Emmes Group Transforms Vaccine Research: Wins Fierce CRO Award 2024
VaxTRIALS, a Clinical Research Organization (CRO) now part of the Emmes Group, has been a major force in advancing vaccine research, particularly in Latin America. Its achievements include: Leading the fight against Polio: VaxTRIALS played a key role in the development of nOPV2, a vaccine that now protects children in more than 35 countries. Driving […]
Integra IT at Global Site Solutions Summit
The Global Site Solutions Summit™ has been committed to being “the site’s meeting.” The Summit provides a unique hub where sites, sponsors, CRO executives, and regulators come together to discuss best practices and ideas while developing strategic partnerships through ideation sessions, workshops, and focus groups. Whether your priority is networking with sponsors and […]
2024 FDA Draft Guidance on Diversity Action Plans: Enhancing Inclusion in Clinical Studies
On June 26, 2024, the FDA issued new draft guidance describing the format and content, medical products, clinical studies, timing, and process for submitting diversity action plans.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 […]
Six Benefits of Automating the Recruiting Flow in Clinical Trials
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 […]
How Artificial Intelligence is Transforming Clinical Trials: The Case of AstraZeneca
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 […]
CRISPR: The Promise of Gene Editing in Clinical Trials
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 […]
Hispanic Community In Clinical Trials. Tech Role.
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, […]
