Monitoring visits are indispensable in clinical research to guarantee data integrity, mitigate protocol deviations, and ensure regulatory compliance. Clinical Research Associates (CRAs) carry out these visits, which frequently occur at various locations and studies. If they don’t receive the proper help, these professionals deal with concerns like inconsistent documentation, delayed communication, and trouble keeping… Continue reading Monitoring Visits in Clinical Trials
“In vaccine clinical trials, missing safety data in daily collection creates challenges in reporting safety outcomes to the agencies”. This was one of the key takeaways from our latest webinar on safety tracking in vaccine trials. What is the result of poor tracking in vaccine clinical trials? Missed cases or adverse events |… Continue reading Efficacy in Vaccine Clinical Trials. [Best Practices for Safety Tracking]
In vaccine clinical trials, tracking participant safety is non-negotiable. Unlike drug trials, vaccine clinical trials involve healthy volunteers, making real-time monitoring of adverse events (AEs) crucial. However, many trials face challenges with delayed reporting, missed safety data, and compliance risks, potentially compromising trial outcomes. Why Is Safety Tracking So Challenging in Vaccine Clinical Trials? In… Continue reading Vaccine Clinical Trial Outcomes: The Impact of Monitoring Safety and Efficacy Tracking
Patient adherence and data accuracy are non-negotiable in vaccine clinical studies. Inadequate reporting can jeopardize regulatory submissions, raise expenses, and postpone the conclusion of studies. However, many vaccine clinical trials are plagued by low adherence rates and ineffective data collection, which can result in insufficient safety monitoring and possible protocol violations. TrialPal, a… Continue reading Protocol Adherence in Vaccine Clinical Trials with TrialPal
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… Continue reading A New Era for Clinical Trials: The ICH E6(R3) Guideline 2025
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:… Continue reading Are You Prioritizing Participant Safety in Your Vaccine Trials?
Table of Contents Introduction Regulatory compliance in clinical trials is a cornerstone for ensuring participant safety, data quality, and scientific validity. For many organizations, achieving compliance is a significant challenge that demands advanced technological tools. For PROBEBÉ, implementing Trial360 transformed their regulatory management process, enhancing efficiency and adherence to international regulations. See how they… Continue reading Regulatory Compliance in Clinical Trials: A Complete Guide
Table of Contents In clinical research, centers face numerous challenges in managing processes, data, and regulations. An ERP-CRM solution like Trial 360, based on the robust Odoo platform, provides essential tools to address these issues and improve operational efficiency, traceability, and regulatory compliance. Main Challenges and Solutions with Trial 360 Disorganized Clinical Trial Management Pain:… Continue reading Clinical Research Center Challenges: How an ERP CRM Solution like Trial 360 Based on Odoo Solves Them
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… Continue reading Integra IT to Exhibit at the European Site Solutions Summit 2025 in Lisbon
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… Continue reading Emmes Group Transforms Vaccine Research: Wins Fierce CRO Award 2024
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