Category: TrialPal

Clinical trials have always required informed consent, guaranteeing that participants are fully aware of the study’s goals, methods, and risks. However, conventional, lengthy consent forms often frustrate potential volunteers and delay enrollment, especially in vaccine clinical trials. A new study, funded by the NIH’s CTSA Program, points in a different direction.   This study implemented… Continue reading Clinical Trial Enrollment is Faster with eConsent

“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 “Utilizing ePROs not only facilitates better data collection but also contributes to improved quality of care and patient safety”. “FIdec achieved over 98% patient adherence using the proper ePRO” ePRO stands for electronic Patient Reported Outcomes. This system allows patients to report their health status, symptoms, and quality of life using digital… Continue reading Electronic Patient-Reported Outcomes in Clinical Trials

Table of Contents When developing new vaccines, patient safety is paramount. Phase I vaccine trials determine safety and efficacy before public release. Data collection is crucial for evaluating the vaccine’s performance.   Electronic Patient Reported Outcomes (ePRO) are valuable tools in ensuring patient safety during Phase I vaccine trials. This article explores the importance of… Continue reading Phase I Vaccine Trials & ePRO: Ensuring Patient Safety  

Artificial intelligence (AI) and machine learning (ML) herald a new era of regulatory operations in clinical trials. These advanced technologies are revolutionizing how companies manage regulatory data, predict outcomes, and ensure compliance, ultimately leading to greater efficiency and accuracy.   From the IQVIA article published on its website on June 10, 2024, we would like… Continue reading 4 Key Benefits of AI & Machine Learning in Clinical Trials

From the ideation of the scientific question, sponsors can consider integrating ePRO tools in protocol designs. Decentralized and hybrid clinical trials can widen the data points and make the most of each trial. Here we share five steps to introduce an ePRO into a protocol: Define the objectives an ePRO tool can address: Identify the… Continue reading How to include an ePRO in your protocol design

What is electronic patient-reported outcomes (ePRO)? ePRO stands for “Electronic Patient-Reported Outcomes.” It is a tool that allows patients to record electronically and submit their health outcomes digitally using devices such as smartphones, tablets, or computers. Electronic patient-reported outcomes (ePRO) is an innovative tool that transforms how data is collected and analyzed in clinical trials. … Continue reading What is ePRO, Electronic Patient-Reported Outcome?

Table of Contents The global eCOA market is poised for significant growth in the coming years. Grand View Research shows the market is expected to reach $20.5 billion by 2028. eCOA (electronic Clinical Outcome Assessment) uses electronic tools and technologies to collect and evaluate patient outcome data in clinical trials and clinical research. It allows… Continue reading Electronic Clinical Outcome Assessment (eCOA): What is and Who Uses it?