The silent (and growing) expense of paper-based clinical trial sites For years, paper-based documentation has been the standard in clinical trial operations: A-Z folders, pens, highlighters, envelopes, printed paper, and storage boxes are considered just another part of the job. Because it’s such a constant and familiar expense, many assume “paper doesn’t cost anything”—just because… Continue reading “Paper doesn’t cost anything”… Are you sure?
How TrialPal MOVI Reduces Errors and Ensures 21 CFR Part 11 Compliance in Clinical Trial Monitoring In modern clinical trials, monitoring visits are critical for ensuring data integrity and participant safety. Yet many contract research associates (CRAs) still rely on paper-based processes or non-validated tools, increasing the risk of errors, delays, and compliance violations. TrialPal… Continue reading Are Your CRAs Still Using Paper or Non-Validated Tools?
When Technology Becomes a Barrier, Smart Device Management is the solution Electronic data capture through eDiaries is a proven tool for improving patient-reported outcomes and real-time symptom tracking in clinical trials. However, in many decentralized or hybrid studies, particularly those involving underserved or rural populations, a critical issue arises: not all participants have access to… Continue reading Bridging the Gap: Smart Device Management for Seamless eDiary Use in Clinical Trials
In clinical research, ensuring that a participant meets eligibility criteria and is not enrolled in multiple studies simultaneously (co-enrollment) is critical to ensuring scientific validity, patient safety, and regulatory compliance. However, in many centers with manual workflows, Excel spreadsheets, or disconnected CTMS, errors are common that could affect data integrity or even lead to… Continue reading Co-enrollment, Eligibility, and Compliance: How to Prevent Errors with Real-Time Technology
Introduction Early-phase clinical research centers face unique challenges: complex protocol designs, tight timelines, high data quality expectations, and increased regulatory scrutiny. Sites still relying on paper or disconnected systems often struggle with inefficiencies that impact recruitment, protocol compliance, and billing accuracy. Unlike other platforms, Trial360 integrates all critical modules (CTMS, eSource, CRM, finance) into… Continue reading How Early-Phase Sites Are Streamlining Operations with eSource & Protocol Workflows
On April 22nd, we celebrated Earth Day, which calls for action, environmental awareness, and the transformation of our habits. But beyond the symbolic messages, this date also leaves us with a key question: What are we doing in our industry to reduce our environmental impact? Clinical research faces a silent but profound challenge: dependence on… Continue reading After Earth Day: What are we doing for a more sustainable future in clinical research?
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
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
