AI in Electronic Data Capture (EDC) in clinical trials is reshaping how research teams collect, manage, and interpret study data. At its core, EDC is a software system designed to replace paper case report forms (CRFs) by enabling structured, digital data collection for clinical research. It allows investigators and site staff to enter, verify, and […]
Read More →Essential clinical trial tools and systems, such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master File), eConsent, and eCOA (electronic Clinical Outcome Assessment), form the digital backbone of modern research operations. These platforms simplify study planning, documentation, patient engagement, and data collection. They ensure trials are more efficient, compliant, and focused on patients. […]
Read More →For anyone seeking generic drug approval in the USA, a Bioavailability and Bioequivalence (BA/BE) study is often a critical step. These studies show the FDA that your product works just like the approved brand-name version, meeting strict guidelines for safety and effectiveness. Choosing the right global location for your trial, managing costs, and ensuring the […]
Read More →Clinical operations in North America are changing quickly. New technology and capabilities are appearing with more regulatory oversight, balancing these opposing forces, and clinical operations are experiencing further innovation and transformations. In this article, we examine the full spectrum of clinical operations, highlighting strategic innovations and robust oversight practices that have been adopted across North […]
Read More →Engaging Investigators early and proactively participating in a clinical trial in the preliminary planning and feasibility phases of a study. This method aids in ensuring site readiness, protocol viability, and alignment with actual clinical workflows. Sponsors and CROs can improve trial efficiency, compliance, and data quality by implementing investigator insights early on. This allows them […]
Read More →Early site engagement plays a critical role in the success of clinical trials, especially during the planning and protocol development stages. By involving sites early, sponsors and CROs can gain valuable insights into the standard of care (SOC) across different regions, assess the appropriateness of comparator arms, and better understand site interest and capacity to […]
Read More →Feasibility for rare disease clinical trials is not just a preliminary check. It is a strategic driver that shapes trial outcomes. With small patient populations, strict inclusion criteria, and limited site expertise, feasibility must be grounded in reality from the start. In rare disease research, every early decision carries weight. Misjudging patient availability, site readiness, […]
Read More →Early engagement strategies in clinical trials are one of the most underestimated yet critical factors in overcoming persistent challenges such as enrollment delays, low site motivation, and early site dropouts. Despite increasing complexity in trial designs, many sponsors still treat early engagement and feasibility as routine administrative tasks rather than strategic levers. In reality, early […]
Read More →Trackers in clinical trials are essential tools that help teams stay organized while enhancing oversight, improving accuracy, and ensuring smooth operational control. From patient enrollment to regulatory timelines, trackers make it easier to manage complex tasks, keep everything on schedule, and support better decision-making throughout the trial. Trackers in clinical trials play a vital role […]
Read More →The success of any clinical trial hinges on meticulous planning, starting with the careful identification of red flags in site selection to effectively avoid pitfalls before the trial starts. A poorly selected site can lead to costly delays, data inaccuracies, and regulatory complications, ultimately jeopardizing the trial’s objectives. Addressing these challenges early in the process […]
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