Protocol deviations for Visual Function Assessments (VFAs) in ophthalmology trials can affect the accuracy and reliability of outcomes. A VFA measures an individual’s functional or practical visual capabilities. This is in contrast to a standard eye exam, which includes a series of tests to measure real-world visual skills. VFAs perform both quantitative and qualitative assessments […]
Read More →In the drug development process, delaying the launch of a successful drug can result in lost sales. Early engagement to kickstart the clinical phase plays a key role in accelerating clinical trials and ultimately increasing revenue by providing earlier market access before competitors. Moreover, being the first to market a drug remains crucial for companies […]
Read More →The timely delivery of medical devices and ancillary equipments during early-phase clinical trials is integral as delays can push back study schedules and extend trial duration. Protocol adjustments may also be necessary as a result of these delays, which would hinder approvals and involve more paperwork. Sponsors frequently turn to new equipment or expedited shipping […]
Read More →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, […]
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