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 →
The FSP model in Thailand is rapidly transforming how global clinical trials are conducted by combining local expertise with international best practices. In this model, dedicated teams in Thailand handle specific trial functions, helping sponsors achieve faster approvals, smoother site management, and better patient recruitment. We will discuss this model in detail throughout the article, […]
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 →
Site engagement plays a key role in the success of clinical trials. Starting engagement at the right time and managing it well can make the trial process easier and more efficient. Using engagement strategies from the planning stage to post-trial collaboration helps overcome challenges like patient recruitment, ensures compliance, and improves data quality. This approach […]
Read More →
Successful clinical trials are undoubtedly the result of a well-implemented Quality Management System (QMS), and integrating Quality by Design in clinical trials ensures that this system goes beyond merely fulfilling regulatory requirements. Incorporating a proactive approach like Quality by Design (QbD) while configuring a QMS structure for clinical trials raises the probability of risk management […]
Read More →