The landscape of clinical research is defined by an intricate web of regional, national, and global laws and regulations. Ensuring compliance with these frameworks is a cornerstone of effective clinical research. Regulatory compliance guarantees protecting participants’ rights and safety, minimizing disruptions from regulatory inspections. Furthermore, it ensures the accuracy and reliability of your clinical trial data.…
Clinical trials play a vital role in assessing the safety and effectiveness of new drugs. Historically reliant on paper-based methods, these trials often suffered from inefficiencies and errors. Fortunately, the emergence of electronic data capture (EDC) has revolutionized the process, enhancing efficiency and accuracy. This blog explores the significance of data quality in clinical trials and offers…
Over the past decade, the utilization of electronic data capture methods for comprehensive data collection and efficient management in clinical trials has gained significant traction. Electronic data capture is pivotal in aiding pharmaceutical companies and CROs in achieving peak efficiency in data management, database structuring, and trial analysis. These digital tools substantially curtail the time…
In the fast-paced world of clinical research, efficiency and data security are vital. It’s no secret that Electronic Data Capture (EDC) software has emerged as a game-changer in modern clinical trials, offering numerous benefits for organizations. In this blog, we’ll identify three hidden advantages of using EDC software for clinical trials that can revolutionize how…
The COVID-19 pandemic elevated the critical nature of global supply chains and underscored their vital importance in the healthcare market. As the world faced lockdowns, cargo flight reductions, material inventory shortages, and staffing issues, trial sponsors, clinical research organizations, and study teams had to collaborate to ensure trial continuity without compromising on time and cost.…
Interactive Response Technology (IRT) is a crucial component of modern clinical trials, serving as the core software system responsible for patient randomization and study supply chain management. Despite its long-standing usage and refined functionality since the mid-1990s, overlooking its significance or treating it as an afterthought could have serious consequences. An erroneous randomization or drug…
Clinical trials are expensive, and clinicians can’t afford to waste crucial resources when conducting efficient studies. Around 20-50% of studies don’t accrue subjects at the site level, leading to considerable waste in clinical research. Staff productivity levels and monetary resources are significantly affected. The implementation of technology, such as EDC systems, has automated significant processes, leading…
Forward-thinking clinical research organization (CRO) leaders are capitalizing on the advantages of cloud-based clinical trials to mitigate the substantial costs and lengthy timelines associated with traditional approaches. Embracing the flexibility, efficiency, and enhanced collaboration offered by cloud-based EDC systems can revolutionize the clinical trial landscape, streamlining processes and expediting advancements in medical research. Here’s how stakeholders…
During data collection and data entry in a medical research study, errors can occur. Research coordinators handling the shifting of the data might make a mistake in transforming them from paper-based formats to digitized ones. If these errors are left standing and not identified before analysis, they can distort the outcome of the clinical trial, which will…
When it comes to conducting clinical trials, one of the most important success factors is diversity and inclusion in the research process. This means that the participants of the research should represent diverse groups in terms of race, gender, ethnicity, socioeconomic status, and other demographical factors. Historically, it has been observed that minority and marginalized…