Before beginning your study, you must select a suitable clinical trial management system (CTMS) Vendor that can not only benefits your research organization but is also patient-centric. When you’re in the market for an appropriate CTMS, you should look for one that fits well with your research goals and meets all your requirements. To that…
A screen failure in clinical trials happen when potential participants undergo a screening process designed to determine whether they fit the study’s inclusion criteria, and despite fitting the criteria, they fail to enroll in the trial. While there’s no standardized screen failure information for different studies, some studies show a higher incidence of screen failure.…
It was 2011 when Pfizer, for the first time in the history of clinical trials, initiated a virtual clinical study to test one of its drugs. While the project did not get to reach the completion stage owing to a lack of electronic data capture tools and redundancies in the system, it surely gave a…
The research industry is changing rapidly and embracing patient-centric practices. When COVID-19 restrictions came into effect, a large part of the industry moved to remote modalities for the sake of research continuity. With these remote practices, researchers became more conscious of the participant experience and prioritized the participants’ comfort. That said, simply moving to remote research…
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…
Clinical trial training is essential to explain the specifics of a complex research protocol. To that end, the training programs are designed while keeping in mind good clinical practices (GCP), International Conference on Harmonization (ICH), and other regulatory matters. But how can you make your clinical trial training more effective and streamlined? Here are some tips…
According to the estimates, over $2 billion were recovered under the False Claims Act cases in 2020. Every year, a significant number of clinical trial sponsors are legally penalized and face delays in their research study results owing to errors in budget and billing compliance. Some even jeopardize their studies by constantly getting flagged by the…
In recent years, more and more clinical trial sponsors and organizers have moved to decentralized clinical trials to avail the various benefits of the model. From a faster recruitment process to a highly diverse participant pool, decentralized clinical trials (DCTs) have offered many benefits to modern-day clinical research. But in the midst of all the…
According to governmental data, there are over 400,000 clinical trials taking place in the US currently. A vast majority of these trials are now moving to electronic data capture (EDC) software that allows practitioners and researchers to improve their data management, accelerate the process, and leverage modern clinical research approaches. However, despite the vast popularity of…
Setting up studies and ensuring their seamless operation is a difficult task. It is a multi-faceted process that can be prone to unnecessary delays. There are a lot of stakeholders and decisions involved in setting up study sites. The process can be overwhelming for sponsors, CROs, research sites, and clinicians and has historically been marred…