Currently, there are a lot of different types of EDC systems on the market. This means you’ll have to consider various factors before making your decision. Here, we discuss the most common features of a modern clinical EDC system and data management platform. Modern Clinical EDC Systems Automate Data Cleaning The coronavirus pandemic has driven…
An EDC (electronic data capture) system – also known as eCRF (electronic case report form) – is an extremely important software tool in clinical trials. Clinical research relies on accurate data. To gather, clean, and analyze the data generated in clinical studies, EDC solutions are used. Here, we talk about the users of electronic data…
Challenges for Decentralized Clinical Trials: Will they be effective? Many life sciences organizations had to quickly adopt remote data collection processes and technologies while conducting clinical trials during the Coronavirus pandemic. This was done to keep clinical trials running and to ensure patients’ safety. Consequently, a lot of organizations adopted decentralized clinical trial models in…
Today, the importance of harnessing clinical trial data has never been more relevant. Heathcare practitioners strive to deliver therapies that improve the lives of patients. However, the clinical data we produce can significantly impact our success in accomplishing this goal. A high-quality clinical data package is an important requirement for a new therapy to acquire…
Delays and interrupted studies in new trials pose a lot of challenges for sites, patients, and all key stakeholders throughout the clinical trial journey. Given the recent Covid-19 pandemic, the value of virtual clinical trials in something that requires a closer look. When CROs invest in proven innovative technology that offers an array of virtualization…
Risk management consists of a number of processes or activities that are undertaken throughout the lifecycle of a clinical trial for identifying, evaluating, monitoring, controlling, preventing, mitigating, communicating, and reviewing any process (or factor) that threatens the trial’s quality. Here, we discuss how to manage risk in clinical trial development. Risk in Clinical Trial Development –…
Emerging biopharma sponsors drive innovation in clinical trials, and their choice of technology plays an important role in fueling this innovation. Today, sponsors can choose clinical trial technology give the explosion of growth in healthcare technologies. For many emerging biopharma companies, this occurs after CRO selection. However, treating technology as an afterthought isn’t recommended as…
Decentralized clinical trial technologies (DCTs) may include at least one of the following patient engagement components: wearable sensors to collect data from a patient, telemedicine, ePRO (electronic patient-reported outcomes), eConsent, and delivery of study devices, medication, as well as other supplies directly to patients through an RTSM (randomization and trial supply management system). It doesn’t…
Recently, the decentralized clinical trials have become an important topic of development and discussion, which is enabled further by the progression of available technologies. Here are some advantages of decentralizing clinical trials. Decentralized Clinical Trials – Less Disruption of Daily Life While participation offers patients new hope and access to a promising new therapy, it…
With time, clinical trials are becoming more intricate and convergence of forces—including precise value differentiation, increasing protocol complexity, and more emphasis on patient experience—is accelerating this intricacy. Clinical electronic data capture systems and processes have evolved to include adaptive designs, DCTs (decentralized clinical trials), increased data volume and precision, and an ever-expanding array of data…