Over the last few years, the clinical trial landscape has rapidly evolved, with technological innovations playing a critical role in expediting key processes. The management of Electronic Trial Master Files (eTMF) in clinical research is one area that has seen tremendous change.  Incorporating Intelligent Automation and AI-driven applications has resulted in dramatic improvements in how eTMFs are developed, managed, and used throughout the clinical trial lifecycle. In this article, we will look at the importance of eTMF in clinical trials, the role of Intelligent Automation, and the revo ..read more

The management of clinical trial documentation is a crucial aspect of running efficient and compliant clinical trials. With rising costs and complexity of trials, having an electronic trial master file (eTMF) system has become pivotal. In this blog, we will understand what an eTMF is, its components, benefits, challenges, and why choosing the right eTMF system is critical for success. Purpose and Role of eTMF An eTMF refers to a software system that enables sponsors, CROs, and sites to store, access, manage, and archive all trial-related content electronically in a centralized, secure reposit ..read more

Saving people in clinical investigations is key. The Food and Drug Administration (FDA) follows strict laws, making sure vital steps are taken. This includes thorough tracking, recording, and holding essential info for the trial’s management. This post tackles the ins and outs of FDA rules. It talks about how important documents and data are in research.  We’ll also learn about the methods used by various groups— sponsors, contract research organizations, monitors, and research sites—to efficiently gather, share, and hold this valuable info. By navigating these regulatory waters and unde ..read more

Electronic trial master file in clinical research systems provide numerous benefits for TMF managers over traditional paper-based systems. Key advantages include improved collaboration through easy sharing of documents digitally across sites, CROs, and IRBs/IECs; significant time and cost savings from faster document searching, reduced printing/courier costs, and improved efficiency; enhanced quality control and inspection readiness thanks to centralized organization of all essential documents with tracking of document statuses; better visibility into key trial metrics for data-driven decisio ..read more

Clinical trials are an essential part of the drug and treatment development process. They allow researchers to systematically study the safety and efficacy of new interventions in humans before they become widely available. However, the current clinical trial system has limitations when it comes to patient choice and access.  Giving patients more options to participate could benefit individuals and society as a whole. This article will analyze the current landscape, make the case for expanding patient choice, discuss barriers, provide examples, weigh ethical considerations, suggest strat ..read more

Clinical trials are an essential part of developing new drugs and therapies. However, historically they have relied on paper-based data collection, which can be tedious, inefficient, and prone to errors. Electronic Data Capture (EDC) systems are revolutionizing clinical trials by enabling faster, more accurate data capture through digital means. As EDC systems continue advancing, they promise to reshape clinical trials and accelerate the drug development pipeline. What is an Electronic Data Capture (EDC) System? An Electronic Data Capture in clinical trials system is software that allows clin ..read more

Clinical trials play a crucial role in bringing new drugs and medical devices to market. Researchers rely on clinical trials to determine the safety and efficacy of new medical interventions in volunteer study participants. The data collected during clinical trials guides regulatory bodies on whether to approve these interventions for public use. Traditionally, clinical trials involved collecting data on paper case report forms (CRFs) which were then manually entered into a database for analysis. However, the past two decades have seen a major shift towards electronic data capture (EDC) syste ..read more

Nowadays, EDCs have become seamlessly compatible with various software in the eClinical field, making data transfer a breeze. It has become a typical practice to effortlessly import electronic data from external sources like imaging data sources, lab reports, and electronic health records into an EDC. Moreover, the rising trend of open-source EDC software and independent data standards (such as CDISC) is playing a significant role in boosting productivity. Keeping up with the ever-evolving landscape of data capture in clinical trials can be challenging amidst the increasing chatter surroundin ..read more

The implementation of robust data management infrastructure has become critical for modern clinical and translational research. This article discusses the development of a customized electronic data capture (EDC) and research data repository system catered for multi-site, multi-study clinical research. The system comprises dedicated modules for user account and access management, workflow-based study build with EDC clinical trials functionalities, centralized data storage, and advanced data retrieval and analytics functionalities.  Additional features including study data dashboards, rea ..read more

The incorporation of Electronic Data Capture (EDC) with several other cutting-edge technologies has emerged as a crucial catalyst for improving the effectiveness, accuracy, and general success of clinical trials in the quickly expanding field of clinical research. The clinical research process has been transformed by EDC, a sophisticated electronic system for data collecting and management. It offers several benefits, including data accuracy, efficiency, and real-time monitoring. However, in addition to examining the compelling advantages of combining EDC with other clinical research methods ..read more