We are thrilled to share several key enhancements that will streamline your workflows and improve data management. Enhanced Duplicates Search Our Duplicates Search feature has received a significant upgrade! The system now identifies 100% duplicate files from your Inbox by checksum, ensuring cleaner data management. When files are moved from the Inbox to any folder […]
Two popular models dominate the Clinical Trial management System landscape: Cloud-based and On-premises CTMS. Both have their merits, but choosing the right option depends on several factors, including cost, scalability, security, and operational requirements. This article will explore the differences between Cloud-based Clinical Trial Management System and on-premises CTMS, helping you determine which solution best […]
Implementation of a Clinical Trial Management System (CTMS) can streamline operations, improve data management, and enhance trial oversight. However, the process also brings a range of challenges that must be addressed to achieve a successful implementation. These challenges often stem from technical and human factors, including data quality, system integration, and regulatory demands. Identifying these […]
We are excited to share that Flex Databases has been named a Top Clinical Management Provider for 2024 by Life Science Review. This prestigious recognition highlights our strong reputation and the trust placed in us by both customers and industry peers, reflected in numerous nominations from Life Science Review subscribers. This award comes at a […]
Clinical trials provide essential information on the safety and effectiveness of drugs. Sponsors ensure that investigators follow protocols and collect and report quality data. Quality in clinical trials means that the product or service meets applicable regulations and customer requirements. A Quality Management System (QMS) in clinical research ensures compliance with ethical, regulatory, and GxP […]
Metronomia, a leading Data Management and Biostatistics CRO in EU, has selected Flex Databases’ eTMF module to support one of its biotech clients. Simon Rückinger, Managing Director at Metronomia Clinical Research GmbH, explained their decision and what they expect from the partnership. “We needed a flexible and simple eTMF solution that could meet the specific […]
Clinical Data Management Systems (CDMS) and Clinical Trial Management Systems (CTMS) are two key tools that play crucial roles in this process. While they might sound similar, they serve distinct purposes and offer different functionalities. What is a Clinical Data Management System (CDMS)? A Clinical Data Management System (CDMS) is a specialised tool designed to […]
A regulatory binder is crucial for managing clinical trial documents, it ensures compliance with regulations, and makes audits easier. It helps keep important documents organized and readily accessible for trial monitors, auditors, and regulatory authorities, and serves as a useful reference for the research team. While it’s not legally required, maintaining a regulatory binder is […]
Trial master files (TMFs) are essential for completing clinical studies, but managing TMF content can be very complex. Electronic trial master file (eTMF) systems represent the next step in clinical trial document management and are becoming an integral part of future clinical research. What is an eTMF? An electronic trial master file (eTMF) is a […]
Clinical trials play a crucial role in medical progress, yet effective management is essential to maximize their impact. Administrators must craft a thorough strategy to enhance how trials are managed. Here are five strategies to transform clinical trial management, providing administrators with the tools and insights needed to navigate healthcare research challenges effectively. Simplify planning […]
Effective site selection and management are critical components of successful clinical trials. Choosing the right locations and overseeing their operations can significantly impact the trial’s timeline, budget, and ultimately, its success in delivering reliable data. This article explores essential strategies for optimizing site selection and management, highlighting key considerations, practical tips, and the role of […]
Handling a Trial Master File (TMF) can be tough for clinical teams, but it doesn’t have to be. Old systems with outdated file sharing methods or homemade systems with spreadsheets or paper can make managing sensitive trial data risky. Over the past decade, electronic Trial Master File (eTMF) systems have helped many biopharma companies and […]
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