If you’re evaluating a modern clinical data management system, here’s what to look for in 2026, especially with a focus on regulatory compliance, EDC/RIM integration,
Clinical trials are more complex than ever in 2026, generating massive volumes of structured and unstructured data. Sponsors and CROs must ensure that this data
The era of stitching together disconnected e-clinical tools is ending, and the transformation is accelerating faster than expected. Clinical trials face unprecedented complexity. Decentralized models
The global clinical research landscape is undergoing a transformative shift with the adoption of ICH E6(R3)—the much-anticipated revision of the International Council for Harmonization’s (ICH)
Clinical trial technology is supposed to streamline operations, not slow them down. But too often, the stack becomes the source of delay. This checklist outlines
The pharmaceutical industry stands at a pivotal moment in regulatory science. As artificial intelligence transforms drug discovery and development, regulatory agencies worldwide are grappling with
Clinical trials are changing fast. New technologies, stricter data requirements, and pressure to speed up drug development are reshaping how we run studies. Here’s what
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the
