Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research
Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The European Parliament recently adopted […]
Data Management
Good Manufacturing Practices: When Do They Apply?
Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical teams maintain safety and quality from early trials to commercialization.
Developing a Data-driven Feasibility Process
Clinical research is complex and resource-intensive, and to understand just how far an organization’s resources can go, assessing a study’s
Key Items Auditors Look for When Reviewing an Investigator Site File
Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for preparing your investigator site file (ISF) for an audit.
Implementing eSource: A Guide for Operations and Technology Roles
Implementing eSource can streamline data collection for research sites, but ensuring data integrity, compliance, and accuracy is essential for successful adoption and reliable results.
Unpacking The Role of a Right-Sized QMS in Study Startup
The study startup process involves a multitude of tasks and activities multiple teams coordinate to ensure the successful study initiation.
A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.
Understanding Various Site Use Cases for eSource and EDC
Sites can improve data capture, management, and compliance using a site-centric eSource or EDC platform, supporting smoother workflows, remote monitoring, and efficient data analysis.
Key Efficiencies Driven by a Clinical Trial Management System
In today’s world of research, using a clinical trial management system (CTMS) can significantly streamline operations, and make for a
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African
NIH 2023 Data Management and Sharing Policy: What you Need to Know
In an effort to accelerate the sharing of biomedical research results, the National Institutes of Health (NIH) issued its finalized
How Paper and Electronic Source Data Meet ALCOA-C Principles
According to the FDA, data should meet certain fundamental elements of quality (ALCOA), whether they’re recorded on paper or electronically.