eCOA and Digital Health Technology: Why Direct Data Capture Demands Disciplined Project Management
eCOA and Digital Health Technology In the mid-2010s, a Phase III trial’s data footprint was measured in the hundreds of thousands of data points; case report forms (CRFs), lab values, and site-based assessments collected a handful of times per patient over the course of a study. Tufts estimated that as of 2012, the average Phase […]
The Strategic Guide to Clinical Research Technology in 2026
In this blog, we explore the full stack of clinical research technology in 2026. Clinical trial delays carry substantial financial consequences: a Tufts CSDD analysis associated a single day of delay with approximately $800,000 in unrealized prescription drug or biologic sales (Smith, DiMasi, & Getz, 2024) [1]. It’s essential to navigate the complexities of various […]
The Rise of the Data Quality Oversight Architect in Clinical Trials
How next-generation clinical trials will operate from one curated view of trial health. Data quality oversight in clinical trials has gained momentum in recent years. For most of the past two decades, clinical trial oversight has been an exercise in reconciliation. The Clinical Trial Manager works from one set of operational reports. Data Management works […]
Astrix Blog – 2025 Content Review – A selection of our top blogs and webinars
As we bring 2025 to a close Astrix always likes to select and share some of our most popular content from the the year in review. We have selected a group of blogs and on-demand webinars that received the most likes, shares and clicks in 2025. This year we focused our topic areas on several […]
AI Enabled Content Generation for Clinical and Regulatory Documents
What is the current state of AI in clinical and regulatory content? In Part One of our three-part series, we assessed your organization’s AI readiness for automating regulatory and clinical trial document creation. In Part Two, we explored Structured Content Authoring, defining this essential building block to establish modular frameworks representing all the data associated with clinical […]
How are AI/ML technologies currently used for R&D applications?
AI/ML technologies are rapidly reshaping the R&D landscape, particularly in drug discovery, where groundbreaking tools transform how researchers identify and develop new treatments. These technologies provide the ability to analyze complex data, automate processes, and uncover insights that were once out of reach. With their power to drive efficiency and innovation, AI/ML is making a […]
AI for Clinical and Regulatory Documents: From Hype to Value
The allure of Artificial Intelligence (AI) is hard to ignore. From automating repetitive tasks to deriving insights that drive strategy, organizations everywhere are sprinting to embrace AI solutions. According to Gartner, by 2026 60% of organizations will abandon AI projects unsupported by AI-ready data. But as more companies race to deploy AI, many overlook fundamental […]
Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
Many companies are leveraging AI to streamline their clinical trial operations. However, achieving a holistic view of the entire study lifecycle remains a challenge. The key metrics and data points required to keep projects on track are often manually tracked across people, processes, and systems, leading to delays and inefficient corrective actions. To improve clinical […]
AI in Drug Repurposing: Finding New Uses for Existing Medications
The field of medicine has seen an explosion of technological advancements in recent years, and artificial intelligence (AI) is at the forefront of this revolution. One of the most promising areas where AI is making a significant impact is in drug repurposing. This practice involves identifying new therapeutic applications for existing drugs, which can dramatically […]
Clinical Trials: Trends to Watch For In Next 5 Years
Clinical trials are at the heart of medical innovation, driving the development of new treatments and therapies. As we look ahead to the next five years, several key trends are set to revolutionize the landscape of clinical trials. From technological advancements to regulatory changes, here’s a closer look at the biggest trends shaping the future […]
The Benefits of Implementing Digitized SoA in Clinical Research Protocols
The Schedule of Assessments (SoA) in clinical research protocols serves as one of the most important roadmaps clinicians, researchers, sponsors, and monitors use to guide the trial from start to finish. This roadmap, also sometimes referred to as the Schedule of Activities or the Schedule of Events, outlines study visits and scheduled activities expected for […]
Enable Your Drug Development CMC Digital Transformation Strategy with a SCDM Guided Workflow System
Overview The Chemistry, Manufacturing, and Controls (CMC) Module 3 component of the Common Technical Document (CTD) required for pharmaceutical regulatory submissions requires extensive documentation, including drug substance and drug product information, manufacturing processes, analytical methods, stability studies, and more. Managing the manual transcription and compilation of this documentation consisting of text annotations, images, data, tables, […]