AI Enabled Content Generation for Clinical and Regulatory Documents

Regulatory affairs

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?

a person holding a laptop

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 […]

AI in Drug Repurposing: Finding New Uses for Existing Medications

ai drug discovery

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 research

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

clinical research documents

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

clinical trial

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, […]

Three Ways AI (Artificial Intelligence) is Being Used to Streamline Clinical Trials

Artificial Intelligence (AI) has been continuously integrated into the field of clinical research. A formerly time-consuming workflow has now been shifted into an efficient process with lowered cost, less labor and improved clinical trial outcomes. As society shifts into a technology and digital driven era, it is important to see how this can be leveraged […]

Key Regulatory issues to monitor for clinical trials in 2024 and beyond

government regulations

The regulatory landscape surrounding clinical trial data is undergoing continual expansion and complexity, necessitating vigilant attention from clinical researchers as they navigate evolving regulations. Influential policy recommendations and guidance documents are starting to surface against this dynamic backdrop in important countries like the US, the EU, Canada, and beyond. These projects have the potential to […]