Navigating the Complexities of Informed Consent Writing: Tips and Strategies for Clinical Researchers
Clinical research involving human subjects is crucial for the development of new treatments, drugs, and therapies, but it must be conducted in an ethical manner that protects the rights and well-being of the participants. Informed consent is the cornerstone of ethical research, requiring that participants or donors are provided with sufficient information about the study […]
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
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 […]
Top Professional Associations for Clinical and Regulatory Affairs
Professional associations are vital channels for knowledge sharing, networking, and staying on top of emerging trends in any industry. In clinical and regulatory affairs, these organizations play a pivotal role in shaping policies, providing educational resources, and fostering collaboration among professionals. Here’s a look at some of the leading associations in this field. 1. The […]
On Demand Webinar – Generating and managing structured, reusable data tables for data driven submissions
Overview Global health authorities will move away from unstructured submissions and toward a structured format for data and content. Using structured data from source to submission eliminates manual transcription, aggregation, and data table creation. This reduces resource needs, reduces errors, accelerates filing readiness, and supports initiatives like the ISPE Pharma 4.0 initiative to provide structured […]
On Demand Webinar – Automate Clinical Documents with Generative AI
Webinar Overview With the explosion of generative AI and the emergence of LLMs over the last year, what are the ramifications across the clinical document landscape? Increasingly, life sciences firms are leveraging content automation solutions to maximize the efficiency, accuracy, and standardization of reporting and writing processes. In this session, Tim Martin, Executive VP of […]
Enhancing Data Integrity in Clinical Research with Blockchain Technology
Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As these products must undergo extensive testing before being approved for the public, gathering high-quality, reliable and statistically sound data is an important goal for all […]