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 […]
Astrix Clinical Services Case Study: Clinical Development Technical Strategy
Optimizing Clinical Development Using a Data-Driven Technical Strategy Clinical development is essential for providing safe and effective medications to patients in a timely and cost-efficient manner. Research and development of new medications can be a lengthy process, and clinical trials are often complex, expensive, and time-consuming. To combat these issues, pharmaceutical companies must create a […]
Case Study: Structured Content Management Strategy in a regulated clinical trial environment
Structured Content Management Strategy for a Global Pharmaceutical Company Challenges in regulatory document authoring and management are common for many global pharmaceutical companies, where document flow and content reuse must be optimized to ensure compliance and improve user experience. For one such company, an assessment of their current state revealed the need for increased alignment […]
Case Study: Regulatory Information Management
RIM Migration and Management for a Global Pharmaceutical Company A major pharmaceutical company was faced with the challenge of streamlining its regulatory submissions process globally. They required a solution that would harmonize their planning, tracking, authoring, publishing, submission, archive, and correspondence with Health Authorities, and selected Veeva RIM as the technology platform to support this […]
White Paper – FDA Draft Guidance Summary Decentralized Clinical Trials for Drugs, Biological Products, and Devices
White Paper from Astrix Clinical Services The US Food and Drug Administration (FDA) has released a draft guidance document on decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. This guidance outlines the FDA’s recommendations for designing, executing, and evaluating these trials and provides guidance on ensuring patient safety and the accuracy of […]
Developing Clinical Trial Orchestration Capabilities Strategy
Overview Decentralized Clinical Trials (DCT) have disrupted our models for clinical trial execution. The ultimate goal is to bring the trial to the patient by seamlessly orchestrating trial activities in an intuitive and seamless user experience for patients, sites, and sponsors. In this case study, we will explore how a global pharma company leveraged Astrix’s expertise […]
Astrix On Demand Webinar – Navigating the Impact of New EU Regulations EU CTR
Overview: The EU Clinical Trial Regulation (EU-CTR) and Clinical Trials Information System (CTIS) have revolutionized the regulatory landscape and significantly impacted how sponsors manage electronic trial master files (eTMF) and regulatory information management (RIM) systems. With these changes come difficulties and complexities that require organizations to be prepared to navigate them effectively. In this informative […]
Accelerate the Implementation of eTMF Systems with Risk-Based Validation Montrium Trial Master File (TMF) Week 2023
“Accelerate the Implementation of eTMF Systems with Risk-based Validation,” presented by James O’Keefe, industry expert and Head of Clinical and Regulatory Consulting Services at Astrix. This session will provide attendees with practical insights on how the transition to SaaS systems enables you to streamline the implementation and validation of eTMF (electronic trial master file) systems […]
Astrix Partner Blog – Highlights and Information from Veeva’s TMF Innovation Forum 2023
The much-awaited Veeva TMF Innovation Forum was held this year in Philadelphia—the forum aimed to promote lasting changes in clinical trial management related to the electronic Trial Master File. The event was a remarkable opportunity for industry leaders to come together, share current thinking on critical matters, and further the development of clinical trials, with […]
FDA Draft Guidance Summary — Decentralized Clinical Trials for Drugs, Biological Products, and Devices
The US Food and Drug Administration (FDA) has released a draft guidance document on decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. This guidance outlines the FDA’s recommendations for designing, executing, and evaluating these trials and provides guidance on ensuring patient safety and the accuracy of the data generated. Additionally, it includes […]