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 […]
On Demand AI Webinar – In the world of AI Think Patient Not Technology
A webinar sponsored by Astrix Presented by: Sriharsha Chigurupati – Head of Engineering, Slickbit & Gayatri Tadinada – Lifesciences Consultant, Slickbit Overview The largest stakeholder in the Life Sciences ecosystem is the patient. It is our continuous endeavour to design services keeping them at the centre. With the latest advancements in technology we are at […]
On Demand Webinar – Data driven content – FHIR and the future of Regulatory Submissions
Overview The shift to structured content and data has been a long-term objective for regulatory agencies and the Biopharma industry. However, progress has been hampered by a lack of open and broadly adopted industry standards and tools. While the Electronic Common Technical Document (eCTD) is a widely adopted standard for regulatory submissions, it only uses […]
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, […]
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 […]
Essential Guide to – FHIR (Fast Healthcare Interoperability Framework from HL7 )
Within modern healthcare technology, data interoperability has become a prominent topic across the field. As technology has continually improved, so has the ability to record healthcare data digitally. Electronic health records (EHRs) must be accessible across platforms for specified parties, while protecting data integrity. Seamless data exchange improvements are sought after in the field by […]
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 5 Technology Trends to Keep an Eye on in Clinical Research in 2024
There is no denying that technology is continually advancing year by year, month by month, and even day by day. As expected, this affects the scope of clinical research in 2024. While we learn to adapt and implement these technologies in our everyday lives, the clinical research field is working to capitalize upon these advancements […]
Clinical Trials 101: Your Guide to Understanding How It Works
In the world of medical research, clinical trials are the forefront of advancement of research. They bridge the gap between laboratory breakthroughs and real-world treatments, ensuring that new drugs, therapies, or devices are both safe and effective. This comprehensive guide aims to shed light on these vital components of healthcare advancement. What are Clinical Trials? […]
On Demand Webinar – Decentralized Clinical Trials and Digital Health Navigating the Opportunities and Challenges
Overview: As the healthcare industry pushes towards modernizing clinical trials, recent draft guidance from the FDA, ICH, and others aims to guide the industry in adopting decentralized clinical trials (DCT) and digital health technologies for remote data acquisition. These new approaches present a significant opportunity to transform the way clinical trials are conducted, with potential […]