In any clinical trial conduct, recording and storing data in a controlled, consistent, and reproducible manner for data retrieval and analysis is a necessity for regulatory compliance and clinical study success ..read more

Advancements in preclinical and clinical research are driving major changes across various therapeutic areas, steering the industry into a new phase of medical innovation. Each scientific field whether it be oncology, dermatology, rare disease, or others, presents unique challenges and opportunities that are crucial to improving patient outcomes, as well as guiding the efforts of researchers, physicians, and pharmaceutical companies in advancing healthcare solutions globally. In this article, we cover the intricacies of therapeutic areas within clinical research, explore recent developments ..read more

SAS® (Statistical Analysis System) is a powerful tool widely used in clinical programming, data analysis, and reporting. Whether you’re working on clinical trials or handling complex data analyses, mastering SAS® programming techniques and managing large datasets efficiently are crucial for successful outcomes. In this article, we’ll explore our top 5 SAS® tips and tricks, key SAS® techniques that enhance coding efficiency, and delve into best practices for handling large datasets. By integrating these strategies, you’ll be well-equipped to optimise your SAS® programming and tackle the challe ..read more

As oncology treatments advance, optimising dose selection has become a key focus for improving patient outcomes. The FDA’s Project Optimus aims to address this need by reshaping traditional dose-finding methods, prioritising both efficacy and long-term tolerability. In this article, we discuss the objectives and implications of Project Optimus, exploring its potential to transform oncology clinical trials and enhance cancer treatment strategies ..read more

  The Importance of SAS Quality Control in Clinical Trials Quality control (QC) in clinical trials is essential for ensuring the integrity and reliability of data. Leveraging SAS (Statistical Analysis System) for QC processes offers a powerful solution for clinical researchers. SAS provides comprehensive tools for data analysis, reporting, and validation, making it an ideal choice for QC tasks. By integrating SAS with robust QC methodologies, clinical trials can achieve higher standards of accuracy and compliance ..read more

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The integration of Artificial Intelligence (AI) and Machine Learning (ML) in clinical trial design is beginning to reshape the pharmaceutical and medical research industries. Our article explores the methods by which AI and ML are modifying clinical trial design, with a focus on recent advancements and methodologies endorsed by regulatory bodies and used by industry leaders ..read more

Clinical research serves as the foundation for advancing medical knowledge, improving patient care, and ensuring the safety and efficacy of new investigational products. As a result, clinical trials must be performed to the highest degree of scientific and ethical standards, for results to be recognised as credible and the trial deemed as successful. One document which plays an essential role in the safety, traceability and overall validity of a clinical trial is the Statistical Analysis Plan (SAP ..read more

For outputs from individual studies to be considered sufficient, they must fully address regulatory questions on their own, without requiring readers to combine information from multiple tables. Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses are crucial components in regulatory submissions for clinical trials. ISS/ISE analyses using SAS involves several steps. Here's a general overview of how you can conduct these analyses ..read more

In recent years the requirement for maintaining a robust audit trail has become crucial for ensuring data integrity, transparency, and compliance with regulatory requirements. An audit trail is a comprehensive log that records all activities, including modifications, additions, and deletions of data, within a clinical trial. It acts as a chronological record that helps trace the path of data, providing evidence that the data collected was performed in accordance with the protocol and regulatory standards. Understanding and navigating the regulations surrounding audit trail review is essential ..read more