Industry Discussions What is a Phase 1 Clinical Trial? AQ The Phase 1 clinical trial is the first stage in the clinical testing of a new drug or treatment in humans. This is primarily concerned with assessing the safety, tolerability, pharmacokinetics (how the body absorbs, distributes, metabolizes, and excretes a drug), and pharmacodynamics (the effects […]
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Industry Discussions What Does CAPA Stand For In Clinical Trial Research? AQ Clinical trials are the backbone of medical advancements, but they require rigorous quality management to ensure participant safety, data integrity, and compliance with regulatory standards. For this, the CAPA solution must be integrated and leveraged effectively. Today, we’ll grasp what does CAPA stand
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Industry Discussions 5 Proven Patient Recruitment Strategies in Clinical Trials AQ Clinical trial success hinges on effective patient recruitment strategies, which require a patient-centric approach and a blend of outreach methods. Indeed, delays in recruitment can incur significant costs for sponsors, possibly depriving patients of timely access to innovative trial treatments. You can adopt some
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Industry Discussions Transforming CAPA Management in Clinical Trials Research For Enhanced Quality and Efficiency AQ Ensuring the integrity and reliability of data is highly crucial yet challenging in clinical trials. Anyhow, with Corrective and Preventive Action (CAPA) management, it becomes seamless to maintain quality and compliance in real-time. Let’s examine the limitations of traditional CAPA
Industry Discussions E-Delegation in Clinical Trials: Overcoming Traditional Challenges AQ Increasingly, the shift from traditional methods to digital innovation is marking a significant turning point in clinical trials. ‘E-delegation’ is one such innovation, which encapsulates the transition from paper-based delegation logs to electronic systems. This shift is more than a mere technological update. It revolutionises
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Industry Discussions Who Uses CTMS Solutions and Why? AQ The implementation of cutting-edge tools is transforming the way professionals manage and conduct clinical trials, right? CTMS is at the forefront of this technological revolution. From pharmaceutical companies to academic institutions and research organisations, everyone uses CTMS solutions, as these are designed to: Help with centralised
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Industry Discussions What is CAPA Management Software in Clinical Research? AQ CAPA Management Software in clinical research is designed to implement Corrective and Preventive Actions, addressing compliance issues to prevent recurrences. This software ensures participant safety, protects their rights, and maintains data integrity. It streamlines clinical trial processes, enhancing project quality through proactive issue resolution
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Industry Discussions How Long Do Clinical Trials Take? AQ Objective Response Rate (ORR) in clinical trials is the proportion of patients demonstrating either a partial response (PR) or a complete response (CR) to a specific treatment. It excludes stable disease and provides a direct quantitative measure of the treatment’s ability to induce a meaningful reduction
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Industry Discussions How Long Do Clinical Trials Take? AQ According to Cancer Research UK, the timeline for drug testing and approval varies widely. There’s no fixed duration, but completing all phases of clinical trials even with the help of a CTMS, may take 10 to 15 years or more. This timeline includes licence issuance as
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Industry Discussions What is the Difference Between CTMS and eTMF? AQ In clinical trial research management, the Clinical Trial Management System (CTMS) and the Electronic Trial Master File (eTMF) play distinct yet important roles. CTMS focuses on operational efficiency—overseeing site management and subject recruitment. In contrast, eTMF is an electronic repository—emphasizing document integrity, version control,
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