Industry Discussions What are the Best Practices for Selecting a Clinical Trial Site? AQ What is a Clinical Trial Site? Clinical trial site is a designated location where clinical trials are conducted to test the efficacy and safety of pharmaceutical compounds or medical devices on humans. It can be an academic medical centre, private practice, […]
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Industry Discussions What is a Blinded Experiment in Clinical Trials? AQ Sometimes participants and researchers’ expectations can significantly influence the outcomes of clinical trials. Therefore, blinded experiments are conducted to maintain neutrality and objectivity. Blinded experiments ensure that the findings are a direct result of the experiment itself, rather than expectations or preconceived notions.
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Industry Discussions What Is Clinical Research Software and How to Choose the Right One? AQ Clinical research software tools are designed to boost clinical trial efficiency and accuracy. Researchers leverage a range of clinical research software to automate data collection, reducing human error and ensuring consistent data handling. This speeds up data analysis, quickly uncovering
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Industry Discussions How Much Does a Clinical Trial Management System Cost? AQ CTMS cost directly influences decision-making and budget planning for clinical trial research organisations. It is mandatory to accurately assess the costs associated with setup, customisation, maintenance, and user training. It is crucial for a thorough cost-benefit analysis. In fact, transparent and scalable pricing
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Industry Discussions What is the Purpose of Clinical Trials? AQ Clinical trial’s primary purpose is to evaluate the safety, efficacy, and potential side effects of new medical interventions. Whether it is drugs, treatments, procedures, or diagnostic tools, every proposed intervention goes through a series of clinical trials to show and confirm their effectiveness and reliability
Industry Discussions A Quick Guide to Patient Centricity in Clinical Trials AQ Patient centricity is all about making clinical trials more accessible, convenient, and relevant to participants. It is aimed at improving patient engagement and trial outcomes. It’s more than just an ethical imperative. Yes—it is basically a practical necessity in modern clinical trial design.
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Industry Discussions The Ultimate Guide to Understanding What Are Clinical Trials and Studies AQ There are two main types of clinical research: observational studies and clinical trials. Observational Studies monitor individuals in normal settings, collecting information to observe changes over time. Whereas Clinical Trials are focused research studies that assess the impact of a medical,
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Industry Discussions What is a Phase 4 Clinical Trial? AQ Clinical trial Phase 4 is the post-marketing phase of drug development and is conducted after a drug has been approved to be available in the market. It assesses the introduced intervention’s long-term safety, effectiveness, and other aspects in real-world conditions. Related: Clinical Trial Management System Let’s
Industry Discussions What is Phase 3 Clinical Trial? AQ Phase 3 clinical trials, lasting for over 5 years, represent a critical stage in the development of new drugs and medical treatments. They are conducted after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2 trials. The primary goal of Phase 3
Industry Discussions What Is Phase 2 Clinical Trial? AQ Phase 2 clinical trials represent a critical stage in the development of a new drug or treatment. These trials are conducted after the initial safety of the treatment has been confirmed in Phase 1 trials. The primary goals of Phase 2 trials are to evaluate the
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
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
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
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
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,
Industry Discussions What are the 4 Phases of Clinical Trials? AQ The clinical trial research is divided into four distinct phases, each serving a specific purpose in the pursuit of safe and reliable medicines. These phases constitute a structured journey, guiding investigational products from their initial introduction to thorough evaluation and eventual widespread usage. All
Industry Discussions 5 Tips for a Successful Integration of CTMS with EDC AQ Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems play crucial roles in the efficient conduct of clinical trials. Integrating these systems can streamline processes, improve data quality, and enhance overall trial management. Here are some tips for successful integration
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Industry Discussions How to Implement and Use CTMS? AQ The successful implementation and utilisation of a CTMS demand strategic planning and execution backed by ongoing adaptation, feedback loops, and a commitment to leveraging technology for the betterment of medical research. This comprehensive guide will walk you through the key steps involved in implementing and effectively
Industry Discussions What are Decentralized Clinical Trials: Benefits, Challenges, and Implementation AQ Decentralized clinical trials (DCTs), also known as remote or virtual clinical trials, represent a “modern approach” to conducting clinical research in real-time. Over the past few years, Decentralized Clinical Trials (DCTs) have transformed from a promising innovation to a pivotal force shaping the
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Industry News 7 Reasons Clinical Researchers Need to Use CTMS AQ Clinical Trial Management Systems (CTMS) serve as the backbone of clinical trial research progress. Basically, CTMS is a sophisticated software tool which acts as the guiding force behind clinical trials. It’s a catalyst for ensuring efficient and effective trials. Think of it as the
Industry Discussions What is EDC in Clinical Trials? AQ Electronic Data Capture (EDC) is software used in clinical trials to collect and manage data digitally, replacing traditional paper-based methods. It utilizes electronic case report forms (eCRFs), which are web-based questionnaires designed to collect data about study participants. EDC enhances the quality, speed, and accuracy of
A Quick Guide to What is eTMF in Clinical Trial Research Industry Discussions AQ eTMF (stands for electronic Trial Master File) is leveraged for the management of clinical trials in the pharmaceutical, biotechnology, and medical device industries. It offers advantages in terms of efficiency, accessibility, security, and regulatory compliance compared to traditional paper-based TMFs. Ultimately,
