ROOT CAUSE ANALYSIS IN CLINICAL RESEARCH Clinical trials are intricate endeavors aimed at bringing innovative therapies to market, but quality concerns persist for many Contract Research Organizations (CROs). Regulatory audits often uncover inadequate handling of failures and deviations. This article emphasizes the importance of Root Cause Analysis (RCA) as a tool to investigate and resolve… Continue reading ROOT CAUSE ANALYSIS IN CLINICAL RESEARCH
Category: GCP
Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)
Abstract: For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes. Regulatory guidance like ICH, and FDA encourage sponsors to adopt advanced concepts of monitoring in… Continue reading Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)
Mastering Inhalation Studies: A Closer Look at Challenges and Solutions
Introduction: In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct. Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This Article sheds light on Zenovel’s recent involvement in the monitoring of three studies of Indacaterol/Glycopyrronium conducted… Continue reading Mastering Inhalation Studies: A Closer Look at Challenges and Solutions
FAQ GxP Quality Guidelines
GxP Quality Guidelines and Regulations: Frequently Asked Questions: What happens when GxP regulations are not followed? Noncompliance with GxP regulations can result in significant repercussions for sponsors and their collaborators. This could include financial penalties and legal actions. If a sponsor fails to adhere to federal GxP regulations to a significant extent, endangering public safety,… Continue reading FAQ GxP Quality Guidelines
Optimizing Liposomal Amphotericin-B BE Studies
Challenges and Expert Monitoring in Liposomal Amphotericin-B BE Studies Introduction Liposomal Amphotericin-B is a critical antifungal medication that requires careful attention during Bioequivalence (BE) studies. These studies aim to demonstrate the similarity of a generic liposomal Amphotericin B formulation to the reference drug in terms of pharmacokinetics. Zenovel, with its extensive experience in monitoring Amphotericin… Continue reading Optimizing Liposomal Amphotericin-B BE Studies
Enhancing Clinical Studies with GCP Audit and Monitoring
Enhancing Clinical Studies with GCP Audit and Monitoring Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance… Continue reading Enhancing Clinical Studies with GCP Audit and Monitoring
GCP Compliance in Clinical Research
GCP Compliance in Clinical Research We all know very well what GCP truly means in clinical research accurate and credible data plus rights, Integrity, and confidentiality of trial subjects. i.e., “Quality Data + Ethics= GCP” So, what GCP should lead………………” Patient rights, Safety, and Well-being” We certainly always talk about GCP compliance during… Continue reading GCP Compliance in Clinical Research
Importance and Purpose of Clinical Research Monitoring
Introduction: There is no doubt that medical science is reaching new heights every day. All processes related to FDA approval are becoming more advanced, systematic, and quick. The same is true for clinical trial monitoring – a critical activity in drug development and marketing approval to ensure the quality of the research data and the protection of… Continue reading Importance and Purpose of Clinical Research Monitoring