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
Author: rakesh@zenovel.com
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
Ensuring Data Integrity: Best Practices and Considerations
INTRODUCTION: There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect to the design, implementation and… Continue reading Ensuring Data Integrity: Best Practices and Considerations
The Road to FDA Success: Zenovel’s Insights and Expertise
The Road to FDA Success: Zenovel’s Insights and Expertise Preparing for FDA interactions can be daunting, filled with uncertainty and misconceptions. Sponsors often find themselves in the dark about what to expect when engaging with the FDA, which can lead to unnecessary stress and setbacks. At Zenovel, we understand the challenges that sponsors face, having… Continue reading The Road to FDA Success: Zenovel’s Insights and Expertise
GMP Audits Unveiled: Behind the Scenes of Ensuring Compliance
Understanding the role of GMP Audits and Its Importance Good Manufacturing Practices (GMP) are a set of guidelines and regulations that ensure products are consistently produced and controlled according to quality standards. GMP audits are comprehensive assessments conducted to verify whether manufacturers are complying with these established practices. They encompass various aspects such as facility… Continue reading GMP Audits Unveiled: Behind the Scenes of Ensuring Compliance
How to Prepare Subject Matter Experts for FDA Inspections
Introduction Facing an FDA inspection can be a nerve-wracking experience for any pharmaceutical company. While many focus on logistics and documentation, one crucial aspect that should not be overlooked is preparing your Subject Matter Experts (SMEs) for the inspection. SMEs, who possess in-depth knowledge of your front-line operations, can unintentionally provide information that may harm… Continue reading How to Prepare Subject Matter Experts for FDA Inspections
Ace Your FDA Inspection with Zenovel
Ace Your FDA Inspection with Zenovel Understanding FDA Inspections Before we dive into the specifics of this blog, let’s take a moment to understand the significance of FDA inspections. The Food and Drug Administration (FDA) is responsible for safeguarding public health by ensuring that pharmaceutical manufacturers comply with strict regulations and guidelines. Routine inspections are… Continue reading Ace Your FDA Inspection with Zenovel
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