Trusted Resource for Clinical Trials, Protocols & Progress
Remote Due Diligence: Best Practices Best Practices for Conducting Remote Due Diligence in Clinical Trial Vendor Assessments Introduction: Why Remote Due Diligence Is Increasing The COVID-19 pandemic accelerated the shift toward remote oversight in clinical research. Sponsors and CROs increasingly rely on virtual tools to conduct vendor assessments, audits, and qualifications without physical site visits….
Role of NABH Accreditation in Clinical Trial Site Selection in India How NABH Accreditation Influences Clinical Trial Site Selection in India Introduction Site selection is a critical determinant of clinical trial success, especially in a diverse and complex healthcare environment like India. One key metric that has gained increasing importance is NABH accreditation. The National…
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Regulatory Acceptance of Adaptive Changes Understanding Regulatory Acceptance of Adaptive Modifications in Clinical Trials Introduction: Balancing Flexibility and Integrity Adaptive designs allow clinical trials to evolve based on accumulating interim data. Mid-trial modifications—such as sample size re-estimation, dropping or adding arms, or adjusting randomization ratios—can improve efficiency and patient safety. However, regulators require strict safeguards…
EU Requirements for Non-EU Sponsors in Clinical Trials Understanding EU Clinical Trial Requirements for Non-EU Sponsors Non-EU sponsors play a significant role in conducting clinical trials across Europe, reflecting the EU’s position as a key hub in global drug development. However, sponsors based outside the EU must comply with specific legal, regulatory, and operational obligations…
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Role of UK Research Ethics Committees (RECs) in Clinical Trials Research Ethics Committees and Their Role in UK Clinical Trials Research Ethics Committees (RECs) are a fundamental component of the UK’s clinical research governance system, ensuring that the rights, safety, dignity, and well-being of participants are prioritised. Operating under the Health Research Authority (HRA), RECs…
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What Changes Are Allowed Mid-Trial? Adaptive Modifications Permitted During Clinical Trials Introduction: The Concept of Adaptive Modifications Adaptive trial designs allow pre-specified modifications during the course of a study, based on interim data. The goal is to enhance efficiency, ethical oversight, and scientific validity without compromising trial integrity or inflating Type I error. Regulators such…
How CFDA Transition to NMPA Changed Clinical Trials The Transformation of Clinical Trials in China: From CFDA to NMPA Introduction The transition from the China Food and Drug Administration (CFDA) to the National Medical Products Administration (NMPA) in 2018 marked a pivotal moment in the modernization of China’s clinical trial and regulatory landscape. For decades,…
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SOP for Pediatric Safeguards (Age-Appropriate Procedures/Assent) { “@context”: “https://schema.org”, “@type”: “Article”, “mainEntityOfPage”: { “@type”: “WebPage”, “@id”: “https://www.clinicalstudies.in/sop-for-pediatric-safeguards-age-appropriate-procedures-assent” }, “headline”: “SOP for Pediatric Safeguards (Age-Appropriate Procedures/Assent)”, “description”: “This SOP defines standardized procedures for pediatric safeguards in clinical trials, including age-appropriate assent, parental consent, and risk minimization strategies. It ensures compliance with FDA, EMA, CDSCO, WHO, and…
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Benefits of Central Lab Standardization: Lessons Learned from Global Audits Standardizing Central Laboratory Practices in Global Clinical Trials Introduction: The Role of Central Labs in Multinational Clinical Trials Central laboratories have become an essential part of global clinical trial infrastructure. Their appeal lies in their ability to provide standardized testing, centralized data processing, and streamlined…
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Adaptive Trial Designs in Indian Clinical Programs: Regulatory Perspectives and Emerging Practices Understanding Adaptive Trial Designs in India’s Regulatory and Clinical Research Landscape Introduction Adaptive clinical trials have revolutionized how new medical products are evaluated, offering flexibility and efficiency in response to accumulating data. In India, the regulatory acceptance of adaptive designs is gaining traction,…
