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The Role of PRISMA in Evidence-Based Medicine
Introduction Systematic reviews present comprehensive data about a research question and are regarded as the gold standard...
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Clinical Trials: Monitors and Research Coordinators
In the intricate world of clinical trials, the relationship between a clinical trial monitor and a research...
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Improving Efficiencies in Data Collection: Electronic Source
Introduction to Source Documentation Source documentation is the initial documentation of clinical trial data, regardless of format...
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Good Documentation Practices for a Clinical Trial
Source documents are essential documents that are required for Good Clinical Practice. It is the first place...
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How to Start a Clinical Trial: 10 Steps to Meet FDA Standards
Starting a clinical trial is a critical milestone in bringing new medical products to market. Whether you...
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Rethinking Representation in Clinical Research – Who’s in the Study?
Introduction The underlying principle of a clinical study is to assess the safety and efficacy of an...
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Patient-Reported Outcome (PRO)
“What matters is this – will it help patients?” ~ Bill Cook Introduction To ensure that patients...
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The Impact of GCP R3 on Your Trial Master File
Introduction The third revision (R3) of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) was...
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5 Main Components of a MDR Clinical Evaluation Report (CER)
To comply with the European Union Medical Device Regulation (MDR), medical device manufacturers are required to conduct...
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Deviations in Medical Device Clinical Studies
Introduction During the conduct of a study, there may be instances where the study protocol is not...
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Strategizing Biocompatibility Evaluation in Changing Manufacturing Environments: When do you Approach Subject Matter Experts?
In a dynamic manufacturing environment, changes are inevitable. Ensuring medical device safety is very crucial, particularly when...
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Developing a Quality System / Standard Operating Procedures for Conducting Medical Device Clinical Trials
Introduction The development of quality system procedures or standard operating procedures (SOPs) for conducting clinical trials of...
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