Product Development Lifecycle

RECENT BLOGS

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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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