Patient Narratives: Writing Process & Example with Key Components

Patient narratives are brief summaries of specific events experienced by patients during the course of a clinical trial. They are a required component of clinical study reports (CSRs) and pharmacovigilance activities and aid in the evaluation of the safety profile of a drug. Here we will briefly review the narrative writing process and provide a patient narrative example. Patient Narrative Writin ...

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EMA Policy 43: Revised Policy on Access to Documents

By Kristin McDougall, Work Stream Lead, Transparency & Disclosure The European Medicines Agency (EMA) recently placed a new notification on its website revising who can request access to unpublished documents under the scope of Policy 43. EMA Policy 43 pertains to the legal right of access to documents that were sent to the EMA for now-approved medicinal products for human and veterinary use. ...

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Clarifications Concerning Health Canada’s Draft Guidance on the Public Release of Clinical Information – Part III

Over the past two weeks we have shared our questions and clarifications concerning Health Canada's draft guidance on the Public Release of Clinical Information. Following is Part III, which represents the conclusion of this series. Please click here to read Part I. Please click here to read Part II. Clarifications Concerning Health Canada's Draft Guidance on the Public Release of Clinical Informa ...

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Clarifying Health Canada’s Public Release of Clinical Information Draft Guidance – Part II

Last week we shared Part I of our three-part series on the questions and clarifications we submitted to Health Canada regarding their draft guidance on the Public Release of Clinical Information. Many thanks to everyone who commented with their insight. Following is Part II. Please leave your comments below to keep the conversation going. Health Canada's Public Release of Clinical Information: Ou ...

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Questions Regarding the Public Release of Clinical Information Draft Guidance – Part I

Synchrogenix’s experts and thought leaders have a pulse on the future impact of decisions made today, which is why we offer comments on global draft guidances on behalf of life science companies worldwide. Nirpal Virdee, Synchrogenix's Director of Client Services and Technology, recently submitted feedback to Health Canada regarding their draft guidance on the Public Release of Clinical Informatio ...

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