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Pharmacovigilance for Decentralized Clinical Trials

Decentralised clinical trials make clinical trials easier for patients by reducing the need to travel to clinical sites. They are also known as “Direct-to-participant trials” …

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Medical Literature Monitoring

The medical literature is a vital source of information for monitoring the safety and benefit-risk profile of medicinal products. It is a significant source of …

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Responsible Person for Eudravigilance

Responsible Person for EudraVigilance

Introduction EudraVigilance is a centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European …

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Annual Summary Reports for Health Canada: Overview, Requirements, Format and Submission

What is an Annual Summary Report (ASR)? It is a comprehensive assessment of all known safety information for a marketed drug or natural health product. …

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Are ALT & AST Elevations Really Liver Function Tests

Liver biochemical tests are very commonly performed in clinical studies/clinical practice. These tests include: Alanine/aspartate aminotransferases (ALT/AST), Alkaline phosphatase (ALP), Gamma-glutamyl transferase (GGT) Bilirubin, Albumin …

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Serious Adverse Event Reconciliation in Clinical Studies

Serious Adverse Event Reconciliation in Clinical Studies What is Serious Adverse Event (SAE) Reconciliation and why is it required The aim of Good Clinical Practice …

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Liver Injury With Cancer Chemotherapy

Liver Injury with Cancer Chemotherapy

Liver Injury With Cancer Chemotherapy Cytotoxic chemotherapy is frequently associated with serum aminotransferaseelevations that are self-limited and that may subside with continued therapy.However, rare occurrences …

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Drug Induced Liver Injury in Premarketing Clinical Trials

Drug Induced Liver Injury in Premarketing Clinical Trials DILI (Drug Induced Liver Injury) is a rare but potentially fatal adverse drug reaction. DILI is a …

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