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Pharmacovigilance in Clinical Research
Safety First. Every Case Assessed and Reported.
Pharmacovigilance (PV) is the science and set of activities concerned with the detection, assessment, understanding, prevention, and management of adverse effects and other medicine-related safety problems.
In clinical research, pharmacovigilance plays a critical role in protecting clinical-trial participants and patients, and in ensuring that emerging safety information is appropriately assessed and reported.
Our approach follows a structured case-handling workflow, from the moment safety information is received to case closure, with quality review built into the process.
Our Pharmacovigilance Services
Detect. Assess. Report.
We work closely with sponsors, investigators, and research teams so that safety information from clinical research is captured, assessed, and reported appropriately, protecting the people who take part in studies.
Detection
Identifying adverse effects and other medicine-related safety problems as safety information is received.
Assessment
Evaluating each case for seriousness, causality, and expectedness.
Understanding
Interpreting safety data to understand how and why safety problems arise.
Prevention
Using safety findings to reduce the risk of harm to participants and patients.
Management
Handling each case through follow-up and closure, with regulatory reporting where applicable.
Participant & Patient Protection
Ensuring that emerging safety information is appropriately assessed and reported to protect clinical-trial participants and patients.
How Every Case Is Assessed
Three Questions for Each Safety Case.
During medical review, each case is assessed for seriousness, causality, and expectedness.
Seriousness
Does the event meet the criteria that classify it as serious?
Causality
Is the medicine likely to be related to the event?
Expectedness
Is the event consistent with the known safety information for the product?
Pharmacovigilance Workflow
From First Report to Case Closure.
Each case moves through the same steps, so that nothing is missed between receipt and closure.
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1
Safety Information Received
Adverse-event and other safety reports arrive from trial sites and other sources.
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2
Case Intake
Each report is logged so it can be tracked from the moment it arrives.
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3
Case Validation
The report is checked for the minimum information needed to process it as a valid case.
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4
Data Entry
Case details are entered into the safety database.
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5
Medical Review
A medical reviewer evaluates the clinical content of the case.
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6
Seriousness, Causality & Expectedness Assessment
The event is assessed against the three questions above.
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7
Coding
Events, medicines, and other terms are coded using standard dictionaries.
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8
Quality Review
Cases are checked for accuracy and completeness before they move forward.
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9
Regulatory Reporting, Where Applicable
Reportable cases are submitted to the relevant authorities within the required timelines.
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10
Follow-Up
Additional information is requested to complete or clarify the case.
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11
Case Closure
The case is closed once assessment, reporting, and follow-up are complete.
Protecting clinical-trial participants and patients is the central purpose of pharmacovigilance, from the first safety report through to case closure.
Medical review, coding, and quality review help ensure that each case is assessed carefully and that emerging safety information is reported appropriately.
Frequently Asked Questions
Pharmacovigilance is the science and set of activities concerned with the detection, assessment, understanding, prevention, and management of adverse effects and other medicine-related safety problems.
It protects clinical-trial participants and patients, and ensures that emerging safety information is appropriately assessed and reported.
The information goes through case intake and case validation, the details are entered as data, and the case then moves on to medical review.
Each case is assessed for seriousness, causality, and expectedness, and is then coded and checked in a quality review.
Regulatory reporting is carried out where applicable, after the case has been assessed and has passed quality review.
Follow-up is carried out to complete or clarify the case, and the case is closed once the process is complete.