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Petri Dishes with Experiment

Pharmacovigilance

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Strategic Services to Advance Your Goals

Pharmacovigilance plays a critical role in protecting patient safety by detecting, assessing, and preventing adverse effects throughout a product’s lifecycle. Our Pharmacovigilance services help companies establish and maintain compliant safety processes, ensuring timely reporting, risk management, and regulatory adherence. Whether supporting clinical development or post-marketing surveillance, we provide tailored solutions to meet evolving safety requirements while optimizing efficiency. 

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Pharmacovigilance Services

Aggregate safety report preparation 
Signal detection and risk management 
Pharmacovigilance system master file (PSMF) maintenance 
Safety data exchange agreements 
 
Qualified person for pharmacovigilance (QPPV) services 
Adverse event reporting and follow-up 
Literature surveillance 
 
Individual case safety report (iCSR) management 
Pharmacovigilance auditing and inspections 
Safety database management 
 
Regulatory intelligence and compliance 

Technology Solutions 

We are thought leaders on the use of automation/logic-based programming and AI for patient data and patient-facing documents. Innovations include: 

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AgileWriter.ai™

First-in-class AI tool for composing and managing clinical trial documents

 › ​Learn more

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Quillyx™

eCTD templates that pass technical validation of submissions

 › ​Learn more

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VeriSync™

Co-authoring sync monitoring tool for Microsoft Word

 › ​Learn more

Synterex also is a Microsoft Cloud AI Partner, which positions us to work closely with product management at one of the largest tech companies in the world to advocate for clients and deliver best-in-class user experiences.

Learn more about how we're leveraging technology for the good of the patient.

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