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" I am very impressed with how quickly inVentiv Clinical works. Your whole team has been in step with us all along the way."
— Vice President,
Pharmaceutical Company
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| inVentiv Clinical Expands Operations to Emerging Latin American Region |
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| The global pharmacovigilance landscape is a continuous, complex interplay between patients, healthcare professionals, pharmaceutical companies and regulatory authorities. The volume of suspected adverse event case reports received can be unpredictable and variable. To stay competitive in today’s landscape, Pharmaceutical and Biotech companies need access to the right resources for cost-efficient global delivery of end-to-end drug safety data management and pharmacovigilance services. |
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| Through our partner in India, Sciformix, inVentiv Clinical provides end-to-end safety data management services, from case intake through periodic regulatory reporting and medical evaluation, in conformance with all applicable regulatory requirements and Standard Operating Procedures: |
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Case Intake: Trained associates receive and process spontaneous and clinical trial AEs from variety of sources. |
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Case Entry & Medical Coding: Reports are triaged, entered into a database and coded in accordance with global standards – WHO, MedDRA® |
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Seriousness, Causality, & Expectedness Assessment: Cases are assessed by trained associates in accordance with SOPs. |
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Safety Narrative Writing: Clear, concise and accurate narratives are written. |
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Medical Review: Experienced medical professionals review AE reports to ensure accuracy of assessment and overall data consistency. |
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Quality Review & Assurance: Independent quality checks are performed. |
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Regulatory Reporting: FDA 3500A, CIOMS-I, periodic reports, PSURs are written, as required, in compliance with US FDA, EU guidelines. |
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| Download our Pharmacovigilance Fact Sheet |
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