Pharmacovigilance
Quanticate offers a range of pharmacovigilance services throughout all phases of clinical development and post-marketing.
There is advantage in centralising all safety data, clinical data, analysis and reporting with one provider. By combining Quanticate’s substantial biometrics, medical writing and pharmacovigilance expertise, we offer a fully compliant and high quality complete package of pharmacovigilance services.
Our
goal is to help our customers meet the strict regulatory requirements, along with managing the risk-benefit profile of products, in order to maximise product potential, whilst ensuring patient safety.
From outsourcing of individual activities, to the set-up and management of an effective and efficient global pharmacovigilance system, Quanticate provides solutions specific to the requirements of our customer’s organisation and products.
Pharmacovigilance services include:
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Adverse Event Case Processing
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Expedited Case Reporting
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EudraVigilance & Electronic Reporting
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Safety Data Management & Global Safety Database
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Signal Detection & Evaluation
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Pharmacovigilance Report Preparation & Submission
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Literature Search & Review
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EU Qualified Person for Pharmacovigilance
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Medical Monitoring
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Pharmacovigilance Quality Assurance