Patient Safety and Pharmacovigilance
Insights and guidance to address patient safety through all stages of clinical research
As global regulatory frameworks evolve, our pharmacovigilance and drug safety teams can guide clients to understand and address the latest updates to identify, evaluate, and manage risk throughout the drug and device development process.
COVID-19 vaccines: Post-authorisation safety surveillance
This whitepaper explores the multifaceted challenges of COVID-19 post-authorisation safety surveillance studies and how business intelligence tools can benefit these efforts.
A guide to safety data migrations
Choosing the best approach to maintain data integrity
This whitepaper outlines the key advantages and disadvantages of manual data migrations, technical data migrations, and E2B data migrations.
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Pharmacovigilance Affiliate Model: Why outsourcing makes sense at an affiliate level
In this whitepaper, we consider the benefits of adopting an outsourced model for pharmacovigilance that is centrally managed and geographically dispersed, ensuring efficient and compliant delivery whilst retaining the effectiveness of a local presence. We also explore the current challenges associated with managing local affiliate pharmacovigilance activities and potential ways to overcome these.
Understanding the Periodic Benefit-Risk Evaluation Report
How careful preparation of the initial PBRER sets up future success
The International Conference of Harmonization ICH-E2C (R2) requires all license holders of new medicinal products to submit a Periodic Benefit-Risk Evaluation Report (PBRER). Gain insight about best practices that can be implemented during the process of creating an initial PBRER.
Sponsor and CRO pharmacovigilance and safety alliances
This whitepaper outlines the best practices and model options for ensuring success when outsourcing pharmacovigilance and patient safety services.
Evolution of the Pharmacovigilance System Master File
This whitepaper provides an overview of the Pharmacovigilance System Master File (PSMF) and how it has evolved over the last ten years, both inside and outside of the European Union.
Taking safety reporting to the next level with automation
Our solution ensures compliance through automation. Based on an innovative cloud-based system and featuring automated and configurable business rules, it enables you to gain visibility into the safety profile of an investigational product throughout its lifecycle.
Patient safety and pharmacovigilance blogs and media contributions
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Blog: Limiting Potential Carcinogenic Risk in Drug Development with Reliable Predictions
ICON's Mgr, Nonclinical Safety Assessment, Drug Development Consulting discusses the challenges & opportunities of in silico analysis in toxicology.
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Blog: EMA ISO IDMP - The path forward
The EMA is implementing the standards developed by the ISO for the IDMP.
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Blog: The final countdown to the overhaul of Pharmacovigilance in the EEA
In October, the European Medicines Agency (EMA) released their much anticipated Go-Live plan following input from all of the National Competent Authorities in the European Economic Area (EEA).
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Blog: New EudraVigilance System
Resulting changes to reporting, downloading and analysis of data in EEA
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Blog: Ensuring safety and compliance: The essentials of outsourcing pharmacovigilance
In this blog, we delve into the rationale behind outsourcing pharmacovigilance activities at the affiliate level and explore the essential requirements for appointing local persons for pharmacovigilance (LPPVs).
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Blog: Safety reporting in LATAM is changing, are you ready?
LATAM is evolving to electronic safety reporting and it is essential to be prepared for it.
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Blog: ISO 14155: Increased emphasis on clinical data continues to trend for medical device regulations
Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.
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Blog: How to ensure your trial data and patients remain safe during COVID-19
Adhering to best practices regarding patient data privacy remains important during times of crisis as more sponsors, sites and patients increasingly rely on remote communications.
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