White Paper
Sponsor and CRO Pharmacovigilance and Safety Alliances
Outsourcing pharmacovigilance is a standard business practice in a rapidly expanding market segment. In this new whitepaper, PRA’s Sabine Richter…
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White Paper
Fact Sheet
Endpoint Adjudication Services
PRA uses a proprietary electronic Endpoint Adjudication Tool that semi-automates many steps in the end-to-end endpoint adjudication workflow. Some of…
White Paper
PBRERs – Pitfalls and Misconceptions
Following the release of ICH guideline E2C (R2) Step 5 on the Periodic Benefit-Risk Evaluation Report (PBRER) in January 2013 and EU GVP Module VII –…
White Paper
Pharmacovigilance Oversight: Outsourcing QPPV Services
This white paper provides insight into considerations when outsourcing Qualified Person for Pharmacovigilance (QPPV) services. It also touches upon…
White Paper
Literature Surveillance
Literature surveillance is an important tool in the suite of monitoring activities to ensure the safety of medicinal products. The success of…
Blog
Pharmacovigilance and its Place in the Industry
Pharmacovigilance ensures patients can trust the people handling their healthcare. Learn more about the importance of patient safety and what we’re…
White Paper
Transparency and Reliability
Adjudication can be a tool to improve the confidence of trial data, although it is essential to have a clear and defined process. Historically,…
Fact Sheet
Pharmacovigilance & Patient Safety Solutions in Response to COVID-19
The COVID-19 pandemic poses a critical challenge to individuals, caregivers and healthcare systems worldwide. This challenge extends directly to the…
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Pharmacogenomics
Optimize drug therapy with respect to the patient’s genotype, ensuring maximum drug efficiency with minimal adverse effects.
Fact Sheet
Pharmacogenomics (PGx) Fact Sheet
Pharmacogenomics aims to develop rational means to optimize drug therapy with respect to the patient’s genotype, ensuring maximum drug efficiency…