Veranex Blog

Safety

1 min read

Harnessing AI Technology to Identify Adverse Events with Great Accuracy and Efficiency

Yurii Kartashov: Apr 29, 2024 12:46:35 PM

The use of technology in clinical trials, including artificial intelligence (AI), is evolving rapidly. According to the consulting firm Gartner, “The...

AI Trial Strategy Safety
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2 min read

Prioritizing Patient Safety and Fostering Innovation with the MHRAs New Roadmap for Medical Devices

Heidi Jerman: Mar 8, 2024 9:15:15 AM

On January 9, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) released a regulatory framework – Roadmap towards...

EU Regulatory Device CRO Safety
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5 min read

Nanomaterials in Medical Devices: Biological Risks and Methodology for Biocompatibility Assessment

Veranex: Sep 28, 2023 4:05:23 AM

Introduction Nanomaterials, tiny scientific wonders that are invisible to the naked eye, hold the potential to revolutionize numerous facets of our...

FDA Regulatory Biocompatibility Safety
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5 min read

Medical Device Vigilance: Important Considerations to Comply With the EU MDR

Gary Keeler: Apr 7, 2023 4:34:31 PM

Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...

EU Regulatory Quality Safety
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2 min read

Basics of Drug Safety: Importance of Case Processing in Pharmacovigilance (PV)

Gary Keeler: Feb 9, 2023 4:08:56 PM

Case processing in pharmacovigilance is a fundamental activity to support safety surveillance in clinical trials. Along with an anticipated...

FDA Regulatory Biopharma Safety
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3 min read

Plan to Mitigate Challenges in Pharmacovigilance and Drug Safety

Gary Keeler: Jun 15, 2022 11:44:22 AM

Biopharmaceutical companies worldwide are developing better and most cost-effective medicines at an unprecedented rate. With billions of dollars...

Biopharma Trial Strategy Safety
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