Gary Keeler

2 min read

The Regulatory Constraints in Making Your LDT/CDx Partnership Choices in China

Our previous blog discussed the emerging trends for the companion diagnostics (CDx) regulations in China. There have been several developments since then, including the introduction of Laboratory-Developed Tests (LDTs) in China through pilot...

Read More

1 min read

HHS Declares​ Emergency Use Authorization for Use of In Vitro Diagnostics for Detection of Monkeypox Virus

WHAT DOES THIS MEAN? Monkeypox virus is a zoonotic infection, caused by Orthopoxvirus genus of the Poxviridae family like variola virus (the...

Read More

4 min read

Veranex Risk Based Monitoring Business Delivery Model – A Case Study

Veranex has successfully designed and implemented a “5D Framework” to support its Risk Based Monitoring service delivery model. The 5 components are:...

Read More

1 min read

Veranex Risk Based Monitoring (RBM) Business Delivery Model With 5D Framework

Veranex has successfully designed and implemented a “5D Framework” to support its RBM service delivery model, in order to create a better...

Read More

2 min read

A Data Management Perspective: How Are Device Trials Different from Drug Trials?

The many articles discussing the difference between drug and device trials are often coming from a regulatory perspective on how device trials are...

Read More

1 min read

Risk Based Monitoring & Technology Driven Solutions – Veranex Hosted Sponsor Visit at Bangalore, India Office

Veranex is pleased to have hosted a key meeting with a Generics & Biosimilars Sponsor at the Bangalore, India office on May 31st, 2022. This forum...

Read More

5 min read

Understanding the ROI of Human Factors Engineering

By Matt Gottschalk

Read More

2 min read

Meeting Early Phase Study Challenges – a Data Management Perspective

First-in-Human studies are a discovery point, which can decide the fate of a compound as well as lay the groundwork for subsequent phases of a...

Read More

2 min read

How COVID Changed the Diagnostic Industry – for Better

It goes without saying that the pandemic has disrupted all aspects of our lives especially the healthcare system, including the diagnostic industry....

Read More

2 min read

Looking Forward – AACC 2022 Round Up

Only a few weeks until AACC 2022 in Chicago, the largest clinical diagnostics conference in the world. Ahead of the conference, I share some thoughts...

Read More