Blog | Veristat, The Science-First CRO

2 min read

The New EU Framework for In Vitro Diagnostics Enters into Application

The In Vitro Diagnostics Regulation (IVDR, EU 2017/746) enters into application in the European Union (EU) on 26 May 2022.

2 min read

A Paradigm Shift in Monitoring Clinical Trials

What we know as work has experienced a major transformation. This shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.

1 min read

Sustaining Success Across the Global Pharmacovigilance Landscape

Working in the pharmacovigilance area and protecting the safety of patients is challenging. With Veristat, you’ll bring more confidence to your post-marketing pharmacovigilance and safety surveillance for greater peace of mind.

5 min read

Regulatory Guidance Monthly Review - April 2022

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...

1 min read

Is it Possible to Gain Regulatory Approval Following a Single-Arm Study?

In this case study example - yes.

Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm...

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Veristat Joined the Battle Again - in 2022

Another Successful Cycle for Survival Ride Raising $90K To Support Rare Cancer Research

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Strategic Resourcing | Another Way To Help Sponsors

Staffing solutions to accelerate clinical development milestones and support study success

2 min read

Regulatory Guidance Monthly Review

February 2022 

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical...

3 min read

Regulatory Guidance Monthly Review - Jan2022

January 2022 

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical...

3 min read

Regulatory Guidance Monthly Review - Dec 2021

December 2021 

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical...