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.

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...

2 min read

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...

3 min read

Regulatory Guidance Monthly Review - Nov 2021

November 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...

3 min read

Regulatory Guidance Monthly Review - Oct 2021

October 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...