Blog | Veristat Insightful Perspectives

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.

 

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Sustaining Success Across the Global Pharmacovigilance Landscape

Setting the Scene

 

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Regulatory Guidance Monthly Review - April 2022

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 and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in April 2022.

 

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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 phase I/II study.

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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

 

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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 device development and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in February 2022.

 

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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 device development and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in January 2022.

 

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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 device development and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in December 2021.

 

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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 device development and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in November 2021.

 

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