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Regulatory Guidance Monthly Review - December 2019

January 7, 2020

December 2019 



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 in December 2019.

 

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Regulatory Guidance Monthly Review - November 2019

December 11, 2019

November 2019 Updates from FDA 


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 in November 2019.

 

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Understanding When to Submit an IND Application to the FDA

November 20, 2019

An Interview with Kevin Hennegan, Senior Regulatory Strategist, Veristat

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Selecting the Right EDC System for a Clinical Program

November 14, 2019

Understanding the Various Considerations for EDC Selection

An Interview with  Kathleen Boruchowski, Director of Data Management, Veristat 

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Regulatory Guidance Monthly Review - October 2019

November 6, 2019

October 2019 Updates from FDA 


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 in October 2019.

 

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Light The Night Walk 2019 | Veristat Walks in Boston & Toronto

October 23, 2019

Four Years and Counting....

Veristat is proud to have participated in the Leukemia & Lymphoma Society’s Light The Night Walk for the fourth year in a row. This year, for the first time, Veristat participated in two walk locations: Boston and Toronto!

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Evolving Risk-Based Monitoring to Improve Clinical Studies

October 11, 2019

An Interview with Dunya Botetzayas, RN, Senior Director of Clinical Monitoring at Veristat

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Regulatory Guidance Monthly Review - September 2019

October 2, 2019

September 2019 Updates from FDA 


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 in September 2019.

 

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What Matters Most in the Clinical Study Feasibility Process

September 26, 2019

An Interview with Dr. Deepen Patel, Vice President of Medical Affairs at Veristat

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Regulatory Guidance Monthly Review - August 2019

September 3, 2019

August 2019 Updates from FDA 


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 in August 2019.

 

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