Blog | Veristat Insightful Perspectives

Clinical Trial Conduct During COVID-19 Pandemic Response

Key Lessons Learned during the First Month of the COVID-19 Pandemic Response 

As we are well-rooted in the response phase of the COVID-19 pandemic, we have seen a flurry of sponsors looking through their pipelines to find either approved or investigational products that could help treat, diagnose or prevent COVID-19.   As such, Veristat spent the first four weeks of the pandemic response supporting five clinical research programs for COVID-19 vaccines and treatments.   And, we are rapidly fielding daily requests for more programs.   

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MRHA Guidance for Clinical Trials During COVID-19 Outbreak

MHRA Guidance On Clinical Trial Conduct During COVID-19 Pandemic 

 

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Regulatory Insights on COVID-19 Updates From FDA | 31 March 2020

FDA UPDATES -  For Sponsors with Products Intended to Treat Indications Other than COVID-19

 

In this unique time, with many health authorities, governments and pharmaceutical companies focused on the global pandemic and how to prevent, diagnose and treat COVID-19, it is important to remember the number of therapies currently in development or already approved for the multitude of other diseases affecting people worldwide.  FDA has issued several press releases and guidance that affect Sponsors running or planning clinical studies, those planning marketing applications and those with products already on the market.  We summarize here valuable information that is important for drug and biologic companies to be aware of as they continue to try to make these therapies available to patients. 

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Covid-19 Update from FDA | Conduct of Clinical Trials During Covid-19 Outbreak

FDA Guidance On Clinical Trial Conduct During COVID-19 Pandemic -  18 March 2020 

 

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Regulatory Guidance Monthly Review - February 2020

February 2020 



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 February 2020.

 

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Regulatory Guidance Monthly Review - January 2020

January 2020 



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 January 2020.

 

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Understanding When to Submit an IND Application to the FDA

An Interview with Kevin Hennegan, Senior Regulatory Strategist, Veristat

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Selecting the Right EDC System for a Clinical Program

Understanding the Various Considerations for EDC Selection

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

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5 Ways To Transform Your Work Space For Inspiration and Creativity


Person at Desk UninspiredPicture this: it’s mid-afternoon on a Thursday, and you’re at your desk. You have important work to do, but your attention is wandering, and you can’t seem to get the motivation you need to get anything done.

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5 Best Practices for Making Virtual Teams Work

At Veristat our need to manage and work in virtual environments continues to increase. With six offices globally and nearly 300 employees, we are building teams with members spread out in different physical locations. Our geographically dispersed teams continue to grow with our increasing remote employee population; In fact remote workers are our largest growing population with nearly 30 % of our employees working from their home offices.

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