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Regulatory Guidance Review - April 2019

May 8, 2019

Latest Updates from FDA & EMA

April 2019 Updates

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  and European Medicines Agency (EMA) 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 April 2019.

 

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5 Ways To Transform Your Work Space For Inspiration and Creativity

May 6, 2019


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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Regulatory Guidance Review

March 28, 2019

Latest Updates from FDA & EMA

March 2019

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  and European Medicines Agency (EMA) 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 March 2019.

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5 Best Practices for Making Virtual Teams Work

March 26, 2019

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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Team Veristat Raised over $50K To Support Rare Cancer Research

February 5, 2019

Our Challenge:   Join the Battle to Beat Rare Cancers

Our Impact:   $150K Raised to Support Rare Cancer Research

For a fifth consecutive year, Team Veristat accepted this challenge in the 2019 Boston #cycleforsurvival event!   We exceeded our goal of raising $50,000 to support rare cancer research.

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Beating Rare Cancers Requires Your Help - JOIN THE BATTLE TODAY!

January 11, 2019

As a scientifically oriented and impactful full-service clinical research organization (CRO) that is committed to partnering with pharmaceutical, biotechnology, and medical device firms to advance their therapies throughout the entire clinical development and regulatory submission process,  Veristat works each day with a focus on improving the lives of patients with rare cancers

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More Seats at the Table | The Growth of Female Leadership in Healthcare

December 5, 2018

As a Talent Acquisition Consultant for Veristat, I receive many cover letters and resumes from candidates each day. I am often blown away by the experience, knowledge, and expertise of these individuals and always hope to match their skill sets to one of our current openings. 

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When Veristat Walks – Cancer Runs

October 3, 2018

In 1964, a child’s chance of surviving the most common form of Leukemia was 3%.  Today it has increased to 91%!  

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What  to Know Before Considering an Adaptive Design Clinical Trial

August 31, 2018

By John Balser, PhD, President, Mark Chang, PhD, Senior Vice President, and Robin Bliss, PhD, Director

The Food and Drug Administration (FDA) has started encouraging the use of adaptive designs for clinical studies. In essence, adaptive designs allow prospectively planned modifications to a clinical trial based on interim data, provided scientific validity (the ability to draw sound inferences) and data integrity (credibility and reproducibility) are preserved. 

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Is Your Complex NDA/MAA Submission Missing One of These Key Elements?

August 21, 2018

By Martha Plaza, MBA; Amanda Truesdale, MA, MBA; and Kimberly Newton, MA. 

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