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Regulatory Guidance Review

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

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

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!

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

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

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

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?

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

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Key Strategies for Overcoming Data Analysis Difficulties During NDA/MAA Submissions

By Amanda Truesdale, MA, MBA, VP Biometrics

When database locks are delayed, or regulatory agencies request additional analyses for new drug applications (NDAs) or marketing authorization applications (MAAs), it seems there is no alternative but to take a hit to the timeline — or is there?

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Streamline the Medical Writing Process for Simultaneous Submissions

By Kimberly Newton, MA, Senior Director Medical Writing

When a team faces multiple submissions in a short timeframe or even simultaneous submissions, uncertainty over timeline organization and the best way to utilize medical writers can be paralyzing.

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