Blog | Veristat Insightful Perspectives

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.

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.

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.

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. 

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

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.

With the summer in full swing, vacations and long weekends by the pool are top of mind.

Although we all have the best intentions to use our paid time off each year, it is also not a secret that Americans are truly terrible at taking time off.  According to Project: Time Off, 52% of American employees reported having unused vacation days at the end of 2017.

Understanding Why Creative Solutions Are Necessary

With last month’s celebration of Rare Disease Month and specifically, Rare Disease Day, awareness of the research challenges faced by patients and pharma companies are especially high during this season.

If you heard the phrase, “You have cancer,” what would be your response?