2 min read
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...
4 min read
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...
1 min read
For a fifth consecutive year, Team Veristat accepted this challenge in the 2019 Boston #cycleforsurvival event! We exceeded our goal of raising
1 min read
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...
2 min read
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...
1 min read
In 1964, a child’s chance of surviving the most common form of Leukemia was 3%. Today it has increased to 91%!
3 min read
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...
3 min read
Veristat has experience in preparing more than 120 marketing applications. Our exposure to in creating new drug applications (NDAs) and marketing authorization applications (MAAs) has taught us two main lessons:
3 min read
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?
2 min read
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.