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.
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 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.
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?
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.
by Martha Plaza, MBA, Project Director, Regulatory Submissions
No two New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs) are the same. However, they all have common aspects that create the opportunity for streamlined operational tips.