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.
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?
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.
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.
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.
March 21, 2018
Have you ever tried to paint a room in the dark? Probably not, right?
Why would anyone go through the trouble of getting the supplies and putting in the effort to attempt a job well done if they couldn’t see their progress along the way? Just the same, why would anyone turn their career over to the annual performance review process?
January 10, 2018
CYCLE FOR SURVIVAL 2018
Every dollar represents hope, strength, and a lasting impact!
December 19, 2017
With the holiday season in full swing, it’s hard not to reflect on this past year and realize how thankful Veristat is to play such an instrumental role in the world of clinical research.