What we know as work has experienced a major transformation. This shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.
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:
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?
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.