Accuracy matters. In fact, a minor inaccuracy during the FDA approval process can end up costing your organization an average of a million dollars a day for an average of three months. And if your CRO doesn’t provide you with an accurate estimate, you can start adding significant costs on top of that. Read more
Of course, this is a false dichotomy. You need both from your biostatistical contract research organization (CRO). Inaccurate research and data analysis isn’t just useless, it’s very costly — to the tune of one million dollars a day. That doesn’t even include the cost to your organization’s reputation or a potential exodus of investment dollars. Read more
When it comes to selecting a biostatistical CRO, most sponsors choose to work with the cheapest proposal. But that’s a mistake and your organization will pay dearly for it in the long run. Not only does the lowest bid frequently come with a number of hidden costs and overages, there’s also the small matter of accuracy — and compliance. Accuracy, in the final analysis, should be the ultimate factor when deciding which CRO will conduct your biostatistical research. To use any other criteria is to gamble with your organization’s future. Read more
Per PDUFA V Commitment, FDA shall issue final guidance on the standards and format of electronic submission of drug marketing application by end of 2014. All new original NDA and BLA submissions, supplements and amendments are required to follow the final guidance by end of 2016. All original commercial INDs and amendments are required to follow the guidance.