Everything can be going wrong, but late stage analysis can save the day for your new treatment. Previously, we discussed how the Phase Three clinical trials and approvals process is significantly more difficult than the first two combined. Late stage analysis can save the day for many organizations.
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2018-09-06 14:52:272025-04-07 17:45:10How Late Stage Analysis Can Save the Day
There’s no two ways about it: Submitting your work is significantly more difficult than earlier stages of clinical trials. That’s because you have to integrate all of your previous analysis into a single, cohesive whole. Those studies might stretch back as far as a decade. What makes the process even more challenging is that these […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2018-08-13 11:00:432025-04-07 17:21:47Submissions Are Significantly More Difficult Than Clinical Trials
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.
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2018-05-30 20:01:082025-04-07 17:40:07Why Estimation Accuracy Matters For The FDA Approval Process
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.
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2018-05-01 11:28:152025-04-07 17:05:01Speed Or Accuracy? You Need Both.
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 […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2018-05-01 11:20:012025-04-07 17:40:36Regulatory Compliance Has No Tolerance for Error
How Late Stage Analysis Can Save the Day
in Approval Glitches / ProblemsEverything can be going wrong, but late stage analysis can save the day for your new treatment. Previously, we discussed how the Phase Three clinical trials and approvals process is significantly more difficult than the first two combined. Late stage analysis can save the day for many organizations.
Submissions Are Significantly More Difficult Than Clinical Trials
in Getting FDA ApprovalThere’s no two ways about it: Submitting your work is significantly more difficult than earlier stages of clinical trials. That’s because you have to integrate all of your previous analysis into a single, cohesive whole. Those studies might stretch back as far as a decade. What makes the process even more challenging is that these […]
Why Estimation Accuracy Matters For The FDA Approval Process
in Choosing a CROAccuracy 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.
Speed Or Accuracy? You Need Both.
in Choosing a CRO, Getting FDA ApprovalOf 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.
Regulatory Compliance Has No Tolerance for Error
in Approval Glitches / ProblemsWhen 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 […]