Can You Afford Risking a Delayed Regulatory Submission?
Before the FDA start reviewing a submission, your submission must first overcome the new hurdle of ensuring that it conforms to the standards required in the FDA Data Standards Catalog.
In a recent analysis conducted by the FDA, 32% of submissions with study data had critical data conformance issues. When a submission is rejected for lack of study data conformance, the submission sequence is not even transferred from the FDA Electronic Submission Gateway into the FDA electronic document rooms where the FDA Review process officially starts!
Then only 50% of new NME/IND applications that passed the screening process for study data conformance are approved on first submissions by the FDA. There is a median delay of 435 days to approval following the first unsuccessful submission and 24% of the first-time submission failures include inconsistent study results either across endpoints or sites and studies.
Re-submission of failed applications is costly, delaying marketing approval as the process needs to start again with increased timelines, and delaying the availability of vital new drugs to patients.
The efficacy associated reasons for failed first-time submissions are:
Poor efficacy when compared with the standard of care
Uncertainties related to dose selection
Choice of study endpoints that fail to adequately reflect a clinically meaningful effect
Inconsistent results with different end points selected
Study conduct due to missing data and/or data integrity issues
Choice of study endpoints that fail to adequately reflect a clinically meaningful effect
How to reduce the risk of a delay?
We review your submission content to:
- Ensure that data are formatted and submitted according to the correct data standards
- Uncover atypical data patterns within or across studies that act as a red flag warning to investigate further for an FDA Reviewer
- Investigate the influence of atypical data patterns on the robustness of the submission efficacy and safety conclusions
Study Data Conformance
Quanticate offers CDISC Compliance services and CDISC mapping expertise across multiple situations. When reviewing submission data our team will ensure that CDISC standards are met before the submission is sent with support on:
SDTM Compliant Datasets and supporting documentation (define.xml, cSDRG, aCRF)
Data Quality Oversight
Quanticate provide a Data Quality Oversight (DQO) service to examine the quality and fitness of the data package associated with the submission. Quanticate has selected the industry leading FDA endorsed software of CluePoints to perform its DQO analysis. We use CluePoints’ machine learning functionality to detect spurious data patterns both within and across studies. If appropriate, we also use software such as SAS JMP for further statistical investigation. DQO enables the quick identification of outliers and inconsistencies across studies which can then be addressed to improve data quality.
![[Webinar] Regulatory Submission Review](https://www.quanticate.com/hs-fs/hubfs/Resources-2022/webinars/%5BWebinar%5D%20Regulatory%20Submission%20Review.jpg?width=250&name=%5BWebinar%5D%20Regulatory%20Submission%20Review.jpg)
.jpg?width=250&name=Integrated%20Summaries%20(ISS%20ISE).jpg)
