ClinTrialStat e-Submission Services are intently focused on assisting eNDA, eBLA, and ePLA filing preparation efforts by providing an industrial strength validation support process for all CSR, ISS and ISE table along with figure programs and source datasets.

Anyone who has had experience in the electronic regulatory submission process knows the paramount value of a well-coordinated project team. Each specialty group has specific contributions to make, and if they can manage to deliver fully compliant materials in accordance with the project plan, chances of meeting key project milestones and meeting the submission delivery date are substantially improved.

But by nature the clinical development process is characterized by aggressive timelines and even talented professionals facing tight deadlines can often be prone to oversight and error. The only rational approach to managing this process risk is to submit all contributed submission materials and content to a systematic and fully-documented QA/QC review process. Only then can you have unwavering confidence that the evidence and findings you are submitting to support your labeling claims will stand the rigorous scrutiny of a regulatory review.

ClinTrialStat e-Submission Service functions as an extension of your submission project team. We work closely with your project management, eCTD, statistical analysis and clinical data specialists as we streamline the clinical study report and integrated analysis production groups to perform an independent qualification of the respective work products. By doing so, we can execute a detailed verification of the individual table and figure content and setup the individual SAS and WinNonlin programs to operate within the eCTD file structure according to Food and Drug Administration guidelines.

Utilizing an array of qualification methods, including parallel programming, data transformation algorithm verification, frequency counts, and bench checks, we can simulate a Food and Drug Administration execution of each of these programs within the e-submission environment and certify error-free performance and output accuracy. Discrepancies are resolved in close interaction with the analysis stakeholders. All content promoted to CTD integration undergoes 100% qualification verification.