Data management and biostatistics are the functions that determine whether the data generated by your study can withstand regulatory scrutiny. A database that has been cleaned inconsistently, a statistical analysis plan that was not followed, a dataset that does not map cleanly to CDISC SDTM or ADaM standards – these are not minor technical issues. They are the types of problems that generate regulatory questions, delay submissions, and in some cases require additional studies.
For sponsors in Phase II or Phase III development, data management and biostatistics are not back-office support functions. They are the functions that produce the submission package. Their quality determines the speed and outcome of regulatory review.
At APICES, data management and biostatistics are fully in-house. The biostatistician who designs the statistical analysis plan is the same person who supervises analysis execution and defends the outputs in the clinical study report. There are no handoffs between internal and external teams, and no situations where delivery context exists in one team and technical expertise exists in another.
APICES provides data management for Phase I through Phase III interventional studies, including first-in-human studies, proof-of-concept trials, pivotal efficacy studies, and post-approval studies. EDC platforms supported include Veeva Vault CDMS, Medidata Rave, Castor EDC, OpenClinica, and REDCap.
Database design, edit check programming, and external data integration (ePRO, laboratory, imaging, wearable data) are performed to ICH E6(R3) standards, with full audit trail documentation. Data review is continuous throughout the study, not limited to a pre-database lock review cycle.
SDTM conversion, ADaM dataset derivation, define.xml preparation, and the Reviewer's Guide are standard outputs of the APICES data management process for regulatory submissions. These have been delivered to EMA, FDA, MHRA, and PMDA.
Statistical analysis at APICES is led by a senior biostatistician who is assigned to the study at the analysis planning stage and stays engaged through CSR sign-off. Study timelines do not involve reassigning statistical work to a junior analyst at the execution stage.
Regulatory submissions to EMA and FDA increasingly require CDISC-compliant SDTM and ADaM datasets as a condition of submission acceptance. APICES prepares these datasets as a standard deliverable, not as an optional add-on. The define.xml and Reviewer's Guide required for FDA eSubmission are produced alongside the datasets, ensuring that the submission package is complete at database lock.
An incomplete CDISC package at the point of NDA or MAA filing extends the review timeline and may result in a Refuse to File or Validation Letter. Having the CDISC package prepared by the same team that designed and executed the study eliminates the most common source of submission-time inconsistencies.
Which EDC systems does APICES support?
Veeva Vault CDMS, Medidata Rave, Castor EDC, OpenClinica, and REDCap. We can build a study from scratch or take over an existing build.
Can you do interim analyses and adaptive design support?
Yes. We provide DSMB/DMC support, interim analysis statistical plans, and adaptive design SAPs for oncology and rare-disease trials.
How do you handle SDTM, ADaM, and define.xml for regulatory submission?
Standard SDTM and ADaM datasets, define.xml, and Reviewer's Guide are part of our regulatory-grade output. We have submitted to FDA, EMA, MHRA, and PMDA.
Do you handle real-world-data analytics?
Yes. We support claims, EHR, and registry-based analyses with appropriate statistical methods (propensity score, ITC, target trial emulation) under ENCePP and ISPE guidance.
Who is the lead biostatistician on a study?
A senior biostatistician owns the SAP and stays engaged through to CSR sign-off – they are not a name on a bid replaced by a junior in delivery.
If you are preparing your next early clinical study or want to sanity-check how your program is set up, the next step is a focused conversation.
No packaged answers. Just context, experience, and a clear view on fit.
