"Nobody has traced this data end to end, and we have an audit coming."
Clinical Programming
Submission-grade SDTM and ADaM from a fully SAS-certified, CDISC Gold member team. Your programming package arrives in the structure reviewers expect: the first time, not the third.
Submission-ready datasets, not "SDTM-like" ones
CDISC is the standard for submitting clinical data to regulatory agencies. Our SDTM services include developing SDTM datasets and documentation for ongoing studies, and converting legacy databases to SDTM standards.
Submission documents include
- Annotated Case Report Form
- Validated SDTM datasets
- Clinical Study Data Reviewer's Guide
- Define.xml
- Complex algorithms, if applicable
Pre-SDTM review
A complete review of existing SDTM packages against regulatory requirements. We address data gaps and inconsistencies, optimizing datasets for efficient review and aligning with FDA, EMA, and PMDA standards: rigorous validation plus accurate, complete metadata.
Data cleaning
- SAS edit checks
- Vendor reconciliation
- Custom reporting
- Oversight of DM activities and documents for smooth CDISC implementation
Frequently asked questions
Does Pentara produce SDTM-like datasets? +
No. Pentara makes CDISC-compliant SDTMs that are submittable to regulatory agencies. We have found that deviating from the standards requires more time and effort than producing a compliant set of SDTMs from the start.
What are custom SAS edit checks, and why are they used? +
These are edit checks that are not feasible to program into an EDC system but are important for data cleaning: complex comparisons across forms and free-text review. A custom SAS edit check performs these derivations to produce a report a data manager can use to post queries and track responses.
When should clinical programming become involved? +
As soon as possible. The best way to ensure SDTM data quality is to involve us during protocol development, so the collected data transitions seamlessly into SDTM datasets and analysis. During study build we review the EDC, edit checks, and DTAs; during conduct we watch the data so routine cleaning prevents a list of errors to explain in a submission later.
Do I need SDTM datasets? +
If you ever plan to submit to a regulatory agency, yes: the FDA requires SDTM datasets, and planning for SDTM up front usually costs less. SDTM programming also surfaces data quality issues you want fixed before database lock, because translating raw data into a standard format exposes problems routine data management does not catch.
Why choose Pentara over another CRO? +
Pentara is known for efficiency. We don't do things just because that's how they've always been done; each project gets specific attention so nuances are handled appropriately, and issues are resolved at the source rather than after the fact. Our influence extends to data collection, so the data we receive is the highest quality possible and the SDTM package follows suit.
I already have SDTMs. Do I still need support? +
Yes. Our team has contributed to multiple regulatory submissions and can thoroughly review your SDTMs against requirements. We often review SDTMs from another CRO in advance of an FDA submission, and we have yet to receive a package for which we had no feedback for improvement.
Least expensive point to bring us in · First patient in
Standardization and audit-trail design from the first record. Later, you rebuild the trail during an inspection.
Have your SDTMs reviewed before submission
Send us your package. We'll tell you what a reviewer will ask about.