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Clinical Programming

CDISC Logo SAS Ceritfication Badge

Pentara recognizes the benefits of having high standards for our industry. Pentara requires all programmers to be SAS certified. Even our summer interns must be SAS certified before they can work here.

SDTM

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CDISC is the standard for submitting clinical data to regulatory agencies. As a Gold member of the CDISC organization , Pentara maintains up-to-date knowledge on SDTM implementation guidelines. Our SDTM services include developing SDTM datasets and documentation for ongoing studies or 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

Regulatory submissions demand thorough studies. Pentara clinical programming offers a complete review of existing SDTM packages, ensuring they meet all regulatory requirements and expectations. Our expertise addresses data gaps and inconsistencies, optimizing your datasets for efficient and clear review. This proactive approach prevents delays by aligning with global regulatory standards like those from the FDA, EMA, and PMDA.

Beyond compliance, Pentara enhances the quality and interpretability of your data. We perform rigorous validation and ensure accurate, complete metadata, building a strong, meticulously prepared submission package for a smoother regulatory review.

Collaborating at Desk.

Data Cleaning

Working on Whiteboard

Pentara Clinical Programming optimizes data cleaning via comprehensive support. We use SAS edit checks to quickly find and fix data issues and conduct vendor reconciliation to ensure consistency. Our team creates custom reports for clear insights and oversees data management (DM) activities to ensure smooth CDISC standards implementation.

Pentara Clinical Programming provides programming support to ensure efficient and complete data cleaning. Services include:

  • SAS edit checks
  • Vendor reconciliation
  • Custom reporting
  • Oversight on DM activities and documents to ensure smooth implementation of CDISC standards

Frequently Asked Questions

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.
These are edit checks that are not feasible to program into an EDC system but are important for data cleaning, such as complex comparisons across forms and free-text review. A custom SAS edit check can perform these complex derivations to produce a report that a data manager can use to post the appropriate queries and track responses.
As soon as possible! Our end goal is to provide CDISC-compliant SDTM datasets and documentation that are submittable to regulatory agencies. The best way to ensure the quality of the data in these SDTMs is to include Pentara clinical programming as early as possible during the Protocol development. We can provide expertise on the study design that ensures the collected data will have a seamless transition into SDTM datasets and analysis. During study build, Pentara Clinical Programming can have its eyes on the EDC, edit checks, DTAs, etc., to ensure that standards are applied at the beginning. During study conduct, Pentara Clinical Programming can keep an eye on the data to ensure routine data cleaning is preventing a list of data errors to explain in a submission later.
If you ever plan to submit to a regulatory agency, then SDTMs should be created for every study. The FDA requires SDTM datasets. We have found that it usually ends up costing less to plan for SDTM up front. In the end, the upfront investment in SDTM programming will prevent unexpected future costs and challenges. Additionally, SDTM programming will highlight a variety of data quality issues that you will want fixed before you lock your database. The way in which SDTM programming translates raw data into a standard format brings out issues that are not generally caught in routine data management. It is important to catch these issues as soon as possible so they can be resolved at the source.
Pentara is known for efficiency. We have a strong team of programmers that focuses on providing a quality result in the most robust way possible. We don't do anything just because it's the way it's always been done. We ensure that each project is given specific attention to ensure that all nuances are handled appropriately. We have a strong attention to detail with the mindset that all issues should be resolved at the source rather than handled after the fact. We ensure all standards are applied from the very beginning to ensure a seamless transition from data collection to submission. Our goal is to provide the highest quality SDTM package possible. To us, that does not just mean that we produced the best possible SDTM package given the data we received. Instead, we ensure that our influence extends to data collection such that the data we receive is the highest quality possible and the SDTM package follows suit.
Yes! Our team has contributed to multiple submissions to regulatory agencies and can provide a thorough review of your SDTMs to ensure they meet all requirements. We will often review SDTMs from another CRO in advance of an FDA submission. We have yet to receive SDTMs for which we did not have any feedback for improvement!