CDISC | Data Mapping Service
Submission-ready clinical trial data for swifter approval
We advise you on how to collect and structure clinical trial data and help map your data in accordance with the CDISC data standards to ensure a swift approval process for your medical drug of device.
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Avoid a lengthy approval process
Submitting non-compliant or semi-compliant clinical trial data is a red flag to the regulatory agencies and will often draw out the approval process.
If medical authorities such as the FDA have trouble deciphering the trial data, you are likely to find yourself having to answer several extra questions and resubmit parts of or all your data.
This is an unnecessary and potentially costly delay in the time to market of your medical drug or device.
Poor data quality can also harm your ability to attract investors as it obscures the conclusions of your study.
Get fully CDISC compliant, submission-ready data
At BioStata, we prepare your clinical trial data for submission in accordance with the CDISC standards, whether you wish to submit data from an older study, an ongoing study or are in the process of setting up a new clinical trial.
We offer a full CDISC service, from advising you on how best to collect your clinical trial data to mapping your data in accordance with SDTM and AdaM and readying your data for submission.
You get a data set that is fully compliant with CDISC standards and ready for submission to the FDA or other relevant agencies.
Data mapping for clinical trials of medical devices
Following CDISC standards is not a requirement when applying for approval of medical devices. However, in our experience the approval process is much quicker and results in fewer questions when adhering to the CDISC format.
Learn how we can help map your clinical trial data:
Who we help
Our CDISC services are designed for smaller biopharma enterprises with no or only limited biometrics resources in-house.
You get:
- Guaranteed CDISC compliance
- FDA submission-ready data
- Reduced risk of time-consuming follow-up questions
- A swifter approval process
- Reduced time to market.
3 reasons why Biostata is a sensible choice of CDISC partner
1. You get experienced data specialists
We specialize in biometrics and handpick only the most experienced data specialists for our team. Most of us have worked in biometrics for up to 20+ years and know the CDISC format inside out.
2. We work on trust
We believe that the best foundation for a stable, long-term business relationship is mutual trust, and we work hard to earn yours. We often initiate the collaboration by mapping a limited data set and expand from there.
3. We adjust to your needs
Our flexible, tightly knit team can easily adjust the process and scope of the CDISC project to match your needs and budget.
A typical CDISC data mapping process
FAQ
CDISC is an abbreviation of the Clinical Data Interchange Standards Consortium. It is a set of global data standards for the pharmaceutical industry, developed to make the interchange of clinical research data between sponsors and regulatory agencies simpler and more transparent.
SDTM (short for Study Data Tabulation Model) is a CDISC standard. CDISC SDTM is a framework for organizing clinical research data in a database. The SDTM standard describes the structure, content, and attributes of the clinical data set in a common format that is easy for regulatory reviewers to decipher.
In other words, CDISC SDTM is developed to speed up the data reviewing process and get your drug or medical device on the market quicker.
SDTM and ADaM are both CDISC standards. SDTM (Study Data Tabulation Model) describes the structure of the data set while ADaM (Analysis Data Model) defines how the data should be analysed.
SDTM is a requirement when submitting clinical research data to the FDA. ADaM is not formally required (yet), but we recommend adhering to the standard as it speeds up the review process.
The time spent on data mapping depends on the scope of each project. Mapping the data of an ordinary study with no major obstacles takes roughly 600-700 hours.
Following the CDISC data standards is a requirement from regulatory agencies such as the FDA in the US and PNMA in Japan when applying for approval of medical drugs.
It is not a requirement for approval of medical devices, but we recommend complying with the standard to speed up the approval process.
If you have data from older studies that were not collected according to CDISC standards, we can often help clean up the data and adapt them to the CDISC data formats.
Sometimes this is not possible, however. Instead, we can explain why the data are not CDISC compatible in a way that satisfies the regulatory agencies and anticipates any follow-up questions.
If you have any further questions about our CDISC data mapping services, we are happy to help: