Please contact us at info@sofpromed.com if you need SDTM services for your clinical trial
Clinical trials play a crucial role in the development and evaluation of new therapies.
However, effectively managing the data generated during these trials, and having the datasets ready for submission to the Food and Drug Administration (FDA), can be a complex and time-consuming task.
This is where SDTM programming services come into play.
In this article you will learn about:
SDTM, or Study Data Tabulation Model, is a standard developed by the Clinical Data Interchange Standards Consortium (CDISC) to organize and structure clinical trial data to be sent to regulatory authorities.
In this article, we will explore the importance of the SDTM standard, the benefits of SDTM programming services, and how they can streamline and improve the quality of the data management process for clinical trials.
Understanding the Importance of the SDTM Standard
CDISC standards, including SDTM, have gained significant recognition and adoption by regulatory authorities worldwide.
In the United States, the FDA requires the submission of datasets using CDISC standards for various applications, including Commercial Investigational New Drug (IND) applications.
These standards ensure that clinical trial data is collected, analyzed, and submitted in a normalized, well-structured manner.
SDTM, as a part of the CDISC standard family, provides a model for organizing and formatting data, streamlining processes in data collection, management, analysis, and reporting.
By implementing SDTM, sponsors can ensure the quality and compliance of their data, improve data consistency across studies, reduce error rates, and facilitate the regulatory review and approval process.
The Benefits of SDTM Programming Services
SDTM programming services offer a range of benefits to clinical trial sponsors, including:
- Efficient Trial Design and High-Quality Data
SDTM programming can assist sponsors in designing their trials from the beginning, ensuring that the data collection process aligns with the SDTM standard.
By implementing SDTM from the outset, sponsors can optimize data collection, improve data integrity, and minimize the need for data conversion at later stages.
This approach leads to more efficient trial design, high-quality data, and ultimately, the success of the study.
- Streamlined Data Submission Process
Submitting datasets in SDTM format is a requirement for regulatory authorities like the FDA.
SDTM programming services can help sponsors prepare datasets in SDTM format, ensuring compliance with regulatory requirements.
By utilizing the expertise of SDTM programming professionals, sponsors can streamline the data submission process and reduce the risk of errors or rejections.
- Faster Approval Time
Implementing the SDTM standard from the beginning of a clinical trial can significantly reduce the time required for data conversion and preparation for submission.
By adopting SDTM, sponsors can expedite the approval process, enabling faster access to valuable insights and accelerating the development and evaluation of new therapies.
- Consistency and Reusability
SDTM programming promotes consistency across studies by utilizing standardized variable names, controlled terminology values, and dataset structures.
This consistency not only facilitates data exchange internally and across vendors but also supports the reuse of datasets and mappings in future studies.
By maintaining standards, sponsors can save time and resources while ensuring data quality and compliance.
Implementing SDTM in Clinical Trials
Implementing SDTM in clinical trials requires expertise in CDISC standards, data management, clinical trials, and statistical programming.
Biometrics CROs specialized in SDTM programming services offer a range of solutions to assist sponsors in implementing SDTM effectively:
- Data Management Planning for SDTM
SDTM programming services include data management planning, where sponsors can collaborate with experts to plan for the implementation of SDTM from the beginning of a trial.
By considering SDTM requirements early on, sponsors can ensure a smooth and efficient data collection process.
- SAS Statistical Programming for SDTM
SDTM experts also offer SAS statistical programming support for SDTM implementation.
Integrating SDTM with all data programming activities eliminates the need for data conversion or mapping at a later stage.
This integration saves time, reduces errors, and ensures the seamless generation of SDTM datasets.
- SDTM Mapping
SDTM mapping is a critical task in SDTM implementation.
SDTM programmers help sponsors map datasets from non-CDISC structures to CDISC SDTM structures.
This process requires extensive knowledge and skills in CDISC standards and datasets.
SDTM mapping ensures data integrity, traceability, and compliance with SDTM standards.
- SDTM Define.xml Files
SDTM programming specialists assist sponsors in creating SDTM Define.xml files, which describe the content and structure of the trial data.
These files facilitate the review process for regulatory authorities, offering quicker and easier access to study data.
SDTM Define.xml files provide transparency and clarity to reviewers, improving the efficiency of the regulatory review process.
- SDTM Annotated CRF
SDTM programming services help sponsors ensure that Case Report Forms (CRFs) are SDTM compliant.
Annotated CRFs link the fields on the form with the variables in the datasets, providing reviewers with a clear understanding of the data flow.
SDTM programmers assist sponsors in creating CRFs that comply with SDTM data tabulations, supporting the submission process.
- Complete CDISC-compliant, Submission-ready Data Package
SDTM experts ensure the creation of complete CDISC-compliant, submission-ready data packages.
SDTM works in agreement with other CDISC standards, such as Controlled Terminology and Define.xml, facilitating the generation of analysis data sets according to the Analysis Data Model (ADaM).
Through SDTM programming, sponsors can meet regulatory requirements and streamline the submission process.
Conclusion
SDTM programming plays a vital role in unlocking the potential of clinical trial data.
By implementing the SDTM standard from the beginning of a trial and utilizing the expertise of biometrics CROs, sponsors can optimize data collection, ensure data quality and compliance, and streamline the data submission process to regulatory agencies.
Embracing SDTM is a strategic step towards ensuring solid submission-ready clinical trial datasets, which is a vital aspect to successfully bring a new drug to the market.
Please contact us at info@sofpromed.com if you need SDTM services for your clinical trial
