SDTM And ADAM Training
By CDISC (Clinical Data Interchange Standards Consortium) criteria, participants in SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) training are taught how to standardize and manage clinical trial data. Data format, organization, and submission to regulatory bodies such as the FDA and EMA are all covered in the program. Whereas ADaM is intended to develop datasets for statistical analysis, SDTM concentrates on gathering and arranging clinical trial data.
- 10+ Courses
- 30+ Projects
- 400 Hours
Target Audience
SDTM And ADAM Training is suitable for the following target audiences:
Clinical Data Managers: Experts in managing clinical trial data and guaranteeing adherence to industry norms.
Biostatisticians: Those who examine data from clinical trials and use ADaM files for reporting and statistical modeling.
Regulatory Affairs Specialists: Regulative affairs specialists are professionals in regulatory submission positions who ensure that clinical data is formatted correctly for submission to health authorities.
SAS Programmers: IT specialists focusing on clinical trial coding and programming who must create datasets in SDTM and ADaM formats.
Professionals in the pharmaceutical and biotechnology industries: Those involved in clinical trials and medication development must comprehend data management procedures and legal standards.
Job Opportunities in the USA and Canada
Clinical Data Manager: Supervising the gathering and administration of clinical trial data in compliance with SDTM guidelines.
SAS Programmer: Writing programs to transform unprocessed clinical data into SDTM and ADaM forms for analysis and submission to regulatory bodies is known as SAS programming.
Biostatistician: Conducting statistical analysis and interpreting clinical trial results using ADaM databases.
Regulatory Submission Specialist: Prepare clinical trial data and send it to regulatory agencies, including Health Canada and the FDA, using SDTM format.
Clinical Research Associate (CRA): A clinical research associate (CRA) ensures that clinical data gathered during trials complies with CDISC standards, such as SDTM.
Professionals with expertise in SDTM and ADaM are in great demand in the USA and Canada, especially in the biotech, pharmaceutical, and CRO (Contract Research Organization) industries, where data standardization and regulatory compliance are essential to the success of clinical trials.
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