Master CDISC standards (SDTM, ADaM), electronic data capture (EDC) systems, trial management workflows, and 21 CFR Part 11 compliance to enable efficient multi-site clinical research.
Clinical trial software encompasses the digital infrastructure to run multi-site, regulated clinical studies: electronic case report forms (eCRF), randomization systems, adverse event tracking, and statistical analysis platforms. Most work orbits CDISC standards (SDTM, ADaM) mandated by FDA for regulatory submission. Core responsibilities:
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