#0 (0%) - definer3.com
Title: Define R3 - A Tool to generate Define XML accurately for Regulatory Submission
Description: We facilitate creation of Study -SDTM/ADaM/SEND, Process and Generate Study Metadata, Generate Define XML, manage all your documents such as - CRF, SDTM & ADaM datasets etc. We will generate your define.xml package for submission and with a pdf version (
Keywords:Define XML Generator, Define XML Generation Tool, Define-XML, Define R3, Define-r3, Define.xml, Clinical Trial data, Clinical Trial data submission, CDISC, Study Metadata, CDISC Metadata, Control Terminologies, Annotated CRF, SDTM, ADaM, SEND, WhereClause, Codelist, External Codelist, Computation Methods, Symbiance, clinical data analysis, clinical data management, clinical regulatory submission, Subject Elements,
... (View More)
Subject Visits, Trial Arms, Trial Elements, Trial InclusionExclusion Criteria, Trial Summary, Trial Visits, Comments, Demographics, Adverse Events, Concomitant Medications, Disposition, Protocol Deviations, Exposure, Medical History, Substance Use, Clinical Events, Drug Accountability, ECG Test Results, Findings About Events or Interventions, InclusionExclusion Exceptions, Inclusion Exclusion Criteria Not Met, Laboratory Test Results, Microbiology Specimen, Microbiology Susceptibility Test, Pharmacokinetic Concentrations(View Less)