CLINICAL TRIALS DIVISION
eClinical Standards

Anju Professional Services has extensive experience helping customers define and deploy clinical data standards.

ECLINICAL STANDARDS

CDASH – Anju was the first to implement a library of CDISC-CDASH eCRF forms in October 2008.

SDTM – Anju was the first to deploy an SDTM mapping utility that maps EDC forms into CDISC-SDTM compliant datasets, enabling clients to generate and download current SDTM datasets on demand immediately following initial SDTM implementation.

SMART (Substitutable Medical Apps, Reusable Technology) on FHIR (Fast Healthcare Interoperability Resources) – Anju is pioneering one of the first portable user interfaces (SMART app) to leverage the HL7- and CDISC-accepted FHIR web service APIs to extract data from any SMART on FHIR supported EHR to the TrialMaster EDC in a secure, standard format.

Company standards – Anju has worked with companies to develop corporate clinical data standards based on industry standards and therapeutic area-specific requirements or best practices.

E2B – Using our SafetyLink™ solution, Anju can transfer serious adverse event data between our EDC technology and your company’s global pharmacovigilance solution, leveraging the ICH E2B standard.

MedDRA and WHODrug – Using our proprietary AutoEncoder technology, Anju can deliver solutions to code against MedDRA, WHODrug, and other standard industry vocabularies.

caBIG – Anju professionals have made a commitment to provide leadership, support and continuing contributions to the caBIG™ cancer research initiative, including development of a caDSR (cancer Data Standards Repository) metadata library, a library of forms to support the Clinical Trials Monitoring Service semantics and nomenclature, plus support for the CTCAE, CTEP simplified disease classification.

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