Data Integrity Resources, LLC Information

Data Integrity Resources provides services to pharmaceutical and biotechnology companies as well as other consulting firms on effective clinical system implementation, clinical data management, and system validation techniques. Our Services Include: Clinical system implementation and configuration for EDC, IRT, eTMF, and QMS systems in compliance with 21 CFR Part 11 regulations, including: Validation Master Plan creation IQ/OQ/PQ Protocol creation IQ/OQ/PQ Test Script creation, review, and execution Validation Summary Report Clinical Data Standardization, Data Migrations, and Data Management Plans Clinical Drug Supply Management Clinical system process development and implementation Standard Operating Procedure development, implementation, and review System vendor selection and qualification Provide guidance to clients on issues related to clinical system maintenance, quality control and quality assurance, including system compliance audits, clinical data management audits, and full vendor audits (full vendor audits are performed in combination with a partnering consultant) Clinical database design and implementation Clinical data integrity check design, programming, and validation Medical Coding System implementation and review External data reconciliation process development, implementation, and execution Query generation and tracking system development and implementation Clinical Data Management quality control and quality assurance techniques including Database Quality Control Plans. Clinical Data Mapping Documents for CDISC/CDASH Standards Case Report Form design and review Clinical Data Management mentorship and leadership skills training