Clinical system implementation and configuration for EDC, IRT, eTMF, and QMS systems in compliance with 21 CFR Part 11 regulations, including:
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• 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