CAMBRIDGE, Mass.--(BUSINESS WIRE)--PROMETRIKA, a full service clinical research organization, has announced the successful implementation of the Medidata Coder product and integration with the Medidata Rave electronic data capture (EDC) system. Accredited in the Rave Coder Platform in March 2017, PROMETRIKA is now capitalizing on the synergy between the two systems, to the benefit of study sponsors.
Medidata Coder is an application that maps verbatim terms such as “adverse events” or “concomitant medications” to specific codes in industry-standard dictionaries like MedDRA and WhoDrug. Integration with Medidata Rave allows terms entered into the database to be processed through Medidata Coder and automatically placed in the Rave database.
“Implementing Medidata Coder is an example of how we are always looking for ways to better serve study sponsors, both in terms of productivity and data quality,” said Miganush Stepanians, Ph.D., President and CEO of PROMETRIKA. “While we’ve been using Medidata Coder, we have seen a number of benefits from its ability to accurately assign codes to verbatim terms in real time.”
Among the advantages PROMETRIKA and its clients are enjoying from the new integration are:
- Customizable Configurations: The ability to configure the system to meet study-specific workflows and approval processes
- Review Process Enhancements: Capabilities like manual coding or real-time auto-coding, the creation of synonyms and synonym lists, direct querying of study sites to clarify verbatim terms, reclassification of terms, code consistency review, and generation of coding consistency listings that make information available for Safety Review and Data Monitoring Committee meetings
- Quality Control Measures: Coding consistency review that can be performed continuously, allowing for faster feedback on coding assignments and serving as an extra level of quality control in addition to that provided by the Clinical Data Manager (CDM)
About PROMETRIKA, LLC - www.prometrika.com
Founded in 2003 and based in Cambridge, Massachusetts, PROMETRIKA is a unique full-service Clinical Research Organization (CRO) in its industry, utilizing a caring and collaborative approach to clinical development and execution with a close-knit, highly-tenured senior leadership team involved in all phases of trials. PROMETRIKA’s services include clinical operations, data management, biostatistics, medical writing, pharmacovigilance and regulatory submissions.