Chemon Inc. is a privately owned, non-clinical contract research organization (CRO) headquartered in Suwon, South Korea with a certified research laboratory in Yongin.
Julie Jones, a company representative at the UK-based IT solutions company, Instem, told us Chemon is currently collecting their preclinical study data using a combination of manual processes (i.e. collecting data on paper) and Excel.
“This is very labor intensive as the data then needs to be transcribed from the paper forms into Excel and it is also more prone to transcription errors,” she said.
To automate this process at its laboratory in Yongin, ChemOn purchased Instem’s Provantis preclinical data management solution as well as its submit software suite for creating and managing SEND-compliant datasets.
“Chemon will no longer need to manually create study reports and will be able to provide study reports to the regulators and their clients in a more timely manner,” said Jones.
SEND (Standard for Exchange of Nonclinical Data) is an implementation of the CDISC Standard Data Tabulation Model (SDTM), which specifies a way to present nonclinical data in a consistent file format, as well as variables and standardized scientific terminology.
As Jones noted, the SEND initiative is having “a big impact” on the pharma R&D community.
The mandate, which requires all datasets from studies supporting new drug applications, biologics license applications, and abbreviated new drug applications to be submitted in SEND format, went into effect December 2016.