What Is A Data-Focused CRO, And What Are Its Benefits?
The International Conference on Harmonization Good Clinical Practice (ICH-GCP) defines the Sponsor of a clinical trial as an individual, company,
Bioforum Blog
Risk Based Approach in Data Management
Data quality within the clinical research enterprise can be defined as the absence of errors that matter and assurance that
Regulatory Landscape
Clinical study data is defined by the FDA as information about a person in a clinical trial, that may include
At A Glance – What’s New In The FDA Technical Conformance Guide Version 3.3
The FDA has recently published a new version of the Technical Conformance Guide (TCG) with updates that impact regulatory data submissions. Technical
Study Data Standardization Plan – Importance And Advantages
The SDSP (Study Data Standardization Plan) is a document intended to communicate to CDER (Center for Drug Evaluation and Research) and
SEND – Overview In Light Of FDA Requirements
SEND (Standard for Exchange of Nonclinical Data) is a means of implementing CDISC Standard Data Tabulation Model (SDTM) to represent nonclinical data. SEND
