Jan 17, 2022
Ensuring Clinical Trial Data Integrity: Five Things to Remember When Selecting a CRO Partner ...
Nov 17, 2021
PolyPid Ltd. is a Phase 3 biopharma company aiming to improve surgical outcomes through locally...
Jul 08, 2020
Published in Medical Writing Magazine, Volume 29 Number 2 | June 2020 Authors: Shiri Diskin,...
Apr 07, 2020
No clinical trial sponsor intentionally plans a study migration. Sometimes the decision to migrate data...
Feb 03, 2020
Alongside data managers, statistical programmers and medical writers, biostatisticians play an integral role in the...
Dec 22, 2019
Regulatory submissions are the most critical milestones in clinical research programs. Quality submissions can accelerate...
Oct 24, 2018
The International Conference on Harmonization Good Clinical Practice (ICH-GCP) defines the Sponsor of a clinical...
Oct 24, 2018
The FDA has recently published a new version of the Technical Conformance Guide (TCG) with updates that...
Oct 24, 2018
The SDSP (Study Data Standardization Plan) is a document intended to communicate to CDER (Center for...
Oct 24, 2018
SEND (Standard for Exchange of Nonclinical Data) is a means of implementing CDISC Standard Data Tabulation Model (SDTM)...