2020 has proven to be an incredibly pivotal time for the life sciences industry. While COVID-19 has created limitations around
Published in Medical Writing Magazine, Volume 29 Number 2 | June 2020 Authors: Shiri Diskin, Tanya du Plessis, Ofra Barnett-Griness
No clinical trial sponsor intentionally plans a study migration. Sometimes the decision to migrate data from one database (or data
Alongside data managers, statistical programmers and medical writers, biostatisticians play an integral role in the collaborative effort to develop new
400 attendees, 25 speakers, 7 countries represented and a bright future ahead for clinical research! Celebrating Bioforum’s 20th anniversary in
In October 2017 Bioforum has officially set up its office in Melbourne headed by Nadia Nahmany, VP of Australian Operations.
The International Conference on Harmonization Good Clinical Practice (ICH-GCP) defines the Sponsor of a clinical trial as an individual, company,
The FDA has recently published a new version of the Technical Conformance Guide (TCG) with updates that impact regulatory data submissions. Technical
The SDSP (Study Data Standardization Plan) is a document intended to communicate to CDER (Center for Drug Evaluation and Research) and
SEND (Standard for Exchange of Nonclinical Data) is a means of implementing CDISC Standard Data Tabulation Model (SDTM) to represent nonclinical data. SEND
