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...
May 19, 2019
In light of regulatory requirements, CDISC SDTM is now the leading standard for representing clinical...
May 06, 2019
Technological advances, providing better and quicker way for collecting increasing amounts of data, pose a...
Feb 20, 2019
Growing amounts of collected clinical data augment the importance of reassessing the methods used for...
Jan 27, 2019
As one stands in the booth hall of any conference on clinical trials, one will...
Dec 02, 2018
The hierarchy of scientific evidence is a concept from the field of evidence-based medicine. Most...
Dec 02, 2018
Current research is very rarely done by a single investigator and thus a scientific paper...
Oct 24, 2018
The International Conference on Harmonization Good Clinical Practice (ICH-GCP) defines the Sponsor of a clinical...
Oct 24, 2018
Data quality within the clinical research enterprise can be defined as the absence of errors...
Oct 24, 2018
Clinical study data is defined by the FDA as information about a person in a...
Oct 24, 2018
The FDA has recently published a new version of the Technical Conformance Guide (TCG) with updates that...