Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Let’s explore.

Clinical Trials 98

Clinical Trials Clinical Trials Compliance Trials 98

Cloudbyz

AUGUST 26, 2024

The clinical research industry is in the midst of a digital revolution, with Clinical Trial Management Software (CTMS) at the forefront of this transformation. The Early Days: Legacy CTMS Systems In the early days of clinical research, managing trials was a manual, paper-based process.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Laboratory Information Management System 52

XTalks

DECEMBER 5, 2023

Central labs ensure consistency in test methodologies, equipment and reporting standards, which is vital for the integrity of clinical trials. Accurate and reliable lab data play a crucial role in any clinical trial. The processes do not simply involve receiving a sample, testing it and producing a result, he says.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Laboratory Information Management System 105

Cloudbyz

MAY 15, 2024

Study Execution and Monitoring: Our system facilitates real-time tracking of study progress, monitoring of clinical trial sites, and management of investigator performance. The guidance notes, “Information from pharmaceutical development studies can be a basis for quality risk management” (p.

Compliance 52

Compliance Laboratory Information Management System Clinical Trials Clinical Trials 52