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. Food and Drug Administration (FDA). This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials.

Compliance 86

Compliance Clinical Trials Clinical Trials Trials 86

Cloudbyz

JUNE 2, 2023

Electronic Data Capture (EDC) has revolutionized clinical research and pharmaceutical drug development. However, adopting this system requires a significant financial commitment. Initial Costs The initial costs of implementing an EDC system can be substantial, encompassing both direct and indirect expenses.

Clinical Trials 68

Clinical Trials Clinical Trials Laboratory Information Management System Compliance 68

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