article thumbnail

Learn how the Cloudbyz Vet eClinical Platform aligns with the latest FDA guidelines

Cloudbyz

The FDA Center for Veterinary Medicine (CVM)’s draft guidance on pharmaceutical development for veterinary medicines outlines a systematic approach to ensure the quality, safety, and efficacy of veterinary drugs. Effective risk management and control strategies ensure the safety and efficacy of the veterinary drug.

article thumbnail

Unpacking the Financial Implications of EDC System Implementation: Initial Costs, Long-term Savings, and ROI

Cloudbyz

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Mastering 21 CFR Part 11 Compliance: A Comprehensive Guide for Clinical Trials in the Digital Age

Cloudbyz

Food and Drug Administration (FDA). Understand the Scope: First and foremost, understand the electronic systems you use and determine which records are subject to 21 CFR Part 11. Develop SOPs: Create Standard Operating Procedures (SOPs) outlining the correct use of electronic systems.

article thumbnail

How Can a Central Lab Deliver Essential Lab Data and Optimize Study Timelines?

XTalks

In today’s digital age, the enormous amount of data generated in clinical studies necessitates the need for powerful, dynamic digital tools that provide data integration in real time from which insights can be garnered to help inform clinical decisions. It has kind of been a black box until you develop tools that allow for that.”

article thumbnail

You think you need an ELN… but are you asking the right questions?

Drug Discovery World

There’s even a name for the downsides of such under-supported products, poor integrations, and bad user experience: frustrated ELN users call this the “tax on science” That tax has a real cost in terms of drug discovery. This transition improved intellectual property management for early drug discovery.