Glossary:
How eRegulatory Systems Support Clinical Trials
Mar 19th, 2025 in
Glossary
As clinical research evolves, so do the tools and technologies that support it. That includes eRegulatory systems (also known as electronic trial master file or eTMF), which offer cloud-based solutions that enhance document management, ensure regulatory compliance, and improve[...]
Why Clinical Trial Budgeting & Project Management Go Hand-In-Hand
Feb 25th, 2025 in
Glossary
Successful clinical trials rely on detailed budgeting and strong project management for financial sustainability, regulatory compliance, and operational efficiency. Sponsors and research sites must account for fixed and variable costs while maintaining flexibility to adapt to[...]
Clinical Trial Performance Metrics: A Strategic Approach to Success
Feb 18th, 2025 in
Glossary
A clinical trial’s success hinges on more than recruitment numbers and meeting deadlines—it’s about understanding and optimizing every part of the process. Clinical trial performance metrics offer the insight needed to achieve these goals. By tracking and analyzing key[...]
Patient Retention in Clinical Trials: Overcoming Challenges To Drive Success
Feb 4th, 2025 in
Glossary
Patient retention is vital to the success of clinical trials, yet it doesn’t always receive the same level of attention as patient enrollment. For sponsors and contract research organizations (CROs) to meet their trial goals and stay on schedule, they need to hold onto the[...]
Best Practices to Meet 21 CFR Part 11 Audit Trail Requirements
Jan 21st, 2025 in
Glossary
Compliance with 21 CFR Part 11 requires maintaining secure, computer-generated audit trails that document all modifications to electronic records. These trails supportdata integrity by recording what changes were made, who made them, and when. Proper security measures,[...]
Phases of Vaccine Trials: A Comprehensive Breakdown
Dec 17th, 2024 in
Glossary
Vaccine development is a detailed process, broken into clearly defined phases. Each phase addresses specific questions about the safety, efficacy, and scalability of new vaccines, with the ultimate goal of protecting public health. Preclinical Vaccine Research Objectives: [...]
The Impact of IRT Data Integration on Clinical Trials
Dec 3rd, 2024 in
Glossary
Interactive response technology (IRT) systems have changed the way clinical trials are managed. By automating key processes like patient randomization, drug supply management, and data collection, IRT streamlines operations and ensures precision. The integration of IRT systems[...]
Clinical Trial Compliance: Maintaining Ethical Standards and Participant Safety
Nov 26th, 2024 in
Glossary
Compliance in clinical trials is fundamental to protecting the rights of research participants, preserving data integrity, and advancing medical knowledge. To achieve this, trials must adhere to regulatory requirements as well as trial-specific protocols that outline precise[...]
Clinical Trial Project Management: From Recruitment to Regulatory Compliance
Oct 29th, 2024 in
Glossary
Effective clinical trial project management supports smooth trial operations by coordinating regulatory compliance, data management, and stakeholder engagement. It's a matter of managing timelines, controlling budgets, and overseeing recruitment strategies to maintain trial[...]
What Are The Benefits of A Clinical Trial Management System?
Sep 5th, 2024 in
Glossary
A clinical trial management system (CTMS) streamlines clinical trial operations from startup to closeout. It centralizes protocols, subjects, and financials, enhancing efficiency and oversight. Clinical research professionals gain improved visibility into trial progress and[...]