Glossary:
AI and Machine Learning in Clinical Trials: A Guide for Sponsors
Dec 10th, 2025 in
Glossary
Artificial intelligence (AI) and machine learning (ML) have become an integral part of clinical trial operations. While these technologies are sometimes lumped together, their roles and functions are distinct yet complementary. This overview explores where we’re seeing the most[...]
Artificial Intelligence’s Role & Impact in Clinical Data Management
Nov 18th, 2025 in
Glossary
For decades, clinical data management (CDM) was built around linear, labor-intensive workflows. Teams manually reviewed case report forms, tracked down discrepancies, and cleaned data through rounds of queries and reconciliations. The process was reliable but slow, and with[...]
Long-Term Side Effects of Ozempic: What Clinical Researchers and Sponsors Should Know
Sep 30th, 2025 in
Glossary
Ozempic (semaglutide) is a GLP-1 receptor agonist initially approved for managing type 2 diabetes and now also prescribed—under various brands—for chronic weight management. Its benefits are clinically meaningful: improved glycemic control, cardiovascular risk reduction, and[...]
A Practical Guide to Risk-Based Monitoring in Clinical Trials
Sep 16th, 2025 in
Glossary
The pace and complexity of clinical trials continue to grow, along with the cost of inefficiencies. For some time now, conventional site monitoring has overly relied on resource-heavy routines that prioritize quantity over quality. But risk-based monitoring (RBM) has emerged as[...]
Automation in Clinical Trials: A Practical Framework for Faster, More Reliable Trials
Sep 3rd, 2025 in
Glossary
As clinical trials evolve, so do the tools and technologies that support them. With increasing protocol complexity, decentralized and hybrid models, and demand for real-time data, sponsors and CROs need systems that enable consistency, accuracy, and speed across trial sites. [...]
The Rising Value of Clinical Trial Business Intelligence
Jul 29th, 2025 in
Glossary
Clinical trials generate a tremendous volume of data. But what matters is the ability to draw timely, meaningful insights and act on them with confidence. Once used primarily for retrospective reporting, business intelligence (BI) now plays a central role in guiding decisions at[...]
Clinical Safety Data Management: How Sites Protect Patients and Maintain Trial Integrity
Jul 22nd, 2025 in
Glossary
When a patient experiences an unexpected complication in a clinical trial, everything changes. Clinical safety data management—the structured process for documenting, evaluating, and reporting adverse events (AEs) and serious adverse events (SAEs)—is what guarantees those[...]
eConsents: Modern Standard for Clinical Trial Consent
Jun 10th, 2025 in
Glossary
Digital innovation has transformed the way clinical trials operate—and part of that is the informed consent process. eConsent, or electronic informed consent, is gaining traction as a standard for clinical research that prioritizes accessibility, compliance, and participant[...]
Electronic Patient Reported Outcomes: Improving Data Accuracy and Patient Engagement
May 13th, 2025 in
Glossary
In modern clinical trials, participant-reported data is essential for evaluating treatment safety, efficacy, and tolerability—especially in studies where symptoms, side effects, or quality of life play a central role. Electronic patient-reported outcomes (ePRO) systems[...]
Translational Research: Turning Scientific Discovery Into Real-World Impact
Apr 8th, 2025 in
Glossary
Translational research plays a vital role in modern medicine by moving discoveries made in the lab into the clinic, where they can directly benefit patients. As a bridge between scientific innovation and real-world healthcare, translational research shortens the time it takes[...]
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)—also referred to as clinical trial management software—streamlines clinical trial operations from startup to closeout. It centralizes protocols, subjects/patients, and financials, enhancing efficiency and oversight. Clinical research[...]