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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,[...]

AI in Clinical Trials: Can It Move the Needle Faster?

Jan 7th, 2025 in Trends

Clinical trials have a median cost of $19 million, with the average cost exceeding $41 million per trial. Considering the majority of trials face delays—and these can cost anywhere from hundreds of thousands to millions of dollars per day—there’s no shortage of incentive to[...]

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: [...]

How the Clinical Research Staffing Model Is Evolving

Dec 11th, 2024 in Trends

Traditionally, many professionals fell into clinical research by chance, starting at entry-level positions in the field and gradually progressing through the ranks. Now, we’re seeing a shift to a more intentional approach, where four-year bachelor degrees in clinical research[...]

CTMS vs. eTMF: Why Understanding and Integrating These Systems Matters

Dec 5th, 2024 in Glossary

In clinical trials, efficient operations and detailed documentation drive success. A clinical trial management system (CTMS) and an electronic trial master file (eTMF) are two foundational elements, each with distinct purposes. CTMS focuses on operational oversight, while eTMF[...]

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[...]

How Electronic Data Capture Is Shaping the Future of Clinical Research

Nov 13th, 2024 in Glossary

*In clinical research, case report forms (CRFs) and electronic data capture (EDC) systems are often used interchangeably. In the context of this article, CRFs refer to the forms that collect the required clinical data for analysis—the actual data points. The EDC system is the[...]

3 Good Reasons To Diversify Your Clinical Research Site Network

Nov 7th, 2024 in Good Clinical Practice

Over the past five years, the clinical research industry has experienced a surge in merger and acquisition (M&A) activity, driven by the need for scale, technological integration, and diversification of capabilities. Companies like Centricity Research and The IMA Group have[...]

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 Causes Delays in Vaccine Trials?

Oct 22nd, 2024 in Vaccines

Vaccine trials are critical to public health, but they are also complex and highly scrutinized. When delays occur, they can have far-reaching consequences, from prolonged time-to-market to increased costs. If your vaccine trial has gone “off the rails” so to speak, it’s crucial[...]

Lyme Disease in Ohio: Causes and Clinical Trials

Oct 11th, 2024 in

Lyme disease is on the rise in Ohio and its border states due to an increase in the population of adult blacklegged ticks, also known as deer ticks. While antibiotics can treat the infection, Lyme disease can still cause both short-term symptoms and potentially lingering[...]

Clinical Trial Data Management Best Practices For Sponsors and CROs

Oct 2nd, 2024 in Glossary

Effectively managing clinical trial data is crucial for maintaining research integrity and compliance. Researchers typically use clinical trial management systems (CTMS) to orchestrate trial operations, and integrate with electronic data capture (EDC) for centralized data[...]

Empowering Acceptance: Supporting Alopecia Awareness Month

Sep 12th, 2024 in Dermatology

September is Alopecia Awareness Month, an opportunity to educate others about alopecia areata, a common autoimmune condition that causes hair loss on the scalp, face, and body. As we deepen our understanding of this condition, we can support and uplift those affected, helping to[...]

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[...]

Good Clinical Practice Principles for Sponsors and Investigators

Aug 20th, 2024 in Good Clinical Practice

Good Clinical Practice (GCP) serves as the foundation for maintaining patient safety and data integrity, providing a framework that safeguards patients while facilitating scientific advancements. In this post, we’ll highlight good clinical practice principles and examine recent[...]

10 Milestones in The History Of Vaccines

Aug 10th, 2024 in Vaccines

August is National Immunization Awareness Month, a time to reflect on the importance of vaccinations and ongoing vaccine research. Vaccines are among the most important weapons in the public health arsenal. They have significantly reduced the occurrence of preventable infectious[...]

Trends in Pulmonary & Respiratory Medicine: Insights from Dr. Roy St. John

Jul 17th, 2024 in Pulmonary

With over three decades of experience and a distinguished career, Dr. St. John brings invaluable expertise to our research initiatives. We recently met with him to discuss the latest trends in pulmonary and respiratory medicine, including biologics, triple inhalers, and[...]

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