Remington-Davis:
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[...]
Choosing the Right Vaccine CRO Services To Accelerate Development
Feb 13th, 2025 in
Vaccines
There’s growing demand for vaccine CRO services, with numerous factors at play. The pandemic highlighted the need for rapid vaccine development. Platforms like mRNA, which revolutionized COVID-19 vaccines, are now being tested for other conditions. Initiatives have pushed for[...]
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,[...]
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[...]
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[...]
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[...]
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[...]