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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[...]

Cost of Clinical Trials: Where Overspend Happens and How To Curb It

Dec 2nd, 2025 in Metrics

Conversation around healthcare costs often centers on drug prices. What tends to be overlooked is the cost of getting a drug to market in the first place. Clinical development continues to be one of the largest and most variable cost drivers in the entire drug lifecycle. A[...]

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[...]

Advances in COPD Treatment: A New Chapter in a Long-Fought Battle

Nov 11th, 2025 in Pulmonary

Chronic obstructive pulmonary disease (COPD) remains a major public health concern in the United States. In 2021 alone, thedisease claimed more than 138,000 lives, making it the sixth leading cause of death overall and the fifth leading cause of death from disease. Yet amid[...]

The Promise and Limits of AI Clinical Trial Recruitment

Oct 28th, 2025 in Trends

In the past year, Cleveland Clinic has made headlines for its strategic adoption of artificial intelligence across multiple areas of care and operations, from AI-powered structural heart tools through DASI Simulations to AI-driven revenue cycle management via AKASA. But another[...]

Why Is Patient Education Important in Clinical Research?

Oct 16th, 2025 in Patient Experience

Clinical trials are designed to test new treatments, yet for participants, the experience can be just as much about learning. At Remington-Davis, we’ve found that when you prioritize patient education during a study, it not only supports retention and compliance; it also equips[...]

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 Higher Purpose: Reframing Clinical Trial Participation as Service

Sep 23rd, 2025 in Patient Experience

People join clinical trials for many reasons. Sometimes, it’s to access treatment that isn’t yet available through traditional care. Sometimes it’s out of a willingness to try something new when standard therapies no longer work. And sometimes, it’s out of a desire to simply[...]

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[...]

4 Areas to Assess Clinical Trial Site Performance

Sep 10th, 2025 in Metrics

Choosing the right clinical trial site is a critical decision for pharmaceutical companies, but it’s only the beginning. Once the trial begins, how do you know your site is truly performing? Sponsor confidence in trial performance can’t be based on gut feeling or good[...]

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 Five-Star Experience: Setting a New Standard for Patient-Centricity in Clinical Trials

Aug 12th, 2025 in Trends

Participating in a clinical trial is a big commitment. It’s a decision that often requires patients to rearrange their work schedules, find transportation, fast before appointments, or spend hours away from home, all while navigating unknowns common to treatment and research. [...]

COPD Clinical Study Recruitment: Why It’s Challenging & How To Streamline It

Aug 5th, 2025 in Immunology

Recruiting patients for any clinical trial presents challenges, but chronic obstructive pulmonary disease (COPD) clinical studies are especially difficult. From diagnostic gaps to physical limitations and socioeconomic barriers, the COPD patient population is one of the most[...]

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[...]

FDA Job Cuts Could Disrupt Clinical Trials

Jul 24th, 2025 in Trends

Over the past several months, the Food and Drug Administration (FDA) has seen a wave of high-level departures and widespread staff reductions — part of a broader government effort to reduce the Department of Health and Human Services (HHS) workforce by 10,000 jobs. In April of[...]

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[...]

How Patient Recruitment Software for Pharma Trials Supports Site Success

Jul 15th, 2025 in Glossary

Recruiting patients for clinical trials remains one of the most resource-intensive and timeline-sensitive aspects of study execution. Even with increased awareness and decentralized trial models, many studies still face enrollment shortfalls that threaten data integrity and[...]

What Private Equity’s Rise in Clinical Research Means for Sites, Sponsors and Trial Outcomes

Jul 9th, 2025 in Trends

There has been a sharp uptick in recent years in private equity acquisitions of locally owned research sites. Backed by goals for greater scale and operational efficiency, these firms are assembling site networks that span geographies and specialties. But as this trend[...]

In the Age of AI, Patient-Centric Clinical Trials Must Stay Human at Heart

Jun 24th, 2025 in Trends

The future of clinical research is arriving faster than we imagined. With artificial intelligence now at the center of conversations between OpenAI and the FDA, the industry is on the cusp of a major transformation. There’s growing excitement about how AI could streamline drug[...]

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[...]

The Rise of Rare Disease Clinical Trials: Trends, Challenges and What Sites Are Learning

Jun 4th, 2025 in Trends

Rare diseases may affect only small pockets of the population, but in clinical research, they make an outsized impact. In fact, 45% of global trial starts in 2024 were focused on rare diseases, according to theIQVIA Global R&D Trends report. Once considered too specialized or[...]

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[...]

Clinical Trial Data Visualization: Turning Complexity Into Clarity

May 6th, 2025 in Glossary

Clinical trials generate vast amounts of data, from patient demographics and laboratory results to device-captured metrics and adverse event reports. As trials increase in complexity, interpreting this data quickly and accurately has become essential. That’s where clinical trial[...]

The Real Cost of Cutting Funding for Vaccine Research

May 1st, 2025 in News

In a time when global public health still reels from the aftershocks of the COVID-19 pandemic, the U.S. is facing a new crisis — one that’s quieter but just as dangerous. Recent federal cuts to funding for vaccine research have sparked concern among medical experts, foreign[...]

From Compliance to Connection: Community Engagement For Clinical Trials

Apr 24th, 2025 in Trends

As pressure grows for clinical research to be more representative, one thing is becoming increasingly clear: true inclusion doesn't start with recruitment goals, but rather relationships. In the latestSite Landscape Surveyfrom the Society for Clinical Research Sites (SCRS),[...]

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 the Right Site Supports Efficient Clinical Trial Start-Up Activities

Apr 1st, 2025 in Glossary

Selecting the right research site is one of the most important decisions in a clinical trial startup. A well-chosen site does more than just provide a location—it serves as a strategic link to a partnership that streamlines operations, expedites approvals, and keeps patient[...]

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[...]

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)—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[...]

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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