While DCTs have the potential to provide more convenience and improved access for patients, the anticipated cost savings touted for these trials have yet to materialize fully at the site level. In fact, the opposite has occurred in some instances.
- Navigating The Hype Of AI In Clinical Research
- Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
- Best Practices For Identifying And Partnering With Patient Advocacy Organizations
- Establishing TMF Quality Goals For Greater Trial Efficiency
- Is Being Competent And Qualified The Same Thing In The GCP World?
- RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)
- Pursuing Smaller, Faster Clinical Trials For Progressive Neurological Disorders
GUEST COLUMNISTS
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Is Being Competent And Qualified The Same Thing In The GCP World?
When it comes to Good Clinical Practice principles, the mention of "competence" is underwhelming. Yet, there is plenty of talk about education, training, and experience. Is "competent" and "qualified" synonymous? Does one imply the other? And why does it matter? Kamila Novak of KAN Consulting explores and explains.
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RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)
Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor, discusses the findings of the groups’ joint global research study with CluePoints and Price Waterhouse Cooper (PwC), the implications of the upcoming ICH E6(R3) guidelines, and the future of risk-based clinical trial conduct.
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Pursuing Smaller, Faster Clinical Trials For Progressive Neurological Disorders
Current progression measures of neurodegenerative disease are clinically focused, highly subjective, and can take years to reveal the effects of therapeutic intervention. Knowing that, the pursuit of smaller and faster clinical trials, particularly at the proof-of-concept stage, can be an innovative way to counteract some risks and sidestep the limitations of larger trials.
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Vulnerable Populations Need Safer, More Effective COVID-19 Antivirals
Although COVID-19 is no longer a public health emergency, elderly and immunocompromised individuals remain vulnerable to severe outcomes. Drug developers. therefore, must adapt to deliver next-gen oral antivirals through clinical trials that incorporate the lessons we have learned during the pandemic and address the needs of these high-risk patients.
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An Overview Of The 9 FDA Special Designations for Pipeline Drugs
The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. While some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. Let's look at each of the nine special designations and what scenarios or drugs/therapies are best suited for each.
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Patients Are Speaking, And We Must Listen
Maimah Karmo knows all too well the importance of speaking up for oneself. Here, the president and CEO of Tigerlily Foundation shares what drove her to create the nonprofit and why she won't stop advocating for patients.
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What Do You MENA? The Arab World And Its Opportunities For Clinical Research
Looking beyond the imperative of involving more Arab Americans in clinical trials, there’s more to be said about involving the Middle East and North Africa (MENA) region in clinical research. Arab Board of Clinical Research Chair and President Hadi Danawi, Ph.D. explores the challenges to and benefits of conducting clinical trials in this underserved region.
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Cautious Optimism For Biotechs And Their Outsourcing Partners
Pre-revenue, including preclinical and clinical stage, biotechs have been the most impacted but also stand to gain the most after the economic downturn and subsequent recovery. This article will delve into how small to midsize pre-revenue biotechs have been specifically impacted and what this could mean for organizations that support them.
CLINICAL TRIAL WHITE PAPERS
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Managing Change In Clinical Trials: The Data Management Playbook
The need to manage change in clinical trials is unavoidable. Learn how to best plan for change related to the most critical element of trials – the data to support a therapy submission – can save substantial time, money and resources.
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Survey Results – Are Patients Ready For Decentralized Clinical Trials?10/27/2021
In this white paper, Estelle Haenel, Kayentis Medical Director and Basile Trimbur, Kayentis Medical Assistant, interview Trishna Bharadia to get her feedback regarding the results of the study exploring patients' readiness for remote clinical trials.
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Moving Beyond Traditional CTMS To Unlock Value In An Outsourced Model12/13/2022
The proliferation of data sources and the rise of outsourced trials has changed how CTMS is defined. What role does a CTMS play in the modern-day clinical trial and are you future-ready?
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On-Demand Payment Technology Offers Accuracy, Speed, & Transparency4/19/2023
Review current grant payment practices and how new software tools can transform the process, efficiently solving the problem that first gave rise to sponsor-funded escrow accounts.
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Machine Learning To Drive Clinical Trial Efficiency8/16/2023
Read on as authors explore accessing real-time clinical trial data for proactive study management, using adverse event data to enhance safety and performance, and tools to improve design.
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State Of Clinical Inventory Management At Sites5/15/2023
Did you know that 75% of clinical research sites keep track of their inventory using spreadsheets and paper? Understand the challenges sites face when handling inventory and how to overcome them.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Gaining Regulatory Approval Following A Single-Arm Phase I/II Study3/23/2022
A small biotech company engaged Veristat early in clinical development for help with a novel biologic being tested for treatment of an ultra-rare and aggressive hematologic malignancy with no available effective therapies. Discover what happens in this case study.
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Learn How Sponsors Can Achieve Demographic Goals Faster8/3/2023
Discover how Sitetrove’s proprietary Investigator Prioritization tool and Patient Proximity filter enabled this sponsor to zero in on investigators, their types of trials, as well as patient demographics and location.
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Flexibility Drives Progress In A Rare Disease Gene Therapy Trial9/6/2023
Uncover deployed methods and actions that were used to help a biotech company address clinical operations challenges and meet changing requirements.
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GDPR Implementation Support2/17/2022
Find out how identifying, implementing, and adopting ongoing GDPR compliance initiatives without disruptive impacts to current Eurozone customers was achieved in this case study.
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Prepare For The PhRMA Code On Interactions Revisions12/1/2021
The PhRMA Code is a voluntary code of ethics, relating to interactions pharmaceutical companies have with U.S. healthcare professionals. This code provides a collection of detailed rules, as well as broader principles, that have yet to be compiled into a comparable industry or government document.
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Large NCI-Designated Hospital System Trains 400 End Users, Resulting In Increased Levels Of Efficiency And Consistency6/28/2022
Learn how an eLearning solution was used to help overburdened trainers from a large National Cancer Institute (NCI)-designated hospital system.
NEWSLETTER ARCHIVE
- 09.21.23 -- New ICH GCP E6(R3) Draft Guidelines
- 09.21.23 -- Transforming Clinical Trials: Innovations In Site Validation, Feasibility, And Collaboration
- 09.20.23 -- ARPA-H NITRO: An Osteoarthritis Cure Rocket Fuel Or TNT?
- 09.20.23 -- Navigating Operational Challenges Of Oncology Drug Development
- 09.19.23 -- Navigating The Hype Of AI
CLINICAL LEADER CONTENT COLLECTIONS

With the advent of decentralized clinical trials and the increased fascination and exploration with technology-assisted processes bringing new data — and more of it — the importance of intentional data collection cannot be overstated. Our latest ebook from Clinical Leader brings you helpful articles on a topic that is arguably the most crucial part of the study process.
More Content CollectionsFOCUS ON PATIENTS
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Historically, clinical trial participants have rarely gained possession of their individual trial data. But now, that's about to change. Pfizer is announcing plans to return individual data to its participants beginning this year.
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Maimah Karmo knows all too well the importance of speaking up for oneself. Here, the president and CEO of Tigerlily Foundation shares what drove her to create the nonprofit and why she won't stop advocating for patients.
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Most clinical trials fail to meet timelines, and the delay is typically caused by lagging patient enrollment. Patient advocates and consultants Richie Kahn and Jenn McNary say failed recruitment efforts often have to do with a fundamental mismatch between how a trial is designed and patients’ actual wants and needs.
EMBRACING DIVERSITY & INCLUSION
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Clinical trials are essential for evaluating the safety and efficacy of new treatments before they are approved for use by patients. However, a new report from the International Longevity Centre (ILC), in collaboration with RBW Consulting, highlights a significant problem in the clinical trial process: the underrepresentation of older adults.
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The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.
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The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.