There is a great opportunity for clinical supply chain practitioners to learn from their commercial peers. By adapting and adopting the right commercial best practices, clinical supply chains become more effective, cost-efficient, and agile in delivering the right treatments to the right patients.
- Enabling “Good” Clinical Research In LMICs With The Good Clinical Trials Collaborative
- FDA Introduces Quality Management Maturity Program
- 5 Straightforward Ways To Support New PIs
- 4 Pitfalls Of Poor-Performing Clinical Trial Teams — And How To Prevent Them
- Can DCTs Be Both Patient Centric And Financially Efficient For Sites?
- Pfizer To Provide Individual Participant Data At Scale
- Moderna Addresses Awareness Gap, Builds Community Trust To Boost CMV Trial Recruitment
GUEST COLUMNISTS
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Can DCTs Be Both Patient Centric And Financially Efficient For Sites?
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.
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Pfizer To Provide Individual Participant Data At Scale
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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Moderna Addresses Awareness Gap, Builds Community Trust To Boost CMV Trial Recruitment
Fewer than one in four Americans are aware of the leading cause of pediatric birth defects — a common and contagious viral infection known as cytomegalovirus, (CMV). Moderna aims to overcome this awareness gap and enroll patients in CMV trials using lessons learned from its COVID-19 clinical trials.
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Navigating The Hype Of AI In Clinical Research
When you consider the rising cost of healthcare in America, a shortage amounting to tens of thousands of physicians, and economic headwinds stirring fear across the field, we can’t afford to not use AI. We shouldn’t be asking ourselves questions of why, but rather, why not. But that begs a new question: Why haven’t we seen the impact, adoption, and value of AI more broadly across clinical research?
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Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.
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Best Practices For Identifying And Partnering With Patient Advocacy Organizations
When considering best practices for identifying and partnering with patient advocacy organizations (PAOs), it’s important to recognize that the process is a lengthy one that requires considerable forethought and planning. And why shouldn’t it be? In many respects, the work is similar to that performed by your colleagues in commercial and medical affairs.
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Establishing TMF Quality Goals For Greater Trial Efficiency
Does your clinical development group rely on its TMF as a resource for designing and conducting trials efficiently? Would maintaining timeliness in filing complete, ALCOA-compliant documents to the TMF be enough if efficiency were a goal of every clinical trial? Consultant Ken Keefer discusses the importance of creating TMF quality goals to improve overall trial performance.
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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.
CLINICAL TRIAL WHITE PAPERS
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Unlocking The Potential Of Decentralized Clinical Trials
Explore the current DCT landscape and its evolution, as well as the key advantages of incorporating decentralized attributes and how barriers to their inclusion can be overcome.
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How Sponsors And CROs Can Fully Benefit From The Permanent Shift To Decentralized Home-Visit Clinical Trials8/26/2022
To aid sponsors and CROs in fully realizing the benefits of decentralized clinical trial methods moving forward, this whitepaper extracts the lessons learned from the pandemic and their implications for clinical trials now and in the future.
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Rare Disease Trial Strategies2/15/2022
This white paper focuses on clinical trials, aligning the latest trends in rare disease R&D viewed through the lens of gold-standard clinical intelligence. From this emerges practical recommendations regarding clinical trial design, stakeholder engagement, and patient recruitment.
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Peanut Allergy: Asia Pacific Clinical Trial Landscape1/6/2023
Explore the differences between the common food allergies in Asia and the West, specifically the peanut allergy.
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Trends And Challenges In Rare Disease Clinical Development3/2/2022
Looking back over the past few years and projecting forward, one of the strongest trends in the pharmaceutical industry centers on rare diseases. Learn some of the major themes, concerns, and challenges surrounding rare disease 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?
CLINICAL TRIAL APP NOTES & CASE STUDIES
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EU’s New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?5/16/2022
The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.
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Overcoming Rare Disease Clinical Trial Challenges3/17/2023
Understanding the rare disease framework is key to being able to offer study participants adapted solutions and positively contribute to clinical research.
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Nevro Eliminates Majority Of Source Data Verification With ePRO And EDC2/23/2023
Read how a global medical device company was able to unlock new efficiencies by implementing data collection via electronic patient-reported outcome assessments.
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How A Top 3 Global CRO Reduced The Impact Of CRA Hiring And Retention Challenges8/22/2022
Learn how a top 3 global CRO implemented technology to remotely connect with their research sites and can now monitor up to 50 sites per week, compared to the former average of two on-site monitoring visits per week.
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Overcoming Inventory Challenges For A Complex, Global Study7/14/2022
A CRO customer and a clinical sponsor both lacked an unblinded supply management role to oversee Interactive Response Technologies (IRT) platform supply strategies and monitor inventory levels.
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Outsourcers Are Feeling Uneasy About Continuity Of Supply4/14/2022
Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.
NEWSLETTER ARCHIVE
- 10.04.23 -- Biomarkers, E-Diaries, & Enrollment: Lessons From An E-cigarette Cessation Trial
- 10.04.23 -- Reliably Securing Patient Data
- 10.03.23 -- Risk-Mitigation Recommendations Based On FDA Guidance
- 10.03.23 -- Pharma Evolution: Digital & AI Begin Redefining Norms
- 10.02.23 -- AI's Potential To Improve Clin Ops, Trial Matching
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.