Discover four mistakes biotechs often make in haste (and how to avoid them) as they hurry through clinical trial contracting on the path to commercilization.
- Could Consolidating Independent Sites Into Site Networks Be The Research Revolution We Need?
- How Takeda Leverages Cultural Competency Training To Improve Diversity
- A Better Recipe For Sourcing Your Clinical Trial
- A Structured Approach To Regulatory Information Management Vendor Selection
- Supplying Complex, Controversial, And Intercontinental Clinical Trials
- 4 Takeaways From Building A Differentiated Franchise In Clinical Immunology
- Navigating China's Biologics Approval And Accelerated Pathways
GUEST COLUMNISTS
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4 Takeaways From Building A Differentiated Franchise In Clinical Immunology
Immunovant CEO Pete Salzmann, MD, MBA, shares what he and his young company have learned about developing the right workforce, selecting viable targets, listening to patient needs, and trying alternative trial designs.
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Navigating China's Biologics Approval And Accelerated Pathways
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Community-Driven Registries Drive Understanding Of Rare Diseases
In an effort to increase and diversify research, the Pulmonary Fibrosis Foundation (PFF) envisioned a new approach to aggregating usable medical data — asking patients directly.
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3 Tips For Selecting Your eTMF Platform
Each eTMF platform presents its own set of advantages and drawbacks. Be sure to incorporate these three tips when considering a new eTMF vendor and its services.
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2 Ways To Encourage Clinical Trial Investor Funding
Consider these two promising funding models that balance risk with reward: trial-specific fundraising and staged funding release.
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The Key Differences Between Expanded Access Programs And Investigator Sponsored Trials
Expanded access programs (EAPs) and investigator sponsored trials (ISTs) play significant roles. While both aim to provide patients with access to investigational therapies, they operate under distinct frameworks and serve different purposes. Understanding their differences from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.
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Best Practices For Complete Registration And Reporting Of Summary Results On ClinicalTrials.gov
The Clinical Trials Transformation Initiative (CTTI), alongside the FDA, investigated factors and barriers to registration and summary results information reporting. Here is what they found and what they suggest for ensuring complete reporting of trial results.
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Is Ignoring Gender Non-Conformity Research Holding Us Back?
Including individuals across the gender spectrum in clinical trials isn't just the right thing to do, it's also strategic move with benefits for science, society, and business.
CLINICAL TRIAL WHITE PAPERS
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Pharma Research, Development, & Launches Save Lives — & The Earth
Understand how a defined framework and way of measuring allows companies to align priorities, short- or long-term goals, and what ESG success looks like.
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The Biotech Landscape: Opportunities In China And The Path To USFDA Approval11/7/2022
In this white paper, learn why western biopharma companies should take advantage of China’s revamped regulatory framework.
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What 4 Things Do All eCOA Studies Need To Succeed?8/8/2023
Learn what else, in addition to good technology, study teams need for eCOA studies to succeed.
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Developing A Strategy To Optimize Study Supplies9/1/2022
Discover how the optimization of a clinical supply strategy can decrease wasted supplies, drive down costs, and ensure supplies reach the sites on time and in the correct quantities.
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Mission: Control Site Payments2/22/2023
Discover how this payment automation software is bringing clarity, consistency, and control back to site payment processes.
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Cell And Gene Therapy Logistics Management: A Holistic Approach7/12/2023
Learn to recognize essential logistics requirements to create a holistic and comprehensive approach to logistics management that successfully addresses the spectrum of complexity across all CAGT assets.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Achieving Healthy CRO Growth Through Agility9/19/2023
Discover how George Clinical, a contract research organization based in Sydney, Australia, achieved robust CRO growth by harnessing the power of agility with Merative.
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Rater Training And Central Rating Services Optimize Signal Detection8/8/2023
Explore this comprehensive case study to learn how one sponsor's movement disorder trial was able to optimize signal detection of a primary endpoint using clinician ratings of abnormal, involuntary movements.
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Alzheimer’s Study Involving Home Infusions Exceeds Expectations2/22/2023
Gain insight from this Phase 3 global clinical trial focused on pre-clinical Alzheimer’s Disease where adult patients received one-hour intravenous infusions every month for 4.5 years.
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Global Comprehensive Audit Support10/26/2023
Uncover how a pharmaceutical company and its strategic partners were able to provide oversight of key performance indicators relevant to the pharma's business model, which enabled escalation and remediation of any concerns.
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ClinCard Supports Tufts Medical Center’s Commitment To Care And Research2/17/2023
Administrative work is to be expected at any site. Explore how improved and efficient administrative processes can ensure a better experience for patients and the team.
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Proof-Of-Concept Study Enabled To Drive Novel Gene Therapy Program9/29/2023
Unearth how a natural history trial aimed at addressing the exceptionally rare neurological disease affecting pediatric patients with no existing treatment options was executed successfully.
NEWSLETTER ARCHIVE
- 03.18.24 -- Site Feasibility Tips For Cell And Gene Therapy Clinical Trials
- 03.15.24 -- How RBQM Has Evolved In Recent Years
- 03.15.24 -- Partners Serving Solutions For Patients And Sites
- 03.14.24 -- Taking Psychedelic Trials To Australia
- 03.14.24 -- Equitable Trials: Navigating Diversity In Clinical Research
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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Finding effective treatments for tinnitus has often been circuitous and frustrating for many patients. Tinnitus expert Marc Fagelson, Ph.D., explores the current treatment landscape and what can be done to improve outcomes for patients.
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Including individuals across the gender spectrum in clinical trials isn't just the right thing to do, it's also strategic move with benefits for science, society, and business.
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While recent efforts promote diversity in clinical trials, the lack of enforcement and tokenistic approaches risk leaving people of color behind. This article delves into the urgency of addressing this crisis and building genuine inclusivity for a healthier future for all.
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.