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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Cultivating A Bespoke Recruitment Strategy For Your FSP Partnership
Pharmaceutical organizations and service providers employ diverse recruitment strategies. Explore how a multifaceted approach to staff recruitment can greatly speed up clinical trial success.
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Direct-From-Patient Data Capture With eCOA5/2/2022
Learn how an eCOA tool can provide patients a chance to be heard while giving sponsors quantitative and qualitative data to track the efficacy of a treatment.
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Trial Summaries: Improving Patient-Centric Communications8/14/2023
Consider this alternative approach to distributing trial results summaries to participants that takes advantage of commonly used technologies.
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Top Therapeutic Areas In The Asia Pacific Clinical Trial Landscape1/6/2023
Explore why the Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient population, and the availability of top clinical institutions as trial locations
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Achieving Excellence In IO Clinical Trials6/21/2023
Immuno-oncology therapies have revolutionized the treatment of cancer patients worldwide. Learn how to plan for success and reduce risk when developing novel treatments for patients with cancer.
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Solving The EHR-To-EDC Challenge: A Scalable-First Approach8/14/2023
Unearth how industry shifts, technology adoption, and interoperability openness are paving the way for scalable solutions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Global Phase 3 Study Rescued In Record Time2/28/2023
DSG was selected as the preferred vendor for providing global support and enhanced data quality. Find out how the company was able to dramatically improve database build and study conduct.
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Case Study: Global Oncology2/1/2024
Scout's transportation, expense reimbursement, and time and wage loss compensation helped an oncology study recruit and retain hard-to-reach patients.
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Patient Insights Informed Consent Engagement9/18/2023
By incorporating the patient viewpoint throughout the informed consent process, discover how this technical solution enhanced the overall patient experience within clinical research operations.
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Global Resourcing Maximizes PV Operations To Meet Timelines1/16/2024
Explore how clients were able to leverage the extensive resources of PPD FSP Pharmacovigilance globally, maximizing their PV operational delivery model and successfully meeting ambitious timelines.
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Best Practices For Changing From One eClinical Vendor To Another10/24/2023
Switching solution providers mid-study isn't uncommon. But how can teams avoid schedule delays, interrupted operations, and errors? Learn best practices from this example by Signant Biotech.
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Completing Recruitment In 4 Countries In A Study For ED11/10/2023
Uncover how a leading Eastern European CRO completed patient recruitment ahead of schedule in an erectile dysfunction study involving the evaluation of an innovative MED3000 topical gel.
NEWSLETTER ARCHIVE
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.