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
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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
-
Robust Models For Supporting PV And Medical Information Activity
Learn how outsourcing local pharmacovigilance and medical information activities to an established safety organization can provide high-quality expertise and technology that meets demand.
-
Tips For Tailoring eConsent For Optimal Patient Centricity3/29/2022
While informed consent is a critical process for ensuring participant autonomy, consent forms are too long, unclear, difficult to read, and frequently exceed 9th grade reading levels. Explore why eConsent is a potential solution to this problem.
-
Mobile Application Considerations For Clinical Trials And Beyond8/28/2023
Delve into fundamental definitions, navigate through the regulatory landscape, and examine common applications of mobile apps in research.
-
How Biotechs Are Using DCT Technology To Conduct Trials In The APAC Region9/22/2022
In this white paper, gain insight into how the Asia Pacific region, with its rapid growth of clinical trials, presents a great opportunity for conducting clinical research and has become the preferred destination for DCTs.
-
7 Considerations For eCOA Technology Solutions3/3/2023
Choosing the right vendor, solution, and deployment model is critical for a clinical trial to be successful. As a sponsor, consider these seven best practices when selecting the best eCOA.
-
Modernizing Direct-To-Patient Clinical Trials5/20/2022
This paper provides an overview of factors underlying the rapid and ongoing modernization of clinical trials and provides a short discussion of DtP trials and demonstrates how they can solve some of the difficulties you may be facing today.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
A Leading Academic Medical Center Monitors Newly Diagnosed Myeloma Patients5/20/2022
Learn how eCOA helped to motivate patients and increased engagement around experiences outside of the clinical setting, which otherwise may have gone unmentioned.
-
Validating New Identification Algorithms With Objective Criteria & Clinical Trial Data7/19/2023
Learn how researchers and clinicians can make better-informed decisions to advance patient care and enhance public health outcomes related to myocardial infarction.
-
Delivering Clinical Trial Management Oversight6/27/2022
Learn how clinical quality services were used to assess and mitigate study startup risks and identify key issues and concerns in clinical operations and clinical trial management process areas.
-
Imunon Phase IB Ovarian Cancer Study Shows Strong Progression-Free Survival Treatment Effect Using A Synthetic Control Arm12/8/2022
Explore how Imunon used a control arm among stage III/IV ovarian cancer patients in their clinical trial.
-
Comparator Drug Sourcing Solutions: Network Effects5/5/2022
A well-known, mid-size, multi-national pharmaceutical company needed a large supply of comparator drug to begin comparative clinical trials for a rare disease.
-
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.
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
-
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.
-
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.
-
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
-
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.
-
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.
-
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.