A few decades ago, the development of global clinical research that integrates low- and middle-income countries was considered a dream. Now it is a pressing need. This article discusses the history of vaccine research in Latin America, how the region could help solve the vaccine clinical trial diversity problem in the U.S., and why the region is a desirable destination for such clinical research.
- Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
- Decentralized Clinical Trials: Key Considerations For Sites & PIs
- Takeda Takes A Strategic Approach To TMF
- How To Navigate Drug Repurposing And Bridging Studies
- How To Build A Strong CRO Partnership And Find Drug Development Success
- What Should You Look For In A CRO Partner?
- Clinical Trial Duration Trends & The Study Closeout Gap
GUEST COLUMNISTS
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Clinical Trial Duration Trends & The Study Closeout Gap
Clinical study durations are increasing. Contributing significantly is what we will refer to as a study closeout gap. Is your company positioned to reverse this trend and reduce time to market for your new drugs and therapies? This article explores study duration data as well as related labor challenges and macroeconomic trends.
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How To Leverage RWE To Facilitate Access To Cell & Gene Therapies
As more and more cell and gene therapies hit the market, the already intense pressure to figure out how to pay for them will only increase. This article shares how real-world evidence (RWE) can be leveraged to help offset economic uncertainties, facilitate access, and create a sustainable foundation for long-term data generation.
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Improving Diversity In Clinical Trials With A Community-Based Approach
Executives of clinical trial sponsors and CROs must acknowledge that the current system fosters inequities such as decreased access and poorer healthcare outcomes for historically underserved patient populations. By committing to a community-based approach to enhance clinical trial diversity, we can further enable improved healthcare outcomes for all.
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Latin America: A Compelling Region To Conduct Your Clinical Trials
This article examines the need to conduct clinical trials outside the U.S., addresses the recruitment crisis in the U.S., reviews the incentives for clinical trials overseas, and explores the growth of clinical trials in Latin America. Colombia is highlighted as a country that stands out as ripe with opportunity.
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IVDR Compliance: You May Need To Rethink Your Clinical Evidence Strategy
European notified body feedback reveals that the biggest gaps in In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) submissions are being found in clinical evidence, particularly around clinical performance data. Also covered in this article is discussion of overlap between EU and FDA requirements.
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How Can We Investigate Biomarkers For Lung Cancer Patients More Effectively?
With a 5-year mortality rate of nearly 90%, lung cancer is in dire need of targeted control interventions. There is a serious lack of sufficient predictive biomarkers, turning the lung cancer journey into one in which the patient and physician alike may as well be wearing blindfolds. This article discusses how we can start to swing the needle in the patient's favor.
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Making An Unapprovable Drug Product Approvable: Lessons Learned
This true story explores a drug product that was in the middle of Phase 3 trials, generating the keen interest of the FDA, but which suffered a commercialization setback due to manufacturing inefficiency and safety concerns. They asked us to think about how we would transform the manufacturing process into a licensable process.
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New Clinical Studies In ALS Show Promise
Right now, there is no cure for amyotrophic lateral sclerosis (ALS) and approved therapies only moderately slow progression of the disease. However, new clinical studies are taking new approaches to targeted therapy, including using a platform trial design, investigating secondary endpoints, and using brain-computer interfaces.
CLINICAL TRIAL WHITE PAPERS
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5 Ways That Decentralized Clinical Trial Approaches Can Reduce Study Costs
Technological innovations have enabled the adoption of decentralized and hybrid clinical trial models (DCTs) at scale. Still, there persists the notion that this kind of expansion will make trials more expensive. Following are five ways in which DCT approaches can help to save money.
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Avoid Critical Findings In Your TMF - A Review Of MHRA Findings4/14/2021
In clinical research, there is great emphasis on the TMF being inspection-ready at all times. However, regulatory agencies still encounter critical findings in the TMF during inspection. The MHRA recently published their annual GCP Inspections Metrics Report covering metrics from April 1, 2018, to March 31, 2019, which include what issues were found during inspections. In this white paper, we take a look at the most common TMF issues and how to avoid them.
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Navigating The Complex Realities Of Biomarker Testing In Oncology3/22/2022
Gain insight into the rapidly evolving biomarker landscape in oncology, from clinical development to regulatory uncertainties to commercial implications, in this white paper.
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Manufacturing Software Buyer’s Guide3/4/2022
With so many manufacturing software products on the market today, evaluating and choosing the right one for your organization can be overwhelming. It doesn't have to be if you know the essential capabilities you need.
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Insights On Clinical Trial Enrollment: Where We Are As We Head Into 20222/14/2022
Explore the continued impact of the pandemic on clinical trial enrollment in Phase II and III studies to help the industry navigate the dynamic landscape in 2022 across four therapeutic areas (TAs).
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ALS Studies And Lessons Learned From COVID-192/2/2021
For ALS trial sponsors and CROs alike, the need to protect the health of study participants, the study team, on-site health care professionals, and the broader community in which the trial centers are located is of paramount importance. The question is, how to ensure this protection and conduct the trial? The answers lie in preemptive mitigation and adaptive processes that can be implemented flexibly as conditions evolve.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Leading Global Pharmaceutical Company Selects LifeSphere SUSAR Reporting5/27/2022
Discover how a leading global pharmaceutical company solved the problem of managed the distribution of safety reports by their clinical operations team.
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How Data Integration Saved Time And Increased Output10/27/2021
An established biotechnology company needed a technology partner to support them in implementing risk-based quality management and providing greater visibility into their data. In this case study, learn a risk-based approach with data visualization and communication that dramatically increased output and time savings.
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Using De-Identified Linked Real-World Data To Create An External Control Arm In Non-Small Cell Lung Cancer12/16/2021
A pharmaceutical company designed its Phase II study of a novel agent to treat metastatic non-small cell lung cancer driven by a rare subtype of EGFR genetic mutation. Discover the results in the available case study.
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Device Strategy For eCOA: BYOD Or Provisioned?4/6/2021
By asking the right questions, and understanding and preparing for all the variables, you can help a sponsor successfully implement the modality that increases patient compliance while minimizing missing data and risks to data integrity throughout the life of a study, even a long-term study.
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Medical Devices In Clinical Trials: Improving Study Outcomes6/21/2021
Amid growing availability, interest, and confusion around using sensors and other devices to improve clinical trials, this article offers a roundup of key considerations and compelling use cases.
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New Tumor Evaluation Modality5/31/2022
In this case study, learn how using intratumor RECIST (itRECIST) criteria can measure effectiveness of cancer therapeutics.
NEWSLETTER ARCHIVE
- 06.28.22 -- Overcoming Patient Recruitment And Retention Challenges In Rare Disease Studies
- 06.28.22 -- The Steps To Executing Gene Therapy Trials
- 06.27.22 -- SCRS Puts A Spotlight On Diversity
- 06.27.22 -- Industry Perception And Future Trends For Direct-To-Patient Supply
- 06.23.22 -- Making The Most Of Clinical Research
COVID-19 AND YOUR CLINICAL TRIALS
- UCB Uses Decentralized Trials To Manage Studies
- #NoGoingBack Supports Keeping Patients First
- X4 Pharma Adjusts Clinical Trials For A COVID World
- Lilly, Care Access Take COVID Trial Directly To Patients
- From Idea To Patient In 10 Weeks: NeuroRx’s Fast Track Approach
- 3 Steps To Get A Virtual Clinical Trial Up And Running
- Can Virtual Trials Maintain Their Momentum After COVID?
CLINICAL LEADER CONTENT COLLECTIONS

The articles in this e-book all relate to the challenge of CRO selection. We hope you enjoy them and learn from the insights contained in them.
More Content CollectionsFOCUS ON PATIENTS
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In this article we compare the 2020 and 2021 result of the WCG Avoca Industry Survey, which explores industry respondents’ views on patient diversity in clinical research participation.
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Executives of clinical trial sponsors and CROs must acknowledge that the current system fosters inequities such as decreased access and poorer healthcare outcomes for historically underserved patient populations. By committing to a community-based approach to enhance clinical trial diversity, we can further enable improved healthcare outcomes for all.
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For rare disease clinical trials, communications are enabled by working closely and effectively with patient advocacy organizations. In this article, a director of scientific and patient affairs shares 4 tips on what has helped their company overcome some of the barriers.
EMBRACING DIVERSITY & INCLUSION
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We are at the beginning of important conversations. Conversations that need to happen so we can definitively address the health disparities that continue to impact outcomes among ethnic and racial groups in the United States.
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Advancements of the protocols, tools, and technologies that were highly leveraged during the COVID-19 pandemic are the key to breaking down the barriers that perpetuate clinical trial disparities.
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To achieve better outcomes and health equity for historically underserved populations, we must address the not widely acknowledged, hidden, real-world reasons for such poor diversity in clinical trials. Here, we will pull back the covers on the issues we must tackle to improve diversity in trials.