When Appili Therapeutics was ready to enter a Phase 3 trial for a COVID-19 treatment, the CRO selection process was tightly linked to the fact that the company would be conducting the study on infected patients during a global pandemic.
- UCB Uses Decentralized Trials To Manage Studies
- Why Did Veeva Become A Public Benefit Corporation?
- How Ionis Pharmaceuticals Is Advancing Multiple Late-Stage Trials During COVID
- AI And Machine Learning Prepare Pharma For The Data Onslaught
- Janssen’s Best Practices For Patient Diversity Success
- Zogenix Puts Focus On Safety In Seizure Patients
- Is AI Improving Outcomes In Clinical Trials?
GUEST COLUMNISTS
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The Asia-Pacific Region: A Hot Spot For Clinical Trials
The Asia-Pacific region has become the hot spot for conducting clinical trials. Why? There is an ease of regulatory compliance, a low cost of conducting studies, a growing patient population, and the presence of a few top clinical institutions acting as sites.
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Data-Driven Insights To Improve Your Recruitment Process For Clinical Trials
Recruitment of suitable patients for clinical trials is a challenge because they are sometimes driven by negative attitudes or a lack of information about clinical trials in general. Unfortunately, the probability that a patient will refuse to participate even after being well informed is considerable. exeo Strategic Consulting AG and Rogator AG performed a robust survey to learn more about why patients are willing or unwilling to participate in clinical trials.
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Insource, Outsource, Or Both? Choosing The Right Model For Your Clinical Workforce
While traditional full-service outsourcing is still prevalent (and practically required for small or virtual biotech companies), and some organizations continue to maintain permanent in-house clinical teams, many others — especially midsize and larger organizations — are increasingly taking advantage of other models.
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Turning Point In U.S. History: Our Chance To Do Better With Clinical Trials
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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An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials
An analysis of the recently released ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.
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You’re A Small Biotech — How Should You Implement A Pharmacovigilance System?
When it comes to implementing strong PV practices at your company, there are a variety of components and capabilities to put in place. I’ve been on both the Big Pharma and biotech sides of this debate. With this knowledge in hand, I can help answer some of the commonly asked questions raised about PV best practices.
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Moving Up The Ladder In Clinical Research: How To Develop Management & Leadership Skills
One of the biggest career jumps is from individual contributor to manager. Becoming comfortable with making more abstract contributions rather than providing tangible work and checking off your accomplishments is paramount.
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Harmonizing Clinical Trial Content In A Post-Pandemic World
For clinical trial transformation to achieve its full potential, the structure and content of clinical trial documents must change to facilitate data transfer, content reuse, and predictability of information flow to support more efficient trial conduct by sites and sponsors.
CLINICAL TRIAL WHITE PAPERS
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Fusing Specifications And Design For Data Collection Casebooks With Veeva Vault EDC
Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.
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Virtual Approaches In Oncology Clinical Trials During COVID-19 And Onward
Patients living with cancer are among the most vulnerable during the pandemic, but sponsors and researchers understand oncology drug development must continue. This paper will discuss how COVID-19 is driving change in the oncology trial landscape and how these insights may shape the future of post-pandemic clinical development. Given the unique concerns of cancer patients, the scope of the discussion will focus on outlining innovative and flexible tech-enabled approaches and operational adjustments that can improve the patient experience.
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Commercialization Accelerator For Emerging Companies
For any life sciences company bringing its first product to market, the “commercialization to-do list” is long and punctuated by one critical strategic decision after another. This guide explores lessons learned from industry leaders facing the challenges of building commercial operations capabilities and how they avoid pitfalls.
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10 Tips For Writing Compliant Clinical Trial Participant Materials
Recruitment materials are a potential participant’s first introduction to the study, and post-consent materials can influence an individual’s decision about continued participation. It is important to adhere to the principles of participant protection, allowing participants to make informed decisions about what is in their own best interest, with the materials that appear at the earliest stages of recruitment as well as through the life of the study. Well-informed prospective and current participants lead to improved recruitment and retention rates.
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Vital Tools For Centralized Statistical Monitoring Of eCOA/ePRO Data
As the industry moves to adopt patient-centric approaches to clinical trials, there is an opportunity to adopt the best practices of QbD and risk-based methodologies to ensure that patient reported data are effectively being monitored. In this paper, we discuss the value of using advanced technology — specifically Centralized Statistical Monitoring technology - to oversee subject safety and data quality/integrity in a risk-based manner.
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Removing Barriers: Reimbursement And Compensation For Participation In Oncology Clinical Trials
Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question. Read this white paper to learn the impact that participant payments may play on clinical trial recruitment.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Insmed’s Fast And Successful EDC Study Builds With Veeva Vault CDMS
Insmed describes the critical success factors enabling them to incorporate significant protocol changes and still hit their FPI deadline with Vault EDC.
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Comparative Analysis For Non-IND Sites
A cancer research organization that facilitates the conduct of multi-national clinical trials was deep in the planning and
coordination of a Phase III drug trial. The sponsor wanted to expand the trial to include German sites and had established important in-country partnerships for this purpose. The trial was being conducted under an IND, and everything was going according to plan until German regulatory authorities changed the rules. Read how Advarra Consulting provided in-depth analysis of German, European, and US regulations, allowing the cancer research study to move forward. -
Warming Up To Hybrid Trials
In a November 2020 survey, Industry Standard Research (ISR) asked 121 clinical trials outsourcers at sponsor companies a series of questions about their company’s use of hybrid trials. This article offers insight on prevalence of use, respondents’ overall impressions, and the concerns and downsides of hybrid trials.
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How To Cut The Negative Impact Of Protocol Amendments
When planning a clinical trial it’s common for sponsors to overlook or underestimate the possibility of protocol amendments. The COVID-19 outbreak has shown the inflexibilities of much of the clinical trials industry. Read how having a CRO that can remain focused on being agile and flexible can minimize the impact of protocol amendments on your trial.
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Key To A Faster, More Flexible Clinical Trial Process
How a single, integrated data analytics and visualization platform, supported by an experienced partner, can help you move your investigational product to market more quickly.
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Delivering The Global Expertise Required To Coordinate A Pediatric Gene Therapy Trial
A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.
NEWSLETTER ARCHIVE
- 03.03.21 -- An Experienced CRO And Sites Lead To Patient Recruitment Success
- 03.02.21 -- Maximizing Sourcing And Supply Chain Efficiency To Avoid Shortages
- 03.01.21 -- 10 Years Of Progress In 10 Months: 2020 Was A Reset Year For Pharma
- 03.01.21 -- Challenges And Considerations For Temperature Control
- 02.25.21 -- The Critical Role Of Sample Tracking In Clinical Trials
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 effort to protect trial participants during a global pandemic led many companies to adopt technologies they had not used in the past. One of those is virtual or decentralized trials. In this collection of articles from Clinical Leader, learn how sponsor companies are adapting to the new normal in clinical trials and reducing risk while creating tomorrow’s new study paradigms.
More Content CollectionsFOCUS ON PATIENTS
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Best Practices For Implementing Decentralized Clinical Trials
While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms.
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Lessons For Leaders: The Loud And Lasting Impact Of COVID-19 On The Future Of Clinical Research
Last year, shortly before the pandemic, we predicted that clinical trials of the future would be more open, more human-centered, and more integrated in the healthcare ecosystem, providing guideposts for how industry will adapt along these three themes. COVID-19 has both accelerated these trends and highlighted new challenges for R&D leaders to address.
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Janssen’s Patient-centric Approach To Psychiatric Disease Management
Diseases as complex as those of the brain require an equally complex approach, centered on the unique needs, goals, and circumstances of the individual patients, as well as the loved ones who support them. Listening, empathizing, understanding — these basic human interactions will have a critical role in our ability to reach our goal and deliver transformational medical innovations.
EMBRACING DIVERSITY & INCLUSION
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Turning Point In U.S. History: Our Chance To Do Better With Clinical Trials
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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Addressing Disparities And The Democratization Of Clinical Trials
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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Let’s Tackle The Hidden Real-World Reasons For Poor Clinical Trial Diversity
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.