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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Synthetic Control Arm® In Clinical Trials
This white paper discusses the concept of the Synthetic Control Arm® (SCA®), which is a type of external control that is generated using patient-level data from patients external to the trial with the goal of improving the interpretation of uncontrolled trials, which can enable better product development decisions. A series of case studies are provided to highlight the different ways an SCA® has been used.
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Feasibility In Uncommon Populations: Balancing And Improving the Interests Of Patients, Sites, And Sponsors
This paper examines ways in which the approach to feasibility in rare, geographically dispersed populations has evolved, with particular attention to the perspectives of those stakeholders responsible for facilitating trial design and operations. How the research and development process approached that goal previously, modified the process recently, and continues to examine new directions for innovative solutions in the future is a focus of review.
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Evolution Of Treatment Of Atopic Dermatitis
The Atopic dermatitis (AD) treatment paradigm has significantly evolved in the last five years. Currently, AD is an area of intense focus for clinical developers. Globally, more than 100 pharmaceutical and biotechnology companies are investigating new therapeutic solutions for AD. This white paper will explore the pathophysiology of atopic dermatitis, as well as the rationale and mechanisms of action of existing and emerging therapies for AD.
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The H1N1 Study: Conducting Public Health Research During A Pandemic
This article describes Rho’s involvement in a recent clinical trial that assessed the safety and immunogenicity of the 2009 H1N1 vaccine in adults and children (aged 12-79 years) with severe asthma.
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Leading Change: Effectively Guiding The Organization Through A Study Start-up Technology Transformation
Automating study start-up enables faster site activation, better collaboration with study partners, and more informed decision-making. Learn about the common barriers to change and best practices to overcome them.
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EU GDP Guidelines: Implications For Shipping Clinical Materials Into The European Market
It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Multivigilance In The Cloud
Manufacturers must monitor how each product they sell performs with real patients as they use it outside the carefully controlled conditions of a clinical study. This process of multivigilance – the management of safety information for different kinds of medicinal products such as drugs, vaccines, medical devices, and combination products – is required throughout the entire product lifecycle. Continue reading to learn how cloud technology makes patient safety less expensive and more efficient.
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Expediting Path To Clinic With OptiForm® Total Supply
MGB Biopharma, a biotech company based in Scotland, U.K. was developing a new class of anti-infective medicine based on Minor Groove Binder compounds. Learn how Catalent provided integrated formulation development, clinical trial material manufacturing, and supply and distribution services to ensure successful delivery of the kits to MGB's patients.
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From Liability To Asset: A TMF Rescue
The company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. During NDA preparations, they discovered that the Trial Master File for these studies was scattered across hundreds of boxes of paper and several hard drives. The document experts at Phlexglobal quickly scoped the project and were convinced they could deliver an inspection-ready TMF in the time allowed – which was fast running out.
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Development Of Qualified Cold Chain Solution For Vaccine Transport To Uganda
Maintaining the cold chain is a challenge when handling biologics such as vaccines, particularly when the clinic is in a remote location. Learn more about how Fisher Bioservices developed a qualified cold chain solution to transport Ebola vaccines to Uganda.
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Comparing Continuous And Batch Processing In Downstream Purification
Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.
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The Michael J. Fox Foundation For Parkinson’s Research Works With Service Provider To Remove Reimbursement And Travel Obstacles For Clinical Study Participants
In 2010, MJFF launched a large-scale clinical study conducted at a network of clinical sites around the world focused on identifying and validating Parkinson’s disease biomarkers. The study realized it needed a new way to ensure that participants were remaining engaged throughout the long protocol and that the experience was as seamless as possible for both the volunteers and the site coordinators. They were able to source a solution to support patient-centricity, as well as study site efficiency.
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.