FEATURED ARTICLES

• 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.

• Your Strategy For Patient-Forward Rare Disease Research

  Collectively, rare diseases make up the most challenging area in clinical research. Individually, they present unique hurdles for pharmaceutical companies and CROs. Our eBook explains how to develop creative strategies to plan and operationalize rare disease programs that put the patient first. And second. And third.

• ALS Studies And Lessons Learned From COVID-19

  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.

• BioPharma Market Launch In The Age of COVID-19

  The COVID-19 pandemic (C19) has complicated the transformation most life-sciences companies – generally irrespective of size and development status – have been undergoing for the past few years. It has definitely affected the pace and methods used to achieve both clinical and commercial development success. Moreover, it has trained a bright light on the reasons that CEOs have been striving to transform their organizations. This paper will look at lessons learned from a wide range of interactions with pharmaceutical companies during this dynamic period. C19 has altered the landscape of options when it comes to addressing many of these challenges, and this paper will explore how CEOs might respond in their own novel ways.

• External Controls (Part II): Informed Choices Amidst A Portfolio Of Options

  Regulatory concepts referable to the creation of an external control group have long been noted and occasionally implemented, particularly for diseases with severe morbidity, mortality, and unmet medical need. This white paper outlines the potential benefits and disadvantages of using an external control within a program and the key criteria from representative programs that have successfully passed industry and regulatory muster to use external controls in registrational programs.

• Strategic Considerations For Regulatory, Operational, And Commercial Success In Dementia Research

  Given the burden that caring for individuals with dementia places on both the health care system and caregivers, research and development efforts now extend beyond Alzheimer’s disease to explore a mosaic of syndromes, each of which presents unique and significant challenges, in part because so much remains unknown about the pathophysiology, clinical presentation, and course of these conditions.

• Proactive Strategies For Meeting NDA Timelines Despite Last Minute Supplemental Study Requests

  With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug.  Having a CRO that is experienced in the common FDA-required studies for NDA submission can make or break the submission timeline. Nimble responses and expert logistics setups can make all the difference.

• Reinventing Neurodegenerative Protocols To Overcome COVID-19 Hurdles

  A global, pivotal Phase III Alzheimer’s trial aiming to screen 6,000+ patients faced unforeseen challenges when the COVID-19 pandemic hit just a few months into recruitment. Finding a solution that provided proactive screening, assessment, and IP administration techniques enabled a new approach to collecting patient data and administering required IP and study visits which preserved the study integrity.

• Developing Gene-Based Therapeutics

  The regulatory, operational, and commercial forces that impact gene therapy development continue to evolve dramatically – not just in the US but throughout the world. This paper explores strategic considerations for regulatory, operational, and commercial success.

• How COVID-19 Is Transforming Perceptions And Approaches To Clinical Research

  The COVID-19 pandemic has forever changed our perceptions of clinical research—but how has it changed them? That was the underlying question in a recent two-part survey of C-Suite executives. By taking a deeper look into what fuels these attitude shifts, we were able to gain a clearer picture of how COVID-19 may transform the industry.

• 5 Ways To Adapt Your Neurodegenerative Disease Trial To The World Of COVID-19

  When COVID-19 exploded around the world, in-progress neurodegenerative disease trials – as well as studies preparing to launch – were faced with a sudden and unexpected challenge: how to adapt their approach with the least disruption possible. This ebook provides practical tips for adjusting study operations to overcome unforeseen disruptions.

• Pharmacy Services In A Phase I Clinical Research Unit

  This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.

• Ensuring Access And Approval For Innovative Therapies In Scleroderma

  Clinical research and development programs for innovative therapies in scleroderma must accommodate the diverse data needs of multiple stakeholders. This white paper explores the requirements to create an integrated program capable of demonstrating the “value” of a new product, as well as clinical utility and therapeutic novelty.

• An Excerpt from CRO Quality Benchmarking - Phase II-III Service Providers, 12th Edition

  Which provider is best to conduct a given trial? Who will perform the best? This report includes insights from 233 experienced Phase II/III outsourcers and nearly 700 service provider encounters – all helping to frame what you need to be in the driver’s seat.

• An Excerpt From CRO Quality Benchmarking - Phase I Service Providers, 12th Edition

  Which provider is best to conduct a given trial? Who will perform the best? This report includes insights from 190 experienced Phase I outsourcers and more than 600 service provider encounters – all helping to frame what you need to be in the driver’s seat.

• COVID-19 Clinical Trials: A Guidebook For Trial Design And Study Conduct

  The COVID-19 pandemic has challenged the research world to think differently about the conduct of global clinical trials. This guidebook aims to provide other research organizations and related entities with valuable insight into effective study planning and execution in these extraordinary times.

• Rescue Studies: 5 Ways To Turn Clinical Trial Distress Into Success

  With such a high risk of failure and so much already invested in your compound, it’s important to recognize areas in your ongoing study that may need realignment. How do you turn an at-risk study into a successful clinical trial? We have identified five areas where your study needs attention, and possibly intervention.

• 7 Trends In Early Phase Clinical Trials

  You have a lot at stake in your early phase trial, and the perpetual movement of science and regulation adds extra levels of risk. But, by applying a strategic approach to innovation, you can discern and leverage the necessary and beneficial shifts in early phase trial practice to drive your success. As we discuss these emerging trends, we hope to identify new opportunities for sponsors to extend their successes beyond Phase I and optimize potential for success all the way through to market approval.

• 6 Reasons Early Phase Oncology Trials Fail

  Only 15% of oncology drugs that get started in clinical trials reach phase III studies, and the likelihood of approval (LOA) for any new anticancer drug entering clinical trials is just over 5%. Learn the pitfalls that drive early-phase trials to failure and tips to prevent your own trial from floundering.

• 4 Real-World Evidence Trends

  Preparing For Real-World Evidence? This eBook unlocks four trends to consider before you take the first step.