FEATURED ARTICLES

• 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.

• Innovative Recruitment And Retention Strategies For Phase III Rare Cardiovascular Disease Study

  A Phase III, placebo-controlled, double blind, randomized clinical study of pulsed inhaled nitric oxide targeting rare cardiovascular disease was facing challenges. A partnership helped them solve their issues with patient recruitment, organizational effectiveness and regional patient expertise.

• 10 Tips For Pitching To Life Science Investors

  Straight from the mouths of successful entrepreneurs, these 10 tips can make securing funding for your drug development program a success.

• A Multiple Sclerosis Clinical Trial Collaboration

  Managing multiple outcome measures and rapid patient recruitment for Phase IIB clinical trial on targeting relapse-remitting Multiple Sclerosis

• 10 Steps To Better Alzheimer’s Disease Research

  To date, advances in improving the lives of patients suffering from the ravages of Alzheimer's Disease (AD) and related dementias have been hard won, but research is at a tipping point. This CRO shares their 40 years of knowledge in Alzheimer's Disease research with steps on how to improve processes.

• Early Phase Programs And Development To An Inflection Point

  Master protocols are created with hypothesis generation intentions to serve as a method to evaluate product utility across a portfolio of indications in an organized and efficient manner. Herein, this article provides an overview of master protocols with a focus on variations within basket designs, which may be useful for exploratory and hypothesis generating purpose.

• Prepping For Success: Five Operational Considerations For Rare Disease Programs

  Despite my extensive operational expertise and experience, nothing could prepare me for the complexity of my first rare disease program, studying spinal muscular atrophy (SMA) in young pediatric populations. And, all my previous expertise notwithstanding, I came away from the SMA study with five new learnings for managing a rare disease study.

• Optimizing Site And Patient Engagement In Rescue Studies

  A Phase II oncology study run by a large CRO struggled with slow patient recruitment, poor site engagement, and data entry delays. A partnership allowed them to engage sites to dramatically boost recruitment and improve data entry, allowing the sponsor to hit recruitment targets and database lock on schedule.

• Modern Oncology Research Landscape: Staying Ahead Of The Game

  Companies that can position themselves strategically during preclinical explorations and throughout the development process can bolster their chances of achieving approval and market success. To do so, they must understand key elements of the “new” oncology research landscape.