GUEST COLUMNISTS

• Is Your Site Selection Process Optimized?

  Our current approaches for assessing potential sites is not keeping pace with the increase in trial complexity observed across the industry. By adjusting our strategy during this critical state of a trial, we take a step toward improving overall clinical trial performance and ultimately advancing treatments more quickly and efficiently.

• How To Navigate Compliance With FDA’s 21 CFR Part 11

  21 CFR Part 11, the FDA's regulation on electronic records and electronic signatures, causes sleepless nights for many quality control experts and directors of regulatory compliance at CROs and pharma companies. How can you ensure compliance with this regulation?

• FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch

  The FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. These five key elements deserve our attention.

• The 3 Secrets To Becoming an Effective Leader In Clinical Research

  Experience in clinical research provides a solid foundation, which better positions you to launch your career into management- and executive-level roles. However, you will move away from operational execution and will be called to develop the skillsets and level of confidence required to lead and guide teams. What are the 3 skillsets to understand, develop, and refine your journey?

• Incorporating The Voices Of Parents And Children In Pediatric Clinical Trials

  Pediatric trials are far more complex than simply evaluating a therapy in the context of a child’s disease or illness. They are a family affair that must accommodate the diverse needs of parents and other family members caring for those children. This article discusses recent survey findings from the Center for Information and Study on Clinical Research Participation.

• 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.

• 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.

• 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. 

CLINICAL TRIAL WHITE PAPERS

• Navigating The Changing Clinical Trial Landscape

  The only way to map a course to a better future is to understand the reality of the current landscape and what perpetuates the status quo. To do this, insight was gathered from those involved in clinical trials. The output of this research reveals the challenges and priorities that will shape the journey to the future of clinical research.

• China Embraces Decentralized Clinical Trial Solutions

  3/29/2021

  The biopharmaceutical industry in China, like the rest of the world, was forced to swiftly adopt decentralized clinical trial (DCT) approaches to maintain progress during to the COVID-19 pandemic. And, like the rest of the world, its patients, investigators and sponsors were hopeful about the benefits of using these tools. Surveys show patients, sponsors and CROs in China see the benefits of virtual and hybrid trials. Concerns remain around regulatory gaps, digital data collection and study logistics.

• Early Phase Programs And Development To An Inflection Point

  6/24/2020

  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.

• Bringing Real World Evidence Into Clinical Research

  5/15/2019

  Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.

• Spotlight On Quality In Study Startup

  6/20/2019

  This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.

• Opiod Sparing: Prescribing Less Is Insufficient

  3/31/2021

  Chronic and acute physical pain often requires treatment with strong analgesics. A treatment with opioid-sparing benefits could help mitigate the risks associated with opioids in one or more ways. This white paper analyzes how opioid-sparing benefits could help mitigate the risks associated with opioids, and argues that the opioid-sparing therapy must not diminish the level of analgesia obtained.