GUEST COLUMNISTS

• 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. 

• 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. 

• 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.

• 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.

• 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.

• 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

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.