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

• Fusing Specifications And Design For Data Collection Casebooks With Veeva Vault EDC

  Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.

• Virtual Approaches In Oncology Clinical Trials During COVID-19 And Onward

  Patients living with cancer are among the most vulnerable during the pandemic, but sponsors and researchers understand oncology drug development must continue. This paper will discuss how COVID-19 is driving change in the oncology trial landscape and how these insights may shape the future of post-pandemic clinical development. Given the unique concerns of cancer patients, the scope of the discussion will focus on outlining innovative and flexible tech-enabled approaches and operational adjustments that can improve the patient experience.

• Commercialization Accelerator For Emerging Companies

  For any life sciences company bringing its first product to market, the “commercialization to-do list” is long and punctuated by one critical strategic decision after another. This guide explores lessons learned from industry leaders facing the challenges of building commercial operations capabilities and how they avoid pitfalls.

• 10 Tips For Writing Compliant Clinical Trial Participant Materials

  Recruitment materials are a potential participant’s first introduction to the study, and post-consent materials can influence an individual’s decision about continued participation. It is important to adhere to the principles of participant protection, allowing participants to make informed decisions about what is in their own best interest, with the materials that appear at the earliest stages of recruitment as well as through the life of the study. Well-informed prospective and current participants lead to improved recruitment and retention rates.

• Vital Tools For Centralized Statistical Monitoring Of eCOA/ePRO Data

  As the industry moves to adopt patient-centric approaches to clinical trials, there is an opportunity to adopt the best practices of QbD and risk-based methodologies to ensure that patient reported data are effectively being monitored. In this paper, we discuss the value of using advanced technology — specifically Centralized Statistical Monitoring technology - to oversee subject safety and data quality/integrity in a risk-based manner.

• Removing Barriers: Reimbursement And Compensation For Participation In Oncology Clinical Trials

  Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question. Read this white paper to learn the impact that participant payments may play on clinical trial recruitment.