Clinical Guest Contributors

  1. Is Your Site Selection Process Optimized? 4/13/2021

    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.

  2. How To Navigate Compliance With FDA’s 21 CFR Part 11 4/7/2021

    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?

  3. FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch 3/19/2021

    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.

  4. The 3 Secrets To Becoming an Effective Leader In Clinical Research 3/16/2021

    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?

  5. Incorporating The Voices Of Parents And Children In Pediatric Clinical Trials 3/9/2021

    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.

  6. The Asia-Pacific Region: A Hot Spot For Clinical Trials 3/2/2021

    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.

  7. Data-Driven Insights To Improve Your Recruitment Process For Clinical Trials 2/23/2021

    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.

  8. Insource, Outsource, Or Both? Choosing The Right Model For Your Clinical Workforce 2/16/2021

    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. 

  9. Turning Point In U.S. History: Our Chance To Do Better With Clinical Trials 2/16/2021

    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. 

  10. An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials 2/2/2021

    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.