GUEST COLUMNISTS

• 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. 

• 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.

CLINICAL TRIAL WHITE PAPERS

• Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

  Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

• 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.

• Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S.

  The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.

• The Complete Guide To eRegulatory And eSource For Clinical Trial Sites

  Shifting to eRegulatory and eSource workflows is a requirement for clinical trial sites to continue to scale and grow their studies. However, many site leaders are not fully prepared for the transition. This guide is designed as an in-depth overview of how eRegulatory and eSource are impacting clinical trials, and the steps you can take to prepare now.

• Challenges And Opportunities In Clinical Data Management

  Breakthrough medical interventions are nothing without accurate, comprehensive clinical trial data. Unfortunately, in today’s high-pressured, fast-paced clinical development environment a huge challenge exists with the cleanliness, completeness and quality of clinical trial data. This recent survey of professionals involved in clinical data management at large pharma companies, biotechs, device developers and CROs based around the world provided valuable insight.

• Addressing Cultural Fit With Outsourced Resources: How Can You Find The Right Match?

  In order to make any outsourcing model work effectively, it is essential to evaluate and match both the skill set and the cultural fit of the candidate and sponsor. This article will discuss strategies for finding the best cultural match and the impact it can have on implementing a successful FSP model.