GUEST COLUMNISTS

• How A Small Biotech Survived A Virtual Regulatory Inspection During COVID-19

  For a small U.S. biotech company, a Japanese Health Authority (MHLW/PMDA) on-site inspection scheduled in March 2020 would be the first of multiple global regulatory pre-approval inspections of its novel product for treatment of a rare disease. Then COVID-19 happened.

• Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations

  In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.

• Healing From A Pandemic And Building Resilience Into Future Clinical Trials

  We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.

• How Trial Sites & Sponsors Can Deliver On Patient Convenience In The Age Of COVID-19

  For insights on the impact of COVID-19 on patient convenience in clinical studies, and how sites and sponsors should respond, Clinical Leader reached out to Allyson Small, chief operating officer of the Society for Clinical Research Sites (SCRS) and a nearly 20-year-veteran of the healthcare industry.

• 6 Practical Ways To Increase Diversity In Clinical Trials

  Even when a certain disease is more prevalent in a particular minority population, it can still be difficult for trial investigators to reach the right individuals. As an industry — as a group of researchers dedicating our lives to improve the health of others, regardless of their race, age, gender, or disease — how can we do better?

• 5 Common Challenges In Genetics-Based Clinical Trials — And How To Overcome Them

  Before embarking on a genetics-based clinical trial, pharmaceutical companies should fully appreciate the unique challenges genetic information presents and implement strategies to navigate potential pitfalls. Otherwise, trial progress may slow or stall, resulting in costly study delays or even trial failures.

• The Expanding Role Of Artificial Intelligence In Clinical Research

  While protocols and standards in clinical research have become increasingly complex, slowing progress and increasing costs, companies from startups to Big Pharma are identifying opportunities to apply AI to enhance trial efficiency, patient enrollment, and outcomes targeting.

• Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19

  Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.

CLINICAL TRIAL WHITE PAPERS

• Looking Ahead To 2019: Insights Into Clinical Research Trends from Our Experts

  IN 2018 there were many changes, trends, regulations and priorities that shaped the direction of the clinical research and drug development fields. In this paper, WCG experts share what they anticipate in 2019, and what everyone should be prepared for as we approach another year of change.

• Trial Results Summaries: Improving Patient Communications

  This paper discusses the challenges inherent in the current practices of providing trial results summaries to trial participants. It presents an alternative approach to distributing trial results summaries that takes advantage of commonly used technologies to more quickly, efficiently and reliably provide trial results summaries to trial participants. The benefits of this approach to clinical trial sponsors, patients, and their relationship with each other are also discussed.

• Addressing Suggestibility As A Psychological Phenomenon In Clinical Trials

  How can researchers identify participants’ overall level of suggestibility and then focus on the minimization of this characteristic to solve the issue of suggestibility in clinical trial?

• Spotlight On Quality In Study Startup

  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.

• 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.

• Mitigating Inherent Risks In Global Sample Processing

  The global demand for specialized sample processing has grown dramatically however despite the rising need, research teams continue to struggle to obtain high-quality laboratory support services to perform sample processing. Learn how innovative flow cytometry fast turnaround and monitored, specialized processing can help safeguard samples.