Featured Articles

11. Managing Alzheimer's Trials In A Diverse Global Environment 7/22/2021

    Diagnostics and treatment for Alzheimer’s Disease vary – both around the world and around the block. In this article, read how recognizing the common disparities for these clinical trials, ranging from standards of care to lack of diversity, brings sponsors and other stakeholders closer to maintaining standardized protocols for Alzheimer’s studies.

12. Pros And Cons: Defining Site Expertise Across Veteran And Research-Naïve Sites 7/2/2021

    Clinical sites that have a great deal of experience are generally sought after, but can often be busy running other trials. It may be beneficial to consider less experienced sites in order to have more trial options. But of course, there are some necessary considerations when turning to these sites.

13. Blood Disorder Clinical Trials – Adapting To COVID-19 Challenges 7/2/2021

    The spread of COVID-19 has heightened the potential risk of infection for patients suffering from blood disorders. Hematologist Dr. Robert S. Negrin, a new member of Biorasi’s growing Scientific Advisory Board, weighs in on understanding and adapting to changes to blood disorder trials and treatment during the pandemic.

14. Spotlight On PNH: The Evolution Of Research And Treatment 6/15/2021

    Paroxysmal nocturnal hemoglobinuria (PNH) is defined as an acquired rare disease triggered by a rare mutation in bone marrow stem cells, with patients experiencing production of irregular blood cells. In terms of clinical studies, PNH’s uniqueness presents a number of operational challenges. In this article, Dr. Mehool Patel discusses innovations in the treatment of PNH, the diverse nature of this rare disease, as well as solutions for PNH clinical trial enrollment and availability.

15. Delivering On Rare Disease Trial Milestones During The COVID-19 Crisis 6/15/2021

    At the start of the COVID-19 crisis a sponsors was facing delays in an ongoing basket trial for rare nephropathies, specifically the completion of two critical project milestones. With a impact mitigation strategy in place, Biorasi was able to meet both data delivery deadlines – keeping the trial on track and completing the first part of the study despite operational challenges caused by the COVID-19 crisis.

16. Addressing Common Challenges In Rare Disease 6/15/2021

    Although each rare disease is unique, many challenges to the clinical operations required for successful rare disease trials are consistent across indications. Learn more about these common challenges expected during the course of researching rare diseases that must be addressed before progressing to clinical trials.

17. Optimizing Rare Disease Trials From An Operational Point Of View 6/15/2021

    The operational strategy for rare disease trials is markedly more complex than those for traditional pharmaceuticals. The standard responsibilities of maintaining clinical trial protocols, short and long-term schedules and milestones, and project budgets are just a small part of the burden represented by each unique rare disease and its accompanying trial. This white paper explains a three-tiered strategy to allow pharmaceutical companies, sponsors, CROs, and patients to each better their own ROI in the end result.

18. The Rise Of Risk-Based Monitoring In The Clinical Trial Landscape 5/25/2021

    Risk Based Monitoring (RBM) is beginning to feature prominently as the go-to monitoring solution for clinical trials, combining the best of existing monitoring methods with the flexibility needed to keep studies on track.

19. Unflattening The Curve: Minimize The Impact To Patients Who Depend On Your Successful Clinical Trial 4/21/2021

    Similar to how the response and immediate action to the “Flattening the Curve” movement in 2020 was executed to dramatically lessen the severity and impact of the pandemic on millions of lives, the actions and strategies implemented in today’s clinical studies will impact how patients in current trials will get their investigational treatments. Without a proactive and comprehensive strategy in place to manage clinical trials during the pandemic, consequences may be severe –especially for those that need the treatment the most.

20. Keep It Simple: The Top 5 Steps For Successful Protocol Design 4/21/2021

    Starting clinical trials in the right direction begins with a well-designed study protocol – the more comprehensive, the better. In this article we discuss some of the more “common sense” best practices to consider during the protocol design process with Dr. Robert Wilkins, former PI and Founder of QPS Consulting.