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. Patient-Centric Trials: Overcome Enrollment Challenges By Putting Patients First 6/11/2019

    Just as patients have a stronger voice in today’s healthcare marketplace, that voice should resonate earlier in the drug development process. By adopting a patient-centric approach during protocol design and in day-to-day study management, sponsors can expect improved patient enrollment and retention, as well as a cleaner study with definitive outcomes.

19. Making The Most Of Clinical Trial Data 5/22/2019

    To control costs, improve efficiency, and successfully bring more drugs to market—life-changing, life-saving drugs—pharma and biopharma companies need to follow the lead of the financial industry and forward-thinking health systems. Here, we discuss how a data-driven approach to clinical trials—from patient recruitment to post-regulatory approval—can put an end to missed deadlines, failed studies, and wasted time and money.

20. Advanced Analytics For The Monitoring Of Clinical Trials 4/26/2019

    Clinical research generates a massive amount of data. Unfortunately, because of the way most clinical data programs currently work, much of these data are not used to their fullest extent; they are simply filed away. This white paper will focus on the benefits provided by a unique and advanced analytical approach to study monitoring beyond the minimum necessary RBM approach.