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Europe’s Clinical Trial Ecosystem: A Ticking Clock for Biotech Innovators?
15 October 2025
Europe’s Clinical Trial Ecosystem: A Ticking Clock for Biotech Innovators?
The European Union presents a frustrating paradox. It is a global powerhouse of scientific intellect, advanced healthcare, and pharmaceutical investment, yet it is steadily losing its footing as a leader in clinical research. For the agile, emerging biotech companies on the front lines of innovation, this isn’t just an academic observation—it’s a clear and present...
Mitigating Risks: How CROs Ensure Safe CAR-T cells Trials
14 October 2025
Mitigating Risks: How CROs Ensure Safe CAR-T cells Trials
CAR T therapy has immense potential in autoimmune diseases like multiple sclerosis, but safety remains the central concern that guides every decision. The objective is to build a development pathway that anticipates risk, manages complications promptly, and maintains therapeutic intent. Real progress depends on disciplined planning, clear decision rules, and consistent measurement that allow teams...
Are You Ready to Lead the Patient-Centric Revolution?
08 October 2025
Are You Ready to Lead the Patient-Centric Revolution?
The clinical research industry stands at an inflection point, facing a choice between two distinct futures.  The first path is “friendliness.” It’s the continuation of the status quo, softened by cosmetic improvements and well-intentioned gestures. This path accepts the underlying drivers of failure—burdensome protocols that lead to an average 30% patient dropout rate—as unavoidable costs...
Inside the Trials: Early Evidence of CAR-T cell therapy in Progressive MS
07 October 2025
Inside the Trials: Early Evidence of CAR-T cell therapy in Progressive MS
The idea of using CAR-T cell therapy for multiple sclerosis has moved from speculation to practical testing in the clinic. Early reports show that this therapeutic can be delivered safely, can reach the cerebrospinal fluid, and can produce changes in immune biomarkers that matter in progressive disease. This matters because B cells and antibody-producing cells...
Metrics That Matter: Measuring Patient Experience in Trials
01 October 2025
Metrics That Matter: Measuring Patient Experience in Trials
In business, the adage is simple: what gets measured gets managed. We apply this rigor to our financial performance and operational efficiency, so why not to our patient-centricity efforts?  For too long, the success of a clinical trial has been measured by a set of purely operational KPIs—enrollment rates, query rates, site activation times. While...
CAR-T cells vs. Anti-CD20 antibodies: Breaking Through the CNS Barrier in MS
29 September 2025
CAR-T cells vs. Anti-CD20 antibodies: Breaking Through the CNS Barrier in MS
Anti-CD20 monoclonal antibodies like ocrelizumab have advanced MS treatment significantly and offered real hope to many patients. Yet, over time, their limitations have become harder to ignore, particularly when it comes to progressive forms of MS, where patients continue to accumulate disability despite treatment.  Why Anti-CD20 Falls Short These therapies are highly effective at depleting...
Co-Created Protocols: Co-Writing the Protocol with Patients
24 September 2025
Co-Created Protocols: Co-Writing the Protocol with Patients
For decades, the clinical trial industry has asked patients for their data, their time, and their bodies. It’s time we started asking for their expertise.  True patient-centricity means shifting from passively collecting patient “input” to actively seeking patient “partnership.” This is most powerfully realized in protocol co-creation, where patients are given a seat at the...