The Critical Role of Clinical Ops Teams in Maintaining Clinical Trial Integrity
August 15th 2025Ron Lanton, partner, Lanton Law, explains why evolving federal guidance and new technologies are pushing clinical operations teams to strengthen oversight and safeguard the credibility of clinical research.
What the Future Holds for Clinical Trials as AI and Digital Twins Become More Embedded
August 14th 2025Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI and digital twins are helping clinical trials become more efficient, patient-centric, and capable of supporting innovative study designs over the next decade.
Enhancing Clinical Trial Integrity Through AI and Digital Twin Technologies
August 13th 2025Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI and digital twin technologies are being applied to improve data transparency, ensure reproducibility, and strengthen the reliability of clinical trial outcomes.
Genmab’s Epkinly Shows Major Survival Benefit in Relapsed, Refractory Follicular Lymphoma
August 8th 2025Results from the Phase III EPCORE FL-1 trial (NCT05409066) showed that patients treated with Epkinly (epcoritamab) in combination with Rituxan (rituximab) and Revlimid (lenalidomide) for relapsed or refractory follicular lymphoma demonstrated significant improvements in overall response rate and progression-free survival.
Using Digital Twins to Improve Efficiency and Accuracy in Clinical Research
August 6th 2025Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI-designed therapies and digital twin technology are accelerating clinical trials, improving data precision, and reshaping early-phase drug development.
FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma
July 22nd 2025The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.