Nicholas Jacobus

CRIO’s chief innovation officer, Mike Wenger touches on the two ways sites get AI adoption wrong.

CRIO’s Mike Wenger, speaker at this year's SCRS summit, maps how sites are actually deploying AI post-pilot stage.

Paradigm’s Kurt Mussina discusses why scale should drive operational efficiency, not consolidation into single-site studies.

Paradigm’s Kurt Mussina touches on why he rejects the “site management organization” model in favor of one unified business.

ProofPilot’s Lauren Briggs talks on why sponsors and CROs fail at tech rollouts by skipping change management, and pushes for the industry to judge trial technology by real workflow impact rather than feature checklists.

ProofPilot’s Lauren Briggs touches on why site tech adoption hinges on the first 90 days after rollout, and why tools succeed only when they remove work from a site’s plate rather than adding another login to juggle.

Jennifer Byrne, CEO, Javara touches on why fixing clinical research requires sustained infrastructure investment and workforce development.

Sequoia’s Dan White and Dr. Tom Kreamer touch on why sponsors and CROs should treat a site network as one centralized partnerto speed startup timelines and strengthen execution.

Sequoia Clinical Research’s CEO Dan White and CMO, Dr. Tom Kreamer explain what it takes to merge three site organizations into one network.

Javara CEO Jennifer Byrne talks about the requirements for embedding clinical trials directly into physician practices and why solving the “last mile” of trial participation means building infrastructure at the actual point of care.

Trially CEO Kyle McAllister explains why transparent AI reasoning is essential for trial patient matching.

Trially Co-founder and CEO Kyle McAllister, explains how AI absorbing the bulk of clinical-trial chart reviews can free research sites to focus staff time on higher-value tasks.

Incyte reports sustained 24-week efficacy and consistent safety data for Opzelura cream in moderate atopic dermatitis, supporting growing interest in nonsteroidal topical therapies for long-term disease control.

Zentails announced the first dosage of Azenosertib administered in its phase III Aspenova trial to test azenosertib vs chemotherapy in Cyclin E1-positive platinum-resistant ovarian cancer.

FDA clears Cellenkos’ IND for CK0802, enabling a mid-stage trial in steroid-refractory GVHD.

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

The company submitted the new dosage for approval based on its Phase III trial results.

Examine strategies for validating, monitoring, and safely deploying configurable AI agents to ensure compliance and performance in clinical trials.

Take a closer look at how agentic AI can automate repetitive monitoring tasks while keeping human oversight central to critical decision-making in clinical research.

Gain perspective on how agentic AI can bridge eCOA, EDC, IRT, and CTMS platforms to reduce manual effort and improve operational efficiency.

Understand how adaptive human-in-the-loop frameworks can maintain safety and decision quality as AI becomes more embedded in trial monitoring and data review.

Gain insight into how AI-powered agents can eliminate inefficiencies, shorten development timelines, and free clinical teams to focus on strategic decision-making.

FDA outlines its limited operations during the funding lapse, focusing on essential public health activities while halting new drug applications.