INSIGHTS ON CLINICAL TRIAL DESIGN

• Critical Inputs For Configuring An RTSM

  Uncover why clearly defined visit schedules and dispensing events are essential in RTSM design — and how resolving protocol ambiguity early prevents downstream complexity across systems and sites.

• Strategic Implications Of The Single Phase 3 Approval Paradigm

  As FDA single-trial approvals gain traction, CNS developers need stronger early evidence. Learn how biomarkers, patient selection, and regulatory strategy can accelerate development.

• Everything You Need To Know About Mobile Visits And Community Sites

  Discover how decentralized clinical trials (DCTs) and mobile visits contribute to more diverse, efficient, and patient-centric research, ultimately enhancing trial outcomes and data quality.

• How To Reduce Patient Dropout Rates In Clinical Trials

  Sponsors are addressing patient dropout rates by shifting from reactive troubleshooting to proactive protocol designs that minimize participant burden.

• Stop Guessing On Trial Feasibility: Simulating Patient Recruitment With AI

  5/28/2026

  Simulate enrollment, endpoints, and criteria with integrated data and synthetic populations to test protocol feasibility early — refining design and reducing recruitment and regulatory risks.

• RTSM Misalignment Hiding In Your Clinical Trial Protocol

  5/13/2026

  Unclear protocol details can quickly create problems across a clinical trial, but bringing in experienced systems thinkers early to identify gaps before they create downstream issues can help.

• Measuring What Can't Be Seen: How PTSD Clinical Trials Prove A Drug Works

  5/22/2026

  PTSD trials expose one of the hardest problems in modern drug development, a reliance on clinician-administered and patient-reported scales to determine whether a therapy truly works.

• Why Operational Design Determines Recruitment And Retention

  4/22/2026

  Patient recruitment challenges often receive the most attention in clinical trials, yet many enrollment and retention issues stem from operational friction embedded in study design.

• Patient Trust And Engagement In The Age Of Decentralized Trials

  4/10/2025

  To truly maximize enrollment in decentralized models, sponsors must invest in human connection to build the trust needed to move patients from awareness to active participation.