INSIGHTS ON CLINICAL TRIAL DESIGN

• The Story Behind MIDBA: An Exclusive Interview

  A new regulatory framework reduces PK bridging study needs, helping sponsors streamline device transitions, lower costs, speed up timelines, and boost regulatory predictability for combination products.

• Clinical Trial Recruitment Strategies For Rare Disease Studies

  By deploying mobile clinics equipped with specialized diagnostic tools and trained technicians, sponsors can execute protocol-adherent assessments right in the participant's community.

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• Why You Should Include SDOH In Clinical Trial Recruitment

  Embrace a broader approach to diversity in clinical trials by addressing social determinants of health and designing inclusive studies that ensure equitable representation and access to all patients.

• Why Site Engagement Belongs At Investigators' Meetings

  8/4/2026

  Investigators’ meetings are a great opportunity to give sites direct access to the teams supporting patient travel and reimbursement, clarify available services early, and surface practical needs before they become study barriers.

• Critical Imaging Risks In GLP-1 And Neurology Studies

  4/3/2025

  In the evolving landscape of GLP-1 and neurology clinical trials, imaging has become a pivotal tool for evaluating both efficacy and safety. Delve into the early indicators of imaging-related challenges and insights into preclinical strategies for effective risk mitigation.

• Virtual eConsent For Decentralized Trials

  12/23/2025

  Virtual eConsent improves accessibility and compliance in decentralized trials, streamlining enrollment with a secure, user-friendly process for informed consent in remote research.

• Improving Patient Access Through Home-Based Trials, Site Networks

  10/23/2024

  By implementing home trial support, sponsors can improve patient access, enhance diversity, and ultimately accelerate the development of new therapies.

• Early Immune Profiling With In Vivo, In Vitro, And Ex Vivo Systems

  10/7/2025

  Modern biologics increasingly interact with the immune system. While these innovations enable transformative therapies, they can also provoke acute immune activation during first-in-human (FIH) trials.