In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), discusses the challenges of achieving true operational flexibility in clinical ...

The FDA has awarded Breakthrough Therapy Designation to izalontamab brengitecan, a potential first-in-class bispecific ...

Ron Lanton, partner, Lanton Law, explains how shifts in policy and government guidance could reduce public participation and complicate the design and recruitment of future vaccine trials.

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed articles of the week—featuring updated ...

Applied Clinical Trials is the thought leader in pharmaceutical drug development operations and clinical trial design, management, and monitoring.

Rachel Smith Executive Director Rare Disease Center of Excellence Parexel International Ms. Smith brings more than a decade of experience in every development phase of rare disease and cell and gene ...

Dr. Mwango Kashoki, MD, MPH Senior Vice President Global Head of Regulatory Strategy Parexel International Dr. Kashoki has 16 years of drug review, development, and regulatory experience at the FDA.

In the Phase II STARLIGHT trial, MCO-010 gene therapy improved visual acuity in Stargardt disease patients, with some achieving early and sustained gains and no serious adverse events, paving the way ...

The trial’s first patient has been treated to assess the BREATHE Airway Scaffold, which was developed to enhance breathing and daily functioning in patients with severe emphysema.

A 2025 survey highlights growing momentum for multi-indication drug development, with opportunities in innovative trial ...

Ron 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 ...

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, shares practical ways clinical teams can strengthen trial ...