Risk-based quality management (RBQM) continues to gain traction across clinical development, yet adoption remains uneven and many organizations still struggle to realize its full value. In practice, the challenge is often not whether RBQM components are being used, but whether...
Expertise: Clinical Development 117 results
Clinical Development
Siân Ratcliffe Smethurst, Ph.D.
Clinical Development
Strengthening Clinical Trial Site Relationships: Defining Sponsor and CRO Roles
Site partnerships influence every aspect of a clinical trial. Sites manage patients and data across a demanding portfolio of studies, while their interactions with sponsors and CROs can shape the efficiency and quality of a study. When responsibilities are clearly...
Clinical Development
Driving Innovation in Clinical Development
Clinical trials are more complex than ever. Our team delivers foresight and agility to help accelerate approvals.
Clinical Development
End-to-End Solutions That Power Clinical Success
Streamline and accelerate development with our integrated clinical, consulting, and technology services.
As drug development becomes increasingly complex, Model-Informed Drug Development (MIDD) has emerged as a critical strategy for optimizing clinical trial design, enhancing regulatory engagement, and accelerating development timelines. While population pharmacokinetic/pharmacodynamic (PopPK/PD) modeling is a central component of MIDD, sponsors...
Clinical Development
Just-In-Time Safety Solutions for Phase I Trials
In Phase I trials, especially those with healthy volunteers, safety monitoring is often minimal due to the lower risk of adverse events. However, trials are unpredictable. To mitigate risk, Premier Research offers a just-in-time (JIT) safety database, an agile, budget-friendly...
Clinical Development
What Can a Corn Analogy Teach Us About Smarter Trial Oversight?
In an industry that has historically relied on manual oversight methods, clinical trial monitoring is evolving—but not rapidly. Over the past several decades, the implementation of technology and risk-based monitoring (RBM) strategies has become essential for ensuring both data integrity...
Clinical Development
Beyond the Hype: Innovating Obesity Treatments for Real-World Impact
Clinical Development