Clinical Operations

Managing & delivering every study with your business priorities in mind.

Getting from concept to approval takes exceptional trial execution

Overview

Whether it’s a small-scale pain study or an ultra-rare disease trial spanning the world, we follow a proven roadmap for planning and execution: Start with a clear objective, select and guide the best team, observe every detail, communicate relentlessly, and execute to the highest standards.

Therapeutic leadership, optimized teams

Once we’ve effectively designed your trial, we build the optimal team to deliver it. Your study will be led by a therapeutically-aligned project manager with access to resources and subject matter experts around the globe. Every project team receives the full support of an operational strategist and senior leaders.

A focus on milestones and patient engagement

Our Clinical Operations team is intensely patient- and customer-focused. Our first commitment is to enroll—and retain—the right patients. Patients are key to gathering data and meeting your study milestones. Our Clinical Operations professionals focus on finding ways to keep patients engaged, in part by ensuring sites are engaged. Early in our planning process we align on patient recruitment plans and site communication strategies. Then we execute them, all while closely monitoring site activity to address recruitment challenges where we need to.

Monitoring for quality

We deliver quality data. We prioritize centralized monitoring strategies, leveraging our proprietary Remarque technology, which aggregates data to streamline the management of various Risk-Based Quality Management (RBQM) aspects in clinical trials. Our CRAs regularly visit sites in more than 70 countries and work in tandem with in-house CRAs.

These efforts are further supported through collaboration with biostatistics and data management to ensure heightened efficiency, accuracy, and patient safety.

resources

Stay ahead of the curve by browsing our extensive library of white papers, case studies, blog posts, and more.

Ready to get started? So are we.

Drop us a line to learn more about how we can help.