Clinical Operations

Design, start-up and manage your trial

Our clinical operations team works with you to optimize clinical trial design, enable patient-centric approaches and guide you from first patient in, to last patient out, to database lock.

From design to trial and site management, we look for and create opportunities to innovate and improve subject recruitment and retention, and patient monitoring.

Our highly skilled team of research professionals and clinicians has a global presence in over 30 countries, driving project management and all functions for your clinical trials, taking ownership of your project to elevate the clinical development experience and advance healthcare opportunities for all.

With our global footprint, we offer full coverage for clinical monitoring services, while still maintaining flexibility and personalized service of the highest quality. Our project team structure is built for efficiency in communication and issue resolution, including hands-on and easily accessible senior leadership.

We use advanced internal systems like Clarity to view integrated data from all sources including EDC, TMF, and CTMS which enables our CRAs and CTMs to create site and patient profiles where data and performance metrics can be reviewed.

Our ongoing risk management allows our teams to identify risks to study conduct at the site level and put in place processes and tools to ease study conduct, providing superior risk oversight and management. We share our knowledge to help our clients mitigate those risks, with clear documentation of rationale for decisions and actions.

Study Start-up Essential to study start-up is meeting key milestones for regulatory submissions, including ethics, first patient enrolled (FPI), first subject in (FSI). Our team uses a set of user-friendly, easy-access intelligence tools showing all aspects of regulatory considerations based on in-depth formal and practical knowledge. Our Regulatory Green Light process focused on ICH GCP compliance is highly recognized by clients during qualification audits.

Strong site relationships are also of utmost importance, and we have proven relationships with key sites around the globe. Our investigator database accelerates site activation by making it easier to identify and determine sites most likely to qualify.

Site And Patient Support

We provide and facilitate a number of services that encourage patient and site continuation, which are critical to the successful completion of your study. From patient concierge services for logistics, lodging, and reimbursements to caretaker considerations, we make it easier for patients to participate.

Utilizing a centralized technology platform, we bring all site, patient and study team efforts together, giving site staff the tools and resources they need to stay compliant while focusing on patient care. In addition, this system provides study teams with actionable oversight of regional and global site engagement.

• Clinical trial management
• Clinical monitoring
• Project management
• Records management/TMF/eTMF
• Study start up
• Feasibility
• Patient recruitment and retention
• Site management