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Trial management is at the heart of our services. Since the mid 1980's, Premier Research has organized and managed trials for numerous drugs, devices and diagnostics with studies ranging in size from a single-site trial with 15 patients to a global registry with more than 50,000 patients.
Proactive Project Management
Premier Research is an organization that selects appropriately-experienced research professionals who are capable of managing even the most complex clinical research studies to a successful conclusion. Premier Research offers therapeutically focused teams of clinical experts with the depth of knowledge and experience necessary to effectively manage any situation that may arise throughout your clinical trial. Our teams are proactively managed by our Project Managers who provide oversight on all functions in a study, working to keep each project on target to meet each sponsor’s exacting needs. Our approach is firmly grounded in comprehensive Project Management and well-defined processes. Premier Research recognizes that comprehensive Project Management is the key to the success of any study.
Strong Site Relationships
To achieve enrollment targets within required timelines, Premier Research understands the importance of selecting the right investigative sites. Premier Research has developed and maintains an Investigator Network that encompasses all major therapeutic areas with more than 5,000 investigative sites. Furthermore, the recruitment of investigators involves our well-defined process for site selection through the use of comprehensive study-specific questionnaires, feasibility assessments and expert evaluation of the potential sites to ensure a high probability of success for each study.
Experienced, Well Trained Monitors
Our project teams work in close collaboration with our sponsors and stay in close contact with the investigator sites through regular communication and monitoring. We employ regionally-based, highly experienced CRAs who are fully conversant in English and their local language and understand how to support each investigator to maximize quality and performance. The Premier Research CRA team participates in a rigorous, comprehensive training program and works with the expectation that they will seamlessly integrate into the site study team. It is their goal to demonstrate to the sites that they are an extension of their team and can be relied upon for the full support necessary to effectively manage any study. Equally important is their familiarity with local ethics and regulatory requirements – knowledge which is invaluable in reducing approval process timelines.
Enhanced Communication
We provide detailed communication, from kick-off meetings to weekly teleconferences to tracking of each study to ensure that our sponsors are always fully up-to-date with their study progress. Our trial management systems include robust tools that provide full functionality to support the day-to-day process of trial delivery. These systems serve as central repositories for all study communications and allow the project team to generate metrics reports that provide comprehensive study status information. Our systems are used to track investigator information and contracting details, essential documents, monitoring visits, report status, correspondence with the sites, protocol violations and other pertinent study information.
Services- Project Management
- Protocol Development
- Feasibility
- Site Identification and Selection
- Site Qualification
- Investigator Contract Negotiation
- Regulatory Document Management
- IRB Submission
- Investigator Meeting Preparation
- Site Initiation
- Clinical Monitoring
- Site Management
- Patient Recruitment Support
- Investigator Grant Management
- Trial Master File Management
- Vendor Management
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