Distinct departments working together to facilitate efficient data flow and high-quality data.
Integration with the project team for streamlined execution
When you begin with the end in mind, you can incorporate efficiencies throughout your project development program. That’s why the Premier Research Biometrics group sets standards for each project at the outset, tailoring them to your desired outcomes and bolstering them with our scientific expertise and extensive experience.
A cross-functional team of dedicated leads from Premier Interactive Response Technology (IRT), biostatistics, and medical writing will work with you to:
- Design a protocol that represents and analyzes your outcome measures in a manner consistent with your objectives
- Plan your randomization, drug supply, and endpoint collection to assure quality, efficiency, and compliance
- Design and execute your analysis for conclusive results
- Summarize your results for clear, concise conclusions
Working with our integrated team trained in Premier’s advanced systems and capabilities, including the Premier One Ecosystem, you’ll benefit from:
- Broad and deep scientific expertise in our fields
- Collaborative interactions with our experts that set you up for success
- Comprehensive knowledge of our processes and procedures and how they work together, which means just one set of standard operating procedures (SOPs) for your clinical data
- Understanding our project implementation systems, so there’s no learning curve for dealing with a new vendor or new procedures
- Clear structure and accountability for project teams, with the Biometrics group leading the way throughout the project life cycle
Combining knowledge and experience with integrated processes to ensure improved data quality at every step, Premier’s Biometrics group makes it easier for you to focus on what matters.
- Expert scientific knowledge applied to the design of your study and its implementation
- Experience in Phase 1 to 4 trials in a broad range of therapeutic areas — with specialization in analgesia, dermatology, central nervous system disorders, and oncology
- Full service as well as standalone projects
- Management team with over 14 years of industry experience
- Staff in Europe and the U.S.
- Global systems and SOPs
Statistical considerations in the wake of COVID-19
COVID-19 has dramatically changed the way we conduct clinical trials and left many sponsors without answers when it comes to the future of their studies. Recognizing the issues is one thing, but figuring out where we go from here demands a new way of looking at some common challenges.
Advantages of ePROs
In these unprecedented times, when gathering data remotely is the method of choice, it’s worth making use of ePRO data in your clinical studies to help maintain the integrity of your clinical trials.