Our integrated, cross-functional team approach and custom solutions move your product forward as efficiently as possible. Using proven Premier Consulting clinical methodologies combined with our deep expertise and knowledge, we meet all applicable U.S. Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulatory requirements. With access to Premier Research’s end-to-end clinical research and development capabilities, Premier Consulting can help you execute regulatory-compliant clinical trials while reducing overall study costs.
Clinical Design Strategy and Protocol Development
Our experts will develop a customized clinical program for your products.
- Drug-drug interactions
- Special populations (renal, hepatics, elderly)
- Crossover designs
- Drug metabolism
- Safety and efficacy
- Placebo-controlled studies
- Non-inferiority/superiority studies
- Quality of life
Clinical Study Execution
- Bioanalytical, clinical lab and clinical site selection, and contract negotiation
- Clinical trials management
- Data management
- Medical writing
- Project management
Our knowledgeable pharmacokineticists (PK)/pharmacodynamicists (PD) work diligently to determine the proper PK study designs needed to support a successful clinical drug development plan, while avoiding unnecessary and costly studies.
Our expertise includes Phase I PK data analyses—both compartmental and non-compartmental—and interspecies scaling for first-time studies in humans. Additionally, our PK staff has highly specialized competency in the bioequivalence study process. By applying this PK and biopharmaceutics proficiency, we’re able to design and manage bioequivalence and clinical endpoint studies, as well as analyze and report data and results in International Conference on Harmonisation (ICH) format—a process that has resulted in numerous regulatory approvals for our clients.
We provide expert strategic PK/PD modeling and simulation services, including but not limited to:
- Dose selection
- Understanding translational and system pharmacology
- Quantitative due diligence assessment
- Strategic design of PK/PD, Population PK or Sparse Sampling studies in humans and animals
- Pharmacokinetic data analysis (compartmental and population analyses)
- PK/PD modeling and simulation
- Interspecies scaling
- Bioequivalence study design and data analysis
- Bioequivalence risk assessment
- Trial design evaluation, optimization and data analysis
- Preparation and submission of the human clinical trials sections of the NDA regulatory application