Protocol Design
AGINKO has the experience necessary to deal with the unique challenges of bone and cartilage studies. Our clinical protocol services span across all departments, integrating information from a wide range of expertise. The unique combination of medical, statistical, regulatory, and operational input is unmatched.
What this means to you is that with AGINKO's assistance, the design of your study will efficiently meet its stated objectives and allow you to plan the next set of trials with a high level of confidence. The bottom line is reduced clinical development time with possibly fewer patients and lower costs than expected.
Study Design Activities
- Defining the study hypothesis including the definition of key endpoints
- Writing the protocol
- Designing case report forms
- Organizing investigator meetings
- Determining the sample size and study duration
- Devising a statistical sampling plan to minimize exposure of patients to inferior and/or toxic treatments
- Writing interim analysis plans, including the usage of stopping rules for efficiency and futility
- Performing analysis planning and related data summary activities
- Providing regulatory guidance and insight
- Particular expertise in adaptive clinical trials and protocol design
