Clinical Trial Protocol and SAP Development
We know that the key to a successful COA measurement strategy
goes beyond identifying, modifying or adapting a measure to use.
Strategic advice and support
Clinical Outcomes Solutions provides strategic advice and support for clinical trial protocol and SAP development to ensure you obtain the quality of data from COA measures needed to support your overall objectives.
The appropriate implementation of the measure into your clinical trial and statistical analysis plan (SAP) is critical to the success of your product development program. This is recognised by regulatory authorities and is necessary to ensuring you obtain good quality COA data that you can trust and interpret from your clinical trials.
You will be required to demonstrate that the measure has been implemented into your clinical trial and statistical analysis plan (SAP) properly as part of regulatory interactions. Clinical Outcomes Solutions has years of experience, from time spent within industry and consulting with numerous companies, in supporting the appropriate implementation of COA measures into clinical trials in a way that is consistent with the:
- measure itself
- the study population
- clinical trial design
- and to support the target product profile or COA objectives.