Clinical Trial Design
Medical Devices – Study Design
Study design is carried out as a separate project. Study design is reviewed against the EWMA Patient Outcome Group Recommendations for controlled and comparative studies on non-healing wounds* as well as ISO 14155:2020 and the CONSORT guidelines.
* Outcomes in controlled and comparative studies on non-healing wounds: Recommendations to improve the quality of evidence JWC Vol 19, No.6, June 2010 EWMA Patient Outcome Group.
CLINICAL TRIALS REQUIRE SUBSTANTIAL INVESTMENT OF YOUR TIME AND FINANCES:
- Wound Market Consulting’s experience of the wound care market provides the 360° perspective to ensure that your study delivers reliable and commercially relevant evidence.
- Our clinical trial design process identifies keys risks to provide confidence in the practicability of the study.
Clinical Trial Workflow
Time invested in the detail of the design of a Clinical Trial is amply repaid. Please see below for an example of a workflow for study design for an overview of the support and services available.
CONFIRM OBJECTIVES
We challenge and clarify your objectves for the study to ensure that the design will be fit for purpose.
1ST DRAFT STUDY DESIGN
The 1st draft study design is completed including sample size and other statistical modelling.
BEST PRACTICE REVIEW
Study design is reviewed against the EWMA Patient Outcome Group Recommendations for controlled & comparative studies on non-healing wounds* as well as ISO14155-1 & CONSORT.
RISK ASSESSMENT
We carry out a risk assessment of the practicability of the Study as well as for safety.
FINAL REVIEW
Final Design is passed through a multi-disciplinary review.
