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.
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.