Medical Device CRO
Medical device and pharmaceutical research programs differ fundamentally at the level of trial design and execution, as well as regulatory safety standards. At ethica CRO, we possess extensive experience in the conduct of medical device trials, so we are familiar with their unique features and the challenges that may arise.
Our prior medical device research experience lies within the following, non-exhaustive list of medical devices:
Dermal fillers, moisturizers, laser devices, bioelectronic devices, surgical implants.
Orthopaedic implants, tissue implants, bone void fillers.
Intra ocular lenses, corneal implants, ophthalmic wound care.
Do you want to learn more about how our clinical expertise can benefit your medical device study?
Our Risk-Based Approach to Medical Device Clinical Trials
One of the main differences between medical device clinical trials and pharmaceutical drug trials is the regulatory standards regarding the therapeutic product’s safety. It is especially important in medical device trials that data be communicated in a way that accurately reflects the risk profile of the device, which is why we follow a set of robust risk-based study monitoring procedures in our clinical management practices to ensure the study’s safety.
Our risk-based monitoring strategy encompasses—but is not limited to—the following practices:
- Development of a robust, detailed safety monitoring plan
- Centralized, remote, and on-site monitoring activities
- Use of Electronic Data Capture (EDC) system, offering:
- Real-time data entry and data management
- Remote identification of inconsistent data, outliers, potential protocol deviations, and site performance issues
- Active monitoring of participant safety and study quality
Since its inception, ethica CRO has completed over 31 medical device studies. The graphic below describes the percentage of studies per indication undertaken by our clinical trial project management team to this day:
Your CRO of Choice for Medical Device Clinical Research
Our team will help you:
- Identify the proper regulatory strategy
- Determine the appropriate outcomes measures to demonstrate the benefits of your device;
- Develop a robust, detailed safety monitoring plan to ensure research participants’ safety.
Case Study – How ethica CRO’s Risk-Based Approach Successfully Led to the Regulatory Approval of a Home Use (or Consumer Based) Medical Device
A prominent American dermatological device company approached ethica CRO to manage 2 of their registration studies investigating the efficacy of their novel handheld home use laser device for the treatment of fine lines and wrinkles. Our team provided a full range of study management and data management services from study start-up to closeout for these two studies.
During the study kick-off meeting, it was identified that participant recruitment may pose a challenge as the clientele of dermatological consumer-based devices may not be found easily through dermatology research facilities. ethica CRO proposed that the trials be conducted at a small Canadian cosmetic research facility. However, the site was unfamiliar with the conduct of more complex registration studies, did not have sufficiently robust SOPs for the level of research to be conducted, and did not have a dermatologist on staff.
ethica CRO developed a comprehensive risk management and quality improvement plan which involved assisting the site in bolstering its SOPs through general and study specific guidance and contracting in a consulting dermatologist for conducting efficacy and safety assessments. We provided thorough and continuous training to investigators and research assistants in order to ensure protocol and regulatory compliance. Lastly, we assisted the site in determining the most appropriate workflow to promote quality and efficiency.
Our efforts resulted in the successful completion of 2 randomized clinical trials, which yielded clinically significant improvements in fine lines and wrinkles and lead to the appropriate regulatory submission packages for the device to be approved by both the FDA and Health Canada for consumer use.