Medical Device Registry Trials
Registry trials (also known as observational studies or post-market surveillance studies) are types of clinical studies that collect data on the use and performance of medical devices in real-world settings, after the device has been approved for use by regulatory authorities.
The main goal of registry trials is to gather long-term safety and effectiveness data on medical devices, including information on how the device is used in routine clinical practice, the types of patients who use the device, and any adverse events or complications that occur. This information can be used to identify potential safety issues, to evaluate the performance of the device in different patient populations, and to inform the development of new devices.
Registry trials can be useful in providing information on the long-term safety and effectiveness of medical devices, but it should be noted that they have some limitations. They are typically not randomized controlled trials, and therefore, may not provide the same level of evidence as a randomized controlled trial. Additionally, data from registry trials may be affected by selection bias, which may limit the generalizability of the results.
How We Can Help Across Different Studies
- Drafting the research question and study objectives (primary & secondary)
- Sample size calaculation and study population characterization
- Drafting study protocols and seeking necessary IRB / IEC approvals
- Begining subject recruitment and completing study procedures as per protocol
- Performing data cleaning and completing statistical analysis to present outcomes
- Always meeting timelines and avoiding delays
Services We Offer
Registry trials typically involve the collection of data through a variety of methods, including patient interviews, surveys, and medical record review. Data may also be obtained through the use of device-specific data collection tools such as remote monitoring systems. The study design and methodology of registry trials can vary, with some studies being observational in nature and others being more of an interventional type.
We have helped Medical Device sponsors to create registries that can be used for:
> Short- and long-term surveillance
> Fulfillment of postmarket observational study commitments for regulatory bodies, and
> Examine comparative safety and effectiveness assessments, including those in under-studied subpopulations.