Biostatistics for Medical Device Clinical Studies

Long before a clinical study of your medical device goes into the field, our biostatistician conducts a thorough assessment of the requirements to support a regulatory submission to ensure that your clinical study is planned with the proper enrollment. This pre-clinical biostatistical analysis is very important as under-enrollment can lead to significant market entry delays and over-enrollment can waste money.

Clinical Study Design Solutions

Proper protocol design and analysis will improve the quality of your medical device clinical study submission, control costs and accelerate the introduction of your product to market. Here are some of the clinical study biostatistics services we offer:

• Protocol design and sample size calculations and justification.
• Clinical trial database design and validation.
• Creation of statistical summary tables and reports needed for regulatory submissions.
• Bayesian statistical analysis.
• Final statistical analysis and reporting.
• Extraction of valid datasets for scientific papers or regulatory submissions.

Medical device manufacturers increasingly need to conduct post-market clinical follow-up (PMCF) investigations to collect additional information about a product already approved for sale in Europe. Your PMCF plan and PMCF studies are essential to maintaining compliance under the new Medical Devices Regulation (MDR 2017/745), but many companies feel overwhelmed and confused by the new requirements. Pepgra global consulting team can assist with all aspects of MDR compliance, including planning, evaluating, and conducting PMCF studies for medical devices.

When to conduct PMCF studies for medical devices in Europe

A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.

You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.

When to update your device CER

The initial report is just the beginning of your CER’s lifecycle. Update your CER regularly based on ongoing clinical evaluations, or as part of your post-market surveillance and vigilance operations. Updates to your CER are required:

• Every year, or...
• When you receive new information from post-market surveillance that could change the current evaluation, or...
• Every 2-5 years if the device is not expected to carry significant risks and is well established.

We can assist with your EU Clinical Evaluation Reports and literature reviews

Pepgra specializes in reviewing medical device clinical data, and we can ensure your CER meets all European requirements. Our expert team of regulatory consultants brings depth of clinical experience with a range of medical devices and IVDs. We can:

• Gather and analyze appropriate scientific literature applicable to your device.
• Compile and draft the CER in compliance with EU requirements.
• Develop procedures to compile CERs and perform clinical literature reviews for future updates to your CER.
• If necessary, we can develop a protocol to methodologically search and evaluate journal articles and provide a synopsis.

Contact us for more information about how we can help you comply with MEDDEV 2.7/1 rev 4 and perform literature reviews.