Our extensive experience and knowledge can help you plan an optimal study design. In addition to our internal expertise, you can get direct market feedback through meetings with panels of clinical experts. Let us be your bridge to the key opinion leaders and surgical experts throughout the United States and Europe.
Having an outline on how your study will look like is one thing; having a protocol (clinical investigation plan) ready for regulatory submissions, is another. Our team of medical writers is well equipped to develop the protocol that you will be looking for. For studies to be performed and/or data to be submitted in Europe, the protocol will be written according to the ISO 14155 standard. For studies to be performed and/or data to be submitted in the United States, we combine our knowledge on ISO 14155 (generally acknowledged by the FDA) with FDA guidance and expectations.
Post-market surveillance / post-market clinical follow-up
Submission of a post-market surveillance (PMS) plan and/or a post-market clinical follow-up (PMCF) plan has become common practice in both the United States (FDA) and Europe (Notified Bodies). In Europe, your new device may not even get CE-marking approval before an appropriate PMCF plan has been provided to the Notified Body. We are looking forward to helping you drafting such plans, in line with FDA and Medical Device Regulation (MDR) requirements.
Our experience and knowledge can help you plan an optimal post-market clinical study design. The range of designs for post-market studies is broad, running from relatively simple registry studies, to extensive randomized controlled trials. We can assist you in designing the optimal study design for your device, with its specific risk classification and specific characteristics.
The introduction of the MEDDEV 2.7/1 Rev. 4, in June 2016, is part of the significant changes happening across the medical device regulatory landscape. Although writing of Clinical Evaluation Reports (CERs) was already a requirement for EU compliance, the previous revision of this MEDDEV didn’t provide much structure – neither to the manufacturer or to the Notified Body. This has been changed. The MEDDEV update made the Notified Bodies change their process, focusing on detail and now expecting a considerable effort from the manufacturer, for all device classes, whether already on the market for a long time, or newly introduced. Factory has an expert team of medical writers that has the knowledge and experience requirements for evaluators as outlined in the MEDDEV. We can help you compiling CERs, making sure you do it right the first time so you don’t lose time and resources.
Reporting of study results
Your study does not end once the last subject has been treated – it is key to ensure a clinical study report (clinical investigation report) is compiled, to ensure your data is transferred to the authorities and others in a timely and appropriate manner. The medical writers at Factory are extensively trained on the standards in the United States (ICH E6) and in Europe (ISO 14155). Has your study been performed in both the United States and Europe, or do you want to submit your data to both the FDA and a Notified Body? No problem, we are looking forward to work together combining the best of both guidelines.
Scientific Literature Review
The one manufacturer makes it part of its clinical evaluation, for the other it may be worth to first have a scientific literature review performed before running into, in example, the design of a clinical trial. In any case, Factory’s medical writers are well educated in performing systematic scientific literature reviews, on any topic wished for.
The Investigator’s Brochure brings all clinical and non-clinical information on your device with respect to safety and performance together in one document, functioning as one of the primary information sources to the investigator. The Investigator’s Brochure is an essential document during your pre-market clinical trial, both in the United States and in Europe. With our experience in numerous pre-market clinical trials, we have an excellent basis to help you design an Investigator’s Brochure, according to the ISO 14155 and/or ICH E6 standards.