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CASE STUDY #1
The Client:
A leading medical company that manufactures a range of transformative wound care and infection prevention products and technologies that are clinically proven to provide protection from complications.
The Project:
This client required support with their regulatory strategy, writing, and submission for their class III active wound care products. The client had already submitted their technical file to the Notified Body and received several open queries that needed to be resolved. A new systematic literature review protocol and report and Summary of Safety and Clinical Performance was required along with revised versions of several other clinical documents (the Clinical Evaluation Plan, Clinical Evaluation Report, Post-market Surveillance Plan, and the Post Market Clinical Follow-up Plan).
Notable above-and-beyond actions included:
- The development of a draft protocol for two clinical studies to collect additional safety and performance data.
- The successful execution of a meta-synthesis of clinical data to support an indication for use that had limited clinical data and was at risk of being removed by the Notified Body.
The Result:
The ECNE Research team provided an updated suite of clinical documentation within budget and well in advance of the deadline to resubmit to the Notified Body. The client hired the ECNE Research team to manage additional responses to the Notified Body, which led to a successful marketing approval under the EU Medical Device Regulations. The client has now hired the ECNE Research team to manage the clinical documentation for their entire portfolio of products.
CASE STUDY #2
The Client:
A leading medical device company that manufactures a highly novel implantable atrial device.
The Project:
The client required support with their regulatory strategy, writing, and submission for their class III implantable atrial device. Before engaging with ECNE Research, this client had sought support from a larger competitor company and had received several queries from the regulatory authority on the clinical documentation prepared by this competitor company. ECNE worked with the client to revise the Clinical Evaluation Report, Post Market Safety Update Report, and an Investigator Brochure.
Notable above-and-beyond actions included:
- The provision of tried-and-tested templates to enhance the chances of successful approval from the regulatory authority.
- Met regularly with the client team and closely partnered with them to ensure the smooth resubmission of the clinical documentation to the regulatory authority, and to provide advice on the regulatory strategy as a whole, drawing on industry insights.
The Result:
The regulatory authority approved all the clinical documentation that was edited by the ECNE team on the first submission. This client has now contracted the ECNE team for their annual clinical document updates including the systematic literature review, and the Clinical Evaluation Plan and Report.
CASE STUDY #3
The Client:
A leading mid-sized medical technology company that manufactures innovative radiotherapy solutions to deliver precise radiation treatments across a broad spectrum of patient needs, with a global reach extending innovative practices worldwide.
The Project:
The client required support with the authoring and editing value dossiers for two of their foremost radiotherapy products. Before engaging with ECNE Research, this client had sought support from several external consultants but was unsuccessful in finalizing the value dossier documents. They commissioned ECNE Research to work with a cross-disciplinary team to revise the value dossiers and met with the team regularly to ensure a smooth revision process.
Notable above-and-beyond actions included:
- The implementation of citation management software for the client team based on a need identified during project execution.
- The provision of training on the use of citation management software.
The Result:
The ECNE team worked with the client cross-disciplinary team to revise the value dossiers. The ECNE team met with the client team regularly to ensure a smooth revision process delivering the completed two value dossiers on time and within budget.
In the Client’s Words:
“Excellent service provided by the ECNE Research team. Very timely, efficient and professional work, kindly addressing our needs and demands. I warmly recommend Liz and the team as trusted partners!”
[Director Health Economics and Public Affairs]
CASE STUDY #4
The Client:
A startup medical technology company developing a self-powered, implantable device designed to restore tactile sensation in patients who have lost it due to injury or illness. The company uses innovative triboelectric nanogenerator technology to convert mechanical energy into electrical signals that can stimulate healthy sensory nerves to reestablish the sense of touch.
The Project:
The client required support with the development of a detailed global regulatory strategy. There were several complexities associated with the project including the novelty of the device and the need to understand evolving internal plans and strategies e.g., business development, marketing, clinical opportunity, and geographical considerations for market entry. The ECNE team performed a detailed analysis of the device, the business priorities, and the regulatory landscape to produce a step-by-step regulatory strategy for the EU and the USA.
Notable above-and-beyond actions included:
- The ECNE team dedicated a lot of time in the beginning to understanding the specific needs of the company and engaged in several discussion/planning meetings before completing a draft of the regulatory strategy.
- The strategy included details related to preclinical and clinical testing, as well as identifying several suggestions to accelerate regulatory approval and market entry.
The Result:
The detailed regulatory strategy was delivered on time and within budget. The client team had an opportunity to review and provide input to the strategy before completion. The client team were very pleased with the outcome and has engaged ECNE Research as their clinical-regulatory partner to build and implement a QMS, engage with the US FDA, and prepare preclinical and clinical protocols.
CASE STUDY #5
The Client:
A leading medical device company specializing in vascular visualization technology. Their products use near-infrared light to enhance the visibility of veins, assisting clinicians with procedures requiring vascular identification and access.
The Project:
The client required ongoing support with regulatory compliance, medical affairs and Key Opinion Leader (KOL) engagement, clinical study execution, and scientific publications. The ECNE team provided a wide variety of support including the development of educational materials, presentations, and abstracts; the preparation of manuscripts for submission to peer-reviewed journals; the design and execution of post-marketing clinical studies; the collection and analysis of clinical data; and the preparation of clinical documentation to support regulatory compliance.
Notable above-and-beyond actions included:
- The ECNE team successfully designed and executed five post-marketing clinical studies and supported the analysis and dissemination of findings for all studies.
The Result:
The ECNE team became an extension of the client company’s clinical and medical affairs team providing tailored solutions to align with the client’s evolving and growing needs.
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