EU prospective study evaluating the efficacy and safety of a novel medical device

Background

Qmed Consulting was invited to plan, set-up and manage an EU open prospective study evaluating the efficacy and safety for a medical device to be used in the treatment of a particular condition with limited treatment options. The condition significantly limits the patient’s possibilities to take part in social activities. The investigational device was specifically developed for the indication. The study was conducted as a first-in-man study in one country in the EU. The sponsor had no previous experience from working with medical devices but had ample experience from working within the pharmaceutical industry.

The Challenge

The European-based sponsor of the study initially categorised the product as a pharmaceutical product, but during the clinical strategy process it was revealed that the product should be classified as a medical device. The sponsor needed to gather all relevant information related to technical and clinical documentation needed to carry out this medical device clinical trial. In addition to this challenge, very limited company resources were available for the project.

The Solution

The appointment of Qmed Consulting as a regulatory and clinical advisor/CRO was based on their extensive knowledge within high-risk and borderline medical. Solutions provided by Qmed Consulting included:

  • Ensuring that the investigational device was manufactured according to relevant medical device guidelines and regulations, including the validation of sub-suppliers
  • Developing and providing technical documentation for the device , including risk analysis, biological evaluation, IFU and relevant bench testing
  • Developing a protocol and ensuring that it was in compliance with medical device good clinical practice and other relevant directives
  • Providing an ISO 14155 compliant quality system, eCRF, statistical service, monitoring, and medical writing services from project initiation until last subject last visit (including 30 subjects with 6 months follow up) during a period of only 18 months.

Conclusion

The outcome of the study revealed that the device worked as intended, the device provided the desired effect resulting in a statistically significant outcome for the patient included in the study. Subsequently, the data obtained from this first-in-man study were also strong enough to approve the subsequent CE-marking application of the device.

Through expert knowledge and experience within the field of medical devices, Qmed Consulting could handle a project, which would otherwise be very hard for the sponsor to manage. Qmed Consulting successfully demonstrate that the device is a valuable treatment option for the target patient population. The project was planned and carried out rapidly, efficiently and cost-effectively for the sponsor. Qmed Consulting thus successfully solved the assignment saving the sponsor from longer project timelines and more expensive in-house solutions as a result of handling the assignment within the company’s own setting.

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