Premier Research has recently supported an orthopedic device manufacturer from concept to successful CE-Mark application and market clearance in Europe for their novel partial meniscus replacement device. In addition, data from this study will be used to obtain FDA regulatory approval.
The successful collaboration between the sponsor and our regulatory and clinical departments resulted in the identification of the clinical data needs. The regulatory department contributed by providing a clear compliance with the appropriate regulatory requirements.
The clinical department contributed by developing the CIP, CRFs, ISF and PICs accordingly. Cross checks amongst the study documents from the different departments assured that data would be of sufficient quality and that the study documents contained the essential information needed to obtain regulatory and market approval in EU.
Site Selection and Contract Negotiation
Together with the sponsor and the pre-identified PI, our trial management group selected other potential study centers. The team performed the site selection and contract negotiation which includednine sites in four different countries (Belgium, Germany, France and Spain).
Unfortunately, as can be the case with smaller orthopedic sites, many of the selected sites did not have the sufficient support needed from a study nurse or coordinator which may have resulting in low study compliance and poor quality of data. Luckily, our experienced CRAs were able to closely coach and guide the sites to comply with the study requirements. Our team at Premier Research was sufficiently flexible in order to meet these unexpected needs and provide experienced resources for more in-depth site management and monitoring.
Study enrollment progressed more quickly than foreseen. Having the CRAs in close contact with and often at the sites to assist in complying with the study, resulted in high speed data collection.
The project manager oversaw all these processes and was able to adhere to very prompt timelines in order to facilitate interim analysis. These preliminary reports were used by the company to obtain new capital of investors in this very promising product.
Additionally six weeks after the last one year follow-up subject visit had been completed, the data was collected and processed for an interim report to obtain CE mark. The CE mark was granted upon the condition to submit the final data and final report.
Safety and Compliance
Premier Research’s dedicated medical device safety officer continuously monitored patients’ safety and reported any reportable event to the regulatory authorities, taking this essential responsibility with great expertise out of the hands of the small company.
Thanks to the dedicated support and team approach of Premier Research project team, the sponsor’s needs were met, and the device gained CE Mark in time.