Case study
Orthopedic Trial – meniscus repair.
D-TARGET 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. Some of the study data will even be used to obtain FDA regulatory approval. Read further to discover the success story.
Start up
The successful collaboration between the sponsor, our regulatory and our clinical department resulted in the identification of the clinical data needs. The regulatory department contributed to clear and to assure compliance with the appropriate regulatory requirements.
The clinical department contributed to realize the CIP, the 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 were of essential contents to obtain regulatory and market approval in EU.
Site Selection and contract negotiation
Together with the sponsor and the pre-identified PI, trial management group selected other potential study centers. Site selection and later contract negotiation were performed. Nine sites were confirmed in 4 different countries; Belgium, Germany, France and Spain.
Unfortunately, as often is the case with smaller orthopedic sites, many of the selected sites did not have sufficient support of a study nurse, or coordinator. Study compliance and quality of data turned out to be an issue.
Luckily, our experienced CRA’s were able to closely coach and guide the sites to comply with the study requirements; of course this resulted in higher maintenance of the sites, as well as onsite as remote, and thus in an adapted monitoring budget. A lot of work and time has gone into making the sites comply; D-TARGET was sufficiently flexible to meet these unexpected upcoming needs of the study and to make experienced resources available on the spot.
Study management
Study enrollment progressed even more quickly than foreseen. Having the CRA’s in close contact with and often at the sites to assist in complying with the study, resulted in high speed data collection.
The data processing and cleaning was performed simultaneously by a small company with whom D-TARGET had been working for longer time. Data was entered, queries released and resolved with the assistance of the site CRA’s.
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, no longer then 6 weeks after the last one year FU had been performed the data had been collected and processed for an interim report to obtain CE mark. CE mark was granted upon the condition to submit the final data and final report.
Safety and Compliance
D-TARGET’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.
Conclusion
It is with great team spirit, readiness to perform, expertise, dedication and flexibility that all members of the D-TARGET team, across many functional areas, worked together to fulfill the client’s expectations and ultimately gained market clearance of this novel device.