The client from Asia, who could not perform the clinical trial due to the specific and limited study group turned to Clinmark for help in finding a solution to test medical device they invented. In this situation, the best option was to perform a cadaver study, which Clinmark did starting from finding the right site and writing the protocol. The course of the study and its results proved successful, allowing the medical device to be registered with the Chinese FDA.
In a phase I oncology trial conducted by a Sponsor from France, two patients needed to be enrolled to reach the recruitment goal. Clinmark conducted feasibility in three countries within only 7 days: Bulgaria, Poland and Slovenia, of which Slovenia was selected and the submission to the EC and RA. Hospital in Ljubljana recruited last two patients.
The sponsor decided to add Clinmark to its ongoing clinical trial to be responsible for sites in Poland. Poland very quickly became an important recruitment target and the sponsor decided to appoint Clinmark directly to manage the following countries Bulgaria, Hungary, Romania, Italy and the Czech Republic.
A clinical trial in Europe for the indication colitis ulcerosa was experiencing difficulties in recruiting patients. To speed up recruitment, Clinmark implemented an investigator incentive scheme within seven days, which had a positive effect and recruited the expected patient pool.
Closeouts in Bosnia
In an international clinical trial involving several CROs, one CRO lost its operational capacity and ceased operations after the end of the active patient recruitment phase. This resulted in the sponsor being unable to liaise with the local CRO and conduct COV visits for several years. After Clinmark’s proposal was accepted, COV visits were performed by monitors from Poland. They overcame a number of difficulties in reaching the investigators, arranging appointments and carrying out all the visits within two weeks as the sites were located in a mountainous country. In addition, one of the hospitals had great difficulty in locating the study documents, and when they managed to do so after the appointment, the monitors returned to the site to complete the COV.
Clinmark’s strategy is to look for the blue ocean, i.e. the countries that will be most suitable for clinical trials in the future. As part of this strategy, Clinmark contacted scientific institutions in African countries. This led to contact with Cameroon and a series of meetings with scientific institutions and the Cameroonian Prime Minister during Clinmark’s visit to the country. During the meeting with the Prime Minister, Clinmark outlined the changes that needed to be made in order to conduct clinical trials in Cameroon.
Clinmark has developed specific tools and a methodology called Smart Global to help sponsors run projects in many different countries. It enables studies to be conducted in 18 European countries and other selected countries outside Europe. An interesting feature is the possibility to carry out monitoring visits directly in the countries where the study is taking place.
Clinmark supports innovative companies that produce and introduce new technologies, including in clinical trials. One company that Clinmark has actively supported and provided expert validation for is Virtual Monitor.