Crossover has developed a clinical trials database for its partner hospitals and investigators containing about 100 key project management parameters per clinical trial in their portfolios. The database is called COCTML (Crossover Clinical Trials Master List). With a suitable ID and Password, study information is accessible 24/24 and 7/7 from anywhere in the world to hospital personnel via the Crossover website. The data is continuously updated by Crossover Clinical Study Coordinators and Business Development staff at the Clinical Research Units serving each hospital in the Network. Access rights are restricted by hospital and by department and are read-only.
One feature of COCTML is the table with visits, which shows the monetary value of each visit in the clinical trial agreement, and has columns with actual patient numbers in the study and the date of each visit performed by the patient. Another feature of COCTML is a computer link to the ClinicalTrials.gov database monograph, if available.
Crossover believes that an important element of the clinical research governance which is expected today from healthcare institutions involved in clinical research is the master list of their clinical trials. This is extremely difficult to develop at healthcare institutions without the help of a central Clinical Research Unit. However, with such a master list, the hospital can derive very useful performance calculations and graphs, such as
- lists of sponsors and CROs placing studies at their institutions,
- lists showing the intensity of trials by department and investigator,
- enrollment curves per trial or department or the entire institution by year,
- Gantt charts showing the trials against a time scale, the phases of activity they are in, the patients entering the trials and the visits produced.
Since the 2008 peak in the number of new trials reported by industry sponsors to the NIH datbase clinicaltrials.gov, we observe an annual decline in the number of new trials of about 10% in the World, and of about 15% in Western Europe. Certain countries like Belgium and particularly Bulgaria are worse off. Pediatric trials follow the same trend. Link
Crossover president appointed as expert reviewer of pharma projects submitted to Region of Brussels innovation center.
Jean-Pierre Tassignon, President and CEO of Crossover CRI AG (CRI= Clinical Research Infrastructures) has been appointed as an independent expert reviewer with INNOVIRIS, the Brussels Institute for Research and Innovation, an official institution set up by the government of the Region of Brussels to support early innovative projects with industrial potential. He will be working on projects that have a development opportunity in the pharmaceutical sector.
EFGCP In-house training course for experienced researchers at two hospitals in Brussels.
The European Forum for Good Clinical Practice has created a training course for experienced researchers, which has been provided in-house at several pharmaceutical companies and at the European Organisation for Research on the Treatment of Cancer (EORTC). It is the first time that the course is provided on campus at hospitals. Sponsoring the event were the Brugmann University Hospital (Brugmann UH), the Queen Fabiola Children’s University Hospital (QFCUH) in Brussels, Belgium and Crossover, which operates the Clinical Research Unit at these two healthcare institutions with 4 hospital sites in the north of Brussels. The EFGCP lecturers were Dr Frank Wells, Dr Ingrid Klingmann and Geneviève Decoster. This full-day course attracted 60 doctors from all departments, the staff from the Clinical Research Unit, as well as a few nurses. The purpose was to boost the knowledge of GCP of staff involved in clinical research at these institutions in the wake of a multiplication of clinical trials. The organizers selected the EFGCP because of the high quality content and panel provided by the EFGCP and the robust experience the EFGCP has gained with the course in Europe. Brugmann UH and QFCUH can now document an intensive clinical research training by an external group of 10% of all doctors working at these institutions. Training in clinical research is taken very seriously and will continue with various methods and events.