Services offered by ClinCon
CRA/Monitoring activities
CRA/Monitoring activities during selection, initiation, maintenance and close-out of clinical studies. The activities include management of study sites during monitoring visits as well as remotely. Monitoring of study data, using paper or electronic CRF, assistance in contract negotiations with study sites and all other activities that will help executing a study successfully at a site. Monitoring is possible in hospitals in The Netherlands, Belgium and Great Britain.
Project Management
Management of a clinical study from start to finish, or individual parts, with clear communication and following previously agreed timelines and budget. Using knowledge of Dutch and European law and guidelines there is a lot of attention for site selection, training, patient recruitment and collection of high-quality data.
GCP training
Training in basic GCP (Good Clinical Practice) for companies and investigational sites. Possibilities for standard training or customized training with provided examples/questions from practical experience. The goal is to combine the rules and regulations with the daily practive of clinical research.
Assisting with submissions
Submissions of protocol(s) and other study related documents to Ethic Committees, Competent Authorities and hospitals to obtain approval.
Development of study documentation
Writing of study-related documents, for instance patient information brochure, monitoring guidelines or CRF pages, as well as general documents for clinical research, for instance SOPs or training materials.
Administrative support
Development and maintenance of study files (TMF and ISF) for sponsor and at clinical trial sites.