TRIAL MANAGEMENT
- Management of local as well international clinical trials
In collaboration with the local sponsor at Næstved Hospital, Oncological Department, we have performed the management of the international investigator-initiated clinical trial SCOT for the Danish sites for the last four years which is still ongoing, including the monitoring performed by the three Danish GCP-Units. - Handling of Regulatory affairs such as applications for the Ethics Committees, the Danish Health and Medicines Authority and the Danish Data Protection Agency.
- Monitoring of clinical trials of all phases according to the guidelines for Good Clinical Practice.
At the Phase I unit at CCBR in Aalborg we have performed the monitoring of a Phase I trial from the Spanish Medical Company Esteve.
- Arrangement of different kinds of meetings in relation to the trials.
- Educational activities including team development for the staff at clinical research units at hospital departments.
The research unit, oncological department Næstved is the country coordinating site in relation to the international SCOT Study, and during the last four years the staff has been trained in special tasks and will continue to do so.
- To be able to offer Coprehensive trial support for greater projects, we do collaborate with national organisations and institutions and with Contract Research Organisations (CRO) to ensure sufficient capacity and the best specialized knowledge and expertise tailored for the specific purpose.
Pharmacovigilance, Datamangement with electronic data capture, GCP-monitoring, collection of blood and tissue samples could be elements of a clinical research project to be performed in collaboration with a CRO or a national institution.
PREPARING OF STUDY DOCUMENTS
Seekuence® Multi-media system, Posicom
- preparing of protocols, description of procedures and design of clinical trial documents and files
- written patient information and consent Forms for patients or subjects
- preparation of clinical reports, drafts of articles for publication, posters and other kinds of presentations
- Posicom AS is a Norwegian provider of Video Management Solutions to several domains, i.e
Healthcare and the Maritime Industry. Our adaptive approach makes it easy
to implement the solution.
A web browser and a subscription is all you need to start using the system. - Posicom was established in 2000 and has delivered innovative multimedia solutions since year 2002.
- We guarantee scalability, flexibility, data integrity and security.
- Have a look at: www.Posicom.no
CONTACT
- Based on our great Network it should be possible to find a suitable collaborator for a specific research project, and to facilitate co-operation between clinical research units and the health care industry.
During the last decades of working with clinical trials, a great network of relationships have been built up within clinical research units in the health sector, in the medical industry and in Contract Research Organisations (CRO). During the participation in the international SCOT Study we have expanded our possibilities for contact with clinical research units at hospitals in Europe.