Our dedicated staff has vast experience in coordinating phase I to IV trials both locally and globally. We can perform all stages of clinical trials – from planning and feasibility phase to final study report – to the highest quality standards.
We have a wide therapeutic experience, excellent cooperation with site staff and customers, and in-depth knowledge of local requirements in all countries where we operate.
Our highly experienced Project Management team manages clinical trials in close cooperation with our customers. Our solid clinical background, open communication, flexibility and strong leadership form the basis for successful and smooth project management and study conduction.
Start up period:
- Consulting authorities for scientific advice
- Protocol writing
- Study team set-up
- Feasibility assessments
- Co-operation with potential investigators
- Operational set-up; e.g. plans, guidelines and manuals
- vendor selection and management
- Regulatory approvals (ethics committees, regulatory authorities, biobanks etc.)
- Site contract negotiations and management
- Investigator and CRA meetings
- Site initiation process
- Study subject recruitment planning, follow-up and reporting, contingency planning and actions
- eTMF/TMF Management and quality control processes
- Monitoring and site management
- Safety management and reporting
- Data Management
- Medical monitoring
- Close out process
- Vendor management
- Final data cleaning and database lock
- Statistical listings, tables and figures
- Study report and submissions
Our core expertise and focus is in the Nordic and Baltic countries, but we are able to cover other countries ourselves or through our qualified partner CROs.
Our flexible resourcing services provide the necessary professionals for your trials. Our experts can be field based, work from our premises or your own offices according to your wishes and needs. Flexibility, high quality and customer orientation are key benefits of the services we offer.