Vistor's Encode - Clinical Operations provide local management and monitoring services of clinical trials. Iceland is a member of the European Economic Area and follows The European Clinical Trials Directive 2001/20/EB and regulation on clinical trials of medicinal products in humans. We ensure compliance with regulatory requirements and International Conference on Harmonization’s Good Clinical Practice Guideline. We base our work on our customer’s standard operating procedures as well as our own local standard operating procedures.
We have 14 years of experience of clinical trials within several therapeutic areas, including
cardiovascular, CNS, diabetes, gastrointestinal, nephrology, oncology and respiratory.
Local management and monitoring services
Our services include:
- Administrative tasks and agreements.
- Site selection and investigator identification.
- Submission of clinical trial authorization requests to the Icelandic competent authority (Icelandic Medicines Agency), ethics committee (National Bioethics Committee) and data protection authority (The Personal Data Act).
- Handling of study documents and translation.
- Production of support material.
- Local startup meetings and training of study teams.
- Monitoring service, including all monitoring activities such as pre-study visits, initiation visits, monitoring visits, closure visits, local meetings, source data verification and safety information reporting.
- Financial matters.
- Import of investigational medicinal products through partnership with our sister company Distica, a first class distribution company with an ISO9001 certified distribution and warehousing system.
- After study closure we can offer archiving of documents and files.
For further information please contact Gunnur Petra Thorsdottir, Clinical Operations Manager, (email@example.com).