Encode Clinical Operations provide local management and monitoring of phase I-IV clinical trials. The Clinical Operations team has gained experience across several therapeutic areas, including:

• Cardiovascular
• Respiratory
• Dermatology
• Oncology
• Inflammatory RA
• Immunology
• Gastrointestinal
• CNS
• Glaucoma
• Haematology

Investigator identification and agreements

Encode provides sponsors with support for investigator identification and has in place a collaboration agreement with the Landspítali – The National University Hospital of Iceland which has proven to significantly shorten the time for finalization of investigator/institution agreements.

Local management and monitoring services

Today, Encode Clinical Operations employs five clinical research associates (CRAs) and one regulatory affairs associate (RAA). Standard operating procedures are in place addressing key activities and responsibilities. Work may also be conducted according to the sponsor’s procedures if requested.

Encode provides services to sponsors and investigators for submission of clinical trial authorisation (CTA) requests to the Icelandic competent authority, ethics committee and data protection authority. See more information here.

Encode supports its clients with import of investigational medicinal products to Iceland to ensure safe transport and compliance with local laws and regulations. Monitoring activities include:

• Pre-study visits to sites and laboratories
• Initiation visits and meetings
• Interim monitoring visits
• Source data verification
• Close out visits
• Study document handling
• Reporting of safety information
• Administrative tasks

Encode recognises that the key to a successful trial is a close relationship with the investigators and the study team and continuous support.