Encode: Clinical trial monitoring

Clinical Operations

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 – University Hospital 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.


About ENCODE		Clinical Operations	Regulatory Affairs	Clinic Services
	Clinical Operations 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 – University Hospital 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.