Feasibility and site selection
Assessment of whether a site and its patient population can support the proposed study.
Services
IRIS is registered for the wholesale trade of medical devices in Albania. Beyond supply, the work divides as follows.
Technical support and servicing
Maintenance, fault diagnosis and repair of the equipment supplied. Where work is not carried out by us, the request passes to the manufacturer and we follow it through to closure.
Installation and commissioning
Installation on site, connection to existing infrastructure, functional testing and handover of equipment ready for use.
Training for clinical staff
We train the doctors, nurses, embryologists and laboratory staff, at their place of work and on the equipment itself.
Regulatory and import handling
Handling the regulatory and import procedures for the products supplied, through to delivery at the institution.
These four commitments apply the same way whether the buyer is a public hospital, a private clinic, a fertility centre or a laboratory.
Clinical research
IRIS is prepared to act as a contract research organisation for institutions and sponsors conducting clinical research in Albania. The scope of work we are prepared to provide runs from a study’s initial assessment through to its close:
Protocol and submission support
Preparation of the documentation that accompanies the protocol for submission to the ethics committee and the regulatory authority.
Ethics and regulatory dossiers
Compilation of the dossier the ethics committee requires, including the protocol, the investigator’s brochure, the informed consent form and recruitment materials.
Site initiation
A site initiation visit that reviews the protocol, case report forms and study procedures with the investigator and site staff before patient enrolment begins.
Monitoring
Source data verification, cross-checking case report forms against the original clinical documentation, and checking protocol compliance throughout the study.
Data collection and management
Review of collected data for completeness and consistency, and raising queries with the site when a discrepancy is found.
Safety reporting
Assessment of the causality and seriousness of any adverse event, and reporting within the timelines the protocol and the regulator require.
Close-out
A final site visit, database lock, reconciliation of study materials, and archiving of the study documentation.