Site Monitoring

Overseeing trial sites to protect participant rights, ensure data integrity and verify protocol compliance across Scandinavia.

Overview

Site monitoring ensures the participants’ rights, safety and well-being and the reliability of trial results as the trial progresses. Clinical trial sites operate in compliance with the study protocol, GCP guidelines and applicable national regulations.

Nordic Trial Partners provides experienced monitoring services across Sweden, Norway and Denmark, working on behalf of sponsors and CROs to maintain oversight of trial site activities.

What this covers

Initiation, routine and close-out monitoring visits
Remote monitoring and source data verification
Protocol compliance verification
Informed consent review and documentation checks
Investigational product accountability
Safety reporting and adverse event follow-up
Site file maintenance and TMF readiness
Corrective and preventive action follow-up

Standards

All monitoring is conducted in accordance with ICH-GCP E6 R3, ISO 14155:2026 (for medical devices), the study protocol and applicable national regulations in Sweden, Norway and Denmark.

Who this is for

Sponsors and CROs needing experienced monitoring coverage at Scandinavian trial sites. Particularly suited to companies without local staff in one or more of the Nordic countries, or those needing to scale monitoring capacity for ongoing studies.

Coverage

Sweden, Norway and Denmark. Local presence across all three Scandinavian countries.

Sectors

Pharmaceuticals (Phase I-IV) and medical devices (pre- and post-market).

Get in touch

Discuss how Nordic Trial Partners can support your project.

Contact Nordic Trial Partners

— CASE EXAMPLE

Site Monitoring in Practice

ANONYMISED CASE STUDY

A failing trial site turned around before it was closed

The challenge:

A global mid-sized CRO was running a Phase II orthopaedics trial, a knee cartilage implant, for a large pharmaceutical company. After centralised data monitoring and concerns about the assigned monitor, a site in Norway was audited. The senior QA auditor found quality so poor that the data could not be used and the site faced early closure. Critical findings, across all six participants, included an incorrect informed consent process, late reporting of serious adverse events and missing source data. The investigator lacked GCP knowledge and engagement, and the monitor was unresponsive.

What we did:

Our senior consultant took over as site monitor with two months to resolve every finding before a re-audit by the same auditor. He met the investigator to set expectations and explain the risk of closure and a possible serious breach. A separate meeting with the study nurse uncovered the real problem: she was carrying most of the trial work, unpaid and unsupported. Together with the site, a joint plan was agreed: regular calls and reporting between visits, strict follow-up of the trial agreement, full ICH-GCP retraining focused on practical application, and steady support for the site staff.

The outcome:

Two months later the site was re-audited with no Critical or Major findings. The clinical data was fully usable in the trial results.

— RELATED SERVICES

Other Services

Clinical Operations

Strategic and operational oversight of clinical programmes. Cross-functional team leadership, budget and timeline management.

Learn more →

Study Start-Up

Site identification, feasibility, contract negotiations and regulatory submissions across Sweden, Norway and Denmark.