Clinical Operations
FLEXIBILITY WITH EXPERIENCE AND QUALITY
All members of our clinical operations team have extensive experience in running clinical studies and are in addition regularly trained in ICH-GCP/ISO 14155/20916, SOPs, guidelines, policies and practices to ensure studies are implemented and followed up with high quality.
Our global reach with local presence and offices result in good oversight, training and management of the team. We involve a local CRA from feasibility/selection up to the end of the study – leading to one main point of contact for the site.
Our CRAs can also be outsourced to you for your specific needs.
Feasibility and Site selection
Finding the right sites and investigators is key to your study success. With our large network of trial infrastructure and first hand experience with the sites, we can ensure that the right site is identified for your study based on your needs and project criteria. We offer great flexibility and have the ability to perform feasibility with short notice without loss of quality.
Study Start-up
The Study Start-up phase is an important part of clinical studies to reach important milestones such as first subject enrolled. Our CRAs in close collaboration with our Start-up group are always involved at an early stage of the study. They perform activities as local regulatory, ethics submissions and other required local submission (such as Biobank), site contract and budget negotiations and together creating a good collaboration with the sites from an early stage.
Site Management
Our CRAs are an essential part in developing a good working relationship with the site and the project manager through active communication and support throughout the conduct of a clinical study.
Monitoring
To ensure the success of your clinical study, our CRAs work closely with the sites to make sure that the study protocol is followed, informed consent is correctly obtained, adverse events are reported, relevant records are maintained and study drug or devices are accounted for and reconciled.
LINK Medical has CRAs in 6 countries and can perform local monitoring in the following countries; Norway, Sweden, Denmark, Finland, UK, Germany, Austria, Switzerland and in the Netherlands.
Risk-Based Monitoring
We apply a Risk-Based approach on all our full service studies, directing monitoring focus and activitites to the areas with greatest need.
Patient Recruitment and Retention
Recruitment and Retention of the right patients are key to the delivery of superior clinical outcomes. This is a continous process starting with optimal planning, discussions and follow up in collaboration with each investigator from study start and throughout the study.